NMC 16 May/June

What Can Help for a Calmer and Deeper Sleep / Melatonin: Beyond Sleep – a Multifunctional Hormone / Beta-Glucans: Bioactive Polysaccharides with Significant Potential / GLP-1: Implications for the Industry / Cosmetovigilance

Editor's Word

Welcome to the May/June edition of B2B Nutramedic&Cosmetics.

In this issue, we highlight the powerful promise of beta-glucans as bioactive polysaccharides and spotlight Sulfodyne® from Ingood by Olga, offering renewed hope for women's health. We also explore the means of achieving more restful and deeper sleep and the versatile roles played by melatonin beyond sleep assistance. Our Formulating Product Guide examines the business repercussions of GLP-1 trends, while editorial on maximising men's health addresses the growing emphasis on male wellness.

On the cosmetics front, we emphasise the need for cosmetovigilance and celebrate industry innovation, with BASF's BSB awards and the novel promise of Moldavian dragonhead extract. We cover the Vitafoods Europe Innovation Awards 2025 previews. Key news from Lallemand, Aker BioMarine, and clinical studies on Verisol further strengthen this issue. We are also proud to be an official Media Partner of Vitafoods Europe 2025, strengthening our connection to the pulse of global food supplement industry innovation.

Thank you for your ongoing support. Enjoy the issue and see you in Barcelona!

Best regards,

Daria Šurić, MPharm, univ.spec.pharm.

EDITOR-IN-CHIEF B2B Nutramedic&Cosmetics Magazine

Content

4

Beta-Glucans: Bioactive Polysaccharides with Significant Potential

12 Ingood by Olga Presents Sulfodyne® for Women's Health

14 What Can Help for a Calmer and Deeper Sleep?

18

Melatonin: Beyond Sleep –a Multifunctional Hormone

22

FORMULATING PRODUCT GUIDE: GLP-1: Implications for the Industry

Bimonthly digital magazine for industry professionals in health, nutrition and cosmetics sector

Bimonthly digital magazine for industry professionals in health, nutrition and cosmetics sector

Ingredients and raw materials / Contract manufacturing Equipment & Packaging / Services / Industry events www.nmc-magazine.com info@nmc-magazine.com

Ingredients and raw materials / Contract manufacturing Equipment & Packaging / Services / Industry events info@nmc-magazine.com

24

Optimizing Men's Health

Publisher: Darmell d.o.o.

Publisher: Darmell Ltd.

Cvjetna cesta 11, 10000 Zagreb, Hrvatska Mob: + 385 91 68 12 444 darmell@protonmail.com www.dar-mell.com

Cvjetna cesta 11, 10000 Zagreb, Croatia Mob: + 385 91 68 12 444 darmell@protonmail.com www.dar-mell.com

Supported by www.inpharma.hr

27 B2B Events Calendar

The publisher does not assume responsibility for the opinions and data that the authors present in the magazine, as well as for the data and materials provided by companies for publication in texts and advertisements. It is not allowed to reuse any part of the content without the prior consent of the publisher.

The publisher does not assume responsibility for the opinions and data that the authors present in the magazine, as well as for the data and materials provided by companies for publication in texts and advertisements. It is not allowed to reuse any part of the content without the prior consent of the publisher.

Beta-Glucans: Bioactive Polysaccharides with Significant Potential for Health and Industrial Use

β-Glucans are natural polysaccharides with well-documented health benefits, including immune modulation, cholesterol reduction, and glycemic control. Found in cereals, fungi, yeast, and algae, their bioactivity strongly depends on molecular structure and source. With growing interest in functional foods, supplements, cosmetics, and medical applications, β-glucans are gaining attention as multifunctional ingredients. This article explores their structure, mechanisms of action, and broad potential across health and industry sectors.

AUTHOR: Sara Kralj, MSc, Master in Nutrition

Introduction

Glucans are among the most abundant organic polymers on Earth. Due to the bulkiness and rigidity of glucose, the basic monomer from which they are composed, glucans are also structurally rigid molecules1. Their unique properties primarily arise from the specific glycosidic bonds linking individual glucose units. In nature, glucans play an important role in numerous physiological processes2.

Glucans with β-glycosidic bonds are primarily involved in intracellular energy storage, as is the case with starch (β-1,4-glucan). In contrast, β-glycosidically linked glucans typically participate in the formation of structural components of cell walls, such

as in cellulose (β-1,4-glucan). Both isomers of glycosidic linkage, β and β, are also found in microbial exopolysaccharides, where they play a key role in cellular protection, adherence to solid surfaces, and intercellular communication2,3 β-glucan stands out as a particularly promising bioactive compound due to its beneficial properties, which are comparable to and in some cases superior to those of other polysaccharides4.

Beta-glucan

β-glucan is considered a bioactive food component due to its diverse biological activities. It is naturally found in various sources such as bacteria, fun-

gi, algae, cereals (barley and oats), and yeast. Additional sources include marine algae and various medicinal mushrooms (e.g., Lentinula edodes – Shiitake, Ganoderma lucidum – Lingzhi, Inonotus obliquus –Chaga, Grifola frondosa – Maitake), which have been the focus of research due to their potential immunomodulatory and antitumor properties.

Structure and bioactivity of β-glucans

Although the basic structural units of β-glucans from different sources exhibit a high degree of similarity, numerous studies indicate that their biological activities can vary significantly. This variability arises from differences in polymer chain length, type and position of glycosidic linkages, degree and pattern of branching, and conformational (three-dimensional) structure, despite the presence of common β-glycosidic bonds between glucose units. These structural features play a crucial role in determining the biological activity and functional properties of individual β-glucans. In aqueous solutions, polysaccharides can form complex supramolecular structures due to intra- and intermolecular interactions, such as hydrogen bonding, including random coils, single, double, and triple helices, as well as aggregates like short rods and filamentous structures.

β-glucans are polymers composed of glucose subunits linked by glycosidic bonds, often branched at the sixth position of the backbone. They primarily consist of a linear core of β-1,3-d-glucose units, with a variable degree of branching involving side β-1,4 or

β-1,6 glycosidic linkages, depending on the biological source. Yeasts and fungi contain β-1,6 branches, while cereals contain β-1,4 side chains. Depending on their origin, there are variations in the structural complexity of β-glucan molecules, their impact on biological activity, pharmacological potential, and physicochemical properties such as solubility, viscosity, gelling capacity, and molecular weight. The degree of branching of β­glucans from different sources is shown in Figure 1.

β-glucans exhibit diverse mechanisms of biological activity that are directly related to the specific features of their conformation, i.e., to well­defined structure–function relationships. Among the most well-known biologically active fungal polysaccharides are schizophyllan, lentinan, and scleroglucan, which, under most experimental conditions, form a stable triple-helix conformation.

Immune system

Historical records testify to the millennia-long use of mushrooms for medicinal purposes. Ancient Indian texts dating back approximately 5000 years, Japanese legends about Lentinula edodes , as well as the practices of African shamans and Native Americans, point to an early intuitive recognition of their beneficial effects.

Immunomodulators are substances capable of modulating the immune response - either by enhancing or suppressing it. They include a broad range of natural, synthetic, and recombinant molecules, such as

FIGURE 1 Schematic representation of the structure and degree of branching of β-glucans from different sources11

curcumin, resveratrol, flavonoids, and plant extracts. However, comprehensive scientific research is lacking for the majority of natural immunomodulators. Comparative studies have shown that β-glucans consistently exhibit strong biological effects.

β-1,3-glucans (glucans) are highly conserved pathogen-associated molecular patterns (PAMPs) that the immune system recognizes as foreign structures. The first reports of their immunomodulatory activity date back to the 1940s, when a polysaccharide extracted from Serratiamarcescenswas found to possess antitumor properties. Subsequent studies confirmed the presence of glucose residues within it. For safety reasons, research later shifted to glucans derived from non-toxic sources such as mushrooms, yeasts, and plants. Evolutionarily, the ability to recognize glucans is present across all multicellular organisms, from invertebrates to humans.

Glucans are considered potent activators of cellular immunity, with macrophages being the most important biological targets. Early studies demonstrated that glucan provided protection against infections caused by Leishmania major, L. donovani, Candidaalbicans,Toxoplasmagondii,Streptococcussuis, Plasmodiumberghei,Staphylococcusaureus,Escherichia coli, Mesocestoides corti, Trypanosoma cruzi, Eimeria vermiformis and Bacillus anthracis19

Antitumor and immunomodulatory

effects

Cancer is a complex and heterogeneous group of diseases characterized by uncontrolled cell proliferation and represents one of the greatest challenges in modern medicine. It is the second leading cause of death worldwide, accounting for approximately one in six deaths, with nearly 19.3 million new diagnoses and about 10 million deaths annually. Standard therapies - surgery, chemotherapy, and radiotherapyare still associated with significant side effects and limited efficacy.

β-glucan demonstrates pronounced anticarcinogenic potential through immunomodulatory mechanisms that prevent oncogenesis and inhibit the metastatic development of tumors. Its action is based on a multifaceted approach: direct inhibition of tumor growth, stimulation of the immune response, and intrinsic antitumor properties. The effectiveness of β-glucan depends on its source, molecular structure, branching pattern, and chemical modifications. The immune response encompasses innate and adaptive mechanisms involved in the recognition and elimination of pathogens and the maintenance of organismal homeostasis. High-molecular-weight β-glucans, particularly those from fungi and yeasts with a high degree of branching and (1→3)­ and (1→6)­β-glycosidic linkages, exhibit potent immunomodulatory activity primarily by acting on components of the innate immune system. Due to their repetitive structure, β­glucans bind to specific receptors on immune cells, including dectin-1 (mainly insoluble β-glucans), CR3, and TLR2 (mainly soluble β-glucans), thereby activating a signaling cascade that results in enhanced phagocytosis, antigen presentation, production of reactive oxygen species (ROS), and secretion of cytokines and chemokines. These secreted cytokines further stimulate the adaptive immune response by activating B and T lympho-

cytes, thus promoting both humoral and cell-mediated immunity.

β-glucans can modulate the tumor microenvironment (TME) by transforming immunosuppressive cells into immunostimulatory ones, thereby enhancing the antitumor immune response. Clinical studies have shown that combining glucans (e.g., PGG, a derivative of YBG) with monoclonal antibodies improves remission outcomes and reduces tumor burden in patients with small-cell lung cancer. Furthermore, polysaccharides from Ganodermalucidum have been shown to induce dendritic cell maturation and modulate the cytokine profile in lung cancer patients after 12 weeks of therapy. To increase the anticarcinogenic efficacy of β-glucans, it is crucial to ensure their precise distribution within the body and effective interaction with the immune system, underscoring the importance of understanding β-glucan pharmacokinetics and trafficking mechanisms. Although oral administration is the most common mode of intake, β-glucans can also be administered intraperitoneally (IP) or intravenously (IV), though these routes are less common.

After oral administration, β-glucans reach the proximal part of the small intestine, where they are phagocytosed by intestinal epithelial cells or M cells (microfold pinocytic cells). They are then transported to immune cells in Peyer's patches, where they are taken up by gastrointestinal macrophages. These macrophages then migrate via the bloodstream to lymph nodes, where β-glucan activates dendritic cells. Dendritic cells capture and phagocytose damaged tumor cells within the tumor microenvironment, which stimulates the activation and differentiation of antigen­specific CD4+ and CD8+ T lymphocytes. Degraded β-glucan fragments further activate neutrophils by binding to complement receptor 3 (CR3), while simultaneously modulating myeloid progenitor cells in the bone marrow. These processes trigger CD3/CR3-dependent cellular cytotoxicity (CR3-DCC) directed against opsonized tumor cells coated with iC3b.

Orally administered β-glucan additionally induces a respiratory burst, increases phagocytosis rates, and enhances the secretion of key cytokines, including interleukin-1 (IL-1), IL-6, and TNF-α, within macrophages. It also regulates the acute phase of the humoral immune response and increases the activity of lysozyme and ceruloplasmin in animal models. All these mechanisms collectively confirm the multidimensional potential of β-glucans in oncological immunotherapy and immunomodulation.

Role of β-glucan in the gut microbiota

The gut microbiota, often referred to as the "second brain," is crucial for maintaining health. Its ability to break down β­glucan, a type of dietary fiber (DF), contributes to gut homeostasis. An imbalance in the microbiota can increase intestinal permeability, cause inflammation, and contribute to the development of colorectal cancer. The microbiota comprises more than 100 trillion microorganisms involved in various processes, including vitamin biosynthesis, angiogenesis, and metabolic regulation.

Indigestible polysaccharides like β-glucan promote the growth of beneficial bacteria (e.g., Lactobacillus and Bifidobacterium) and the production of

short-chain fatty acids (SCFAs) such as acetate, propionate, and butyrate, which have a positive effect on gut health. Fermentation also creates beneficial derivatives such as indoles and secondary bile acids. The breakdown of β-(1,3)-glucan is facilitated by microbiota enzymes like β-(1,3)-glucosidase and β-(1,3)glucanase, while β-(1,6)-linked structures are broken down by β-(1,6)-glucanase. These enzymes ensure nutrient availability and promote immune balance.

Studies in animals and humans show that β-glucan intake improves body mass, antioxidant activity, and reduces inflammation. A clinical trial involving 52 adult participants demonstrated that daily intake of 0.75 g of barley β-glucan for 30 days is safe and significantly increases the number of bifidobacteria.

Stability of β-glucan in the GIT

β-glucan is a highly polar macromolecule with a large molecular weight, which prevents its transmembrane transfer by passive diffusion. After oral administration, β-glucan passes through the gastrointestinal tract without significant degradation – it is resistant to the hydrolytic action of enzymes present in saliva, gastric juice, and small intestine enzymes. However, in the colon, β-glucan undergoes fermentation by the gut microbiota, where it is broken down into short-chain fatty acids (SCFAs), including acetic, propionic, and butyric acids, which are key metabolites of microbial fermentation.

Due to its molecular architecture, which lacks substrate sites for the action of human digestive enzymes, β-glucan demonstrates high stability in the gastrointestinal environment, highlighting its potential as a candidate for targeted colonic delivery of bioactive compounds. Furthermore, in vivo studies suggest that orally administered β-glucan is biologically active and comparable to its parenteral forms. Experimental data show that, three days after the oral administration of labeled β-glucan (in soluble or

particulate form), the signal is detected in the macrophages of the spleen, and the size of the ingested β-glucan corresponds to the initial molecular form. These findings suggest that phagocytosed β-glucan undergoes slow intracellular degradation, gradually releasing soluble, biologically active fragments that may act on surrounding cells. Complete degradation of β-glucan by macrophages is estimated to take approximately thirteen days, with macrophages retaining β­glucan in an undegraded state for the first four days, followed by gradual fragmentation into less soluble components.

Effect of β-glucan on health conditions

Regulation of metabolic syndrome - Metabolic syndrome encompasses a group of interrelated metabolic disorders, including abdominal obesity, atherosclerosis, low HDL cholesterol levels, glucose intolerance, elevated blood pressure, and insulin resistance. Cereal β-glucans (CBG), particularly those from oats and barley, have demonstrated effectiveness as dietary fibers in improving key metabolic parameters such as dyslipidemia and insulin resistance, along with additional antioxidant effects through the elimination of reactive oxygen species (ROS) and modulation of the gut microbiota.

The therapeutic effects of CBG are attributed to their unique structure, which includes (1→3)­ and (1→4)­β-D-glucosidic bonds, making them resistant to degradation and absorption in the small intestine. By increasing the viscosity of intestinal content, CBG binds to bile acids, reduces cholesterol and triglyceride absorption, and promotes their elimination. OBG (β-glucans from oats) slow gastric emptying in healthy individuals, leading to a reduced glycemic response and decreased postprandial insulin secretion. In experiments on mice with obesity-induced diets, it has been shown that BBG (barley β-glucans) stimulate the secretion of gut hormones through

fermentation products like short-chain fatty acids (SCFAs), suppress appetite, and improve insulin sensitivity.

Mechanism of hypoglycemic effect - Diabetes mellitus , a chronic metabolic disease characterized by elevated blood glucose levels, is a significant risk factor for the development of cardiovascular diseases such as hypertension, coronary artery disease, peripheral vascular disease, and atherosclerosis. According to the WHO, the prevalence of type 2 diabetes is rising globally at an alarming rate.

The etiology of the disease involves β-cell dysfunction, insulin resistance, mitochondrial dysfunction, and apoptosis. In this context, β-glucan stands out as a bioactive compound that can modulate postprandial glycemia and insulin activity. β-glucans from cereals, particularly oats and barley, have been extensively studied for their ability to lower blood glucose and cholesterol levels. Barley, a grain with a low glycemic index, shows particularly favorable effects – the addition of 4 g of β-glucan to chapatti reduced the glycemic index from 54 to 30. These effects are the result of the properties of β-glucan as a dietary fiber (DF), which slows gastric emptying and delays glucose absorption. As a dietary fiber, β-glucan is resistant to digestion in the small intestine and reaches the colon, where it undergoes microbial fermentation, producing short-chain fatty acids (SCFAs). SCFAs contribute to the maintenance of intestinal pH homeostasis and mediate the regulation of gastrointestinal hormone secretion, thereby participating in neuroendocrine signaling of satiety.

According to a study, β­glucan shows significant antidiabetic potential, as it was observed to lower glucose, cholesterol, and triglyceride levels in an obese rat model. Furthermore, oat β-glucans demonstrated the ability to inhibit intestinal disaccharidase activity, reducing the glycemic response in a dose­dependent manner, as confirmed in both in vivo and in vitro conditions. These effects are attributed to the viscous structure of the β-glucan gel, whose viscosity is inversely proportional to the postprandial rise in blood glucose.

Mechanism and effect of cholesterol loweringDyslipidemia, a condition characterized by elevated lipid levels in the blood, is a significant risk factor for the development of cardiovascular diseases, including myocardial infarction, stroke, and atherosclerosis. Given its high prevalence – with 11.7% of adults in

the US having total cholesterol levels greater than 240 mg/dL – it is essential to explore effective therapeutic strategies.

β-glucan has emerged as a promising hypolipidemic agent that works through multiple mechanisms: it lowers cholesterol, increases the production of short-chain fatty acids (SCFAs), promotes the growth of beneficial microbiota, and contributes to colon health. The primary mechanism of β-glucan involves binding bile acids, thereby promoting their elimination through feces and consequently reducing cholesterol and bile acids in the plasma. Increased excretion of bile acids stimulates their re-synthesis in the liver, which activates cholesterol catabolism and reduces lipid absorption, further contributing to the reduction of plasma cholesterol levels. In addition, fermentation of β-glucan in the colon produces acetate and butyrate, which inhibit cholesterol synthesis. Moreover, the viscosity of the β-glucan gel slows the absorption of fats and cholesterol in the digestive system.

Clinical trials have shown that a daily intake of 3 g of β­glucan significantly reduces LDL cholesterol (~10–15%), without affecting HDL. Additionally, the high viscosity of β-glucan plays an important role in modulating the absorption of cholesterol, fats, and other biomolecules in the gastrointestinal tract, by increasing content density and slowing digestion. Similar effects are confirmed by a meta­analysis of 14 studies on barley β-glucan. Based on the available evidence, the FDA has approved health claims regarding the effect of β-glucans (oats, psyllium) on lowering blood cholesterol.

Application of β-glucan

In recent years, β­glucan has gained significant attention for its application in the food, medical, and cosmetic industries. In food science, it is used as a functional ingredient that improves the texture, stability, and nutritional value of products. Due to its immunomodulatory properties, β-glucan stands out in medicine, offering potential therapeutic benefits for diseases such as cardiovascular conditions and diabetes. In cosmetics, it is used for soothing and hydrating the skin, providing natural and effective care. The versatility of β-glucan makes it a key resource for innovation across various industrial sectors.

Application in the food and beverage industryβ-glucan is a high-molecular polysaccharide known for its gelling, thickening, and emulsifying properties, which contribute to the texture, stability, and nutritional profile of food and beverages. In culinary applications, it is used as a fat replacer and a source of soluble fiber, particularly in low­calorie formulations. Its application spans a range of food products, including ice creams, sauces, meat emulsions, fermented dairy products, and bread. However, the technological application of β-glucan is limited by its high viscosity, complex handling, and unfavorable rheological properties in industrial processes.

Recent research highlights its potential as a functional ingredient in bread enriched with resistant starch and folates, as well as in dairy products with reduced caloric value. Special attention is given to its prebiotic effects and potential for encapsulating bioactive substances. The concentration of β-glu-

can in food products varies significantly (0.3–20%), depending on the matrix and processing technology, with the addition affecting rheological and sensory properties, including hardness, cohesion, and elasticity.

Although β­glucan has been shown to effectively improve the nutritional quality, texture, and stability of products, optimal formulations and technological strategies for its incorporation still require further research. It is particularly important to investigate its behavior at different concentrations, interactions with proteins and other hydrocolloids, and its impact on the gut microbiota. Additionally, it is crucial to optimize sensory-acceptable formulations to ensure consumer acceptance and long-term health benefits.

Application of β-glucan in the cosmetic industry - β-glucan, a polysaccharide naturally found in fungi, cereals, and microorganisms, has gained widespread use in the cosmetic industry due to its numerous bioactive properties. Scientific research shows that β-glucan possesses soothing, moisturizing, and anti­irritant properties, making it highly beneficial for skin care. Its ability to regenerate the skin and retain moisture makes it effective in improving skin and mucosal hydration, contributing to revitalization and the maintenance of optimal skin condition. Additionally, β-glucan is used in cosmetic formulations to improve skin health, including treatments for reducing signs of aging, such as fine lines and wrinkles caused by oxidative damage. Research suggests that β-glucan can help stimulate collagen production, resulting in reduced fine lines and alleviation of conditions such as eczema. Furthermore, β­glucan has been shown to be effective in wound healing, and studies also suggest its potential use in wound dressings in combination with chitosan. Due to its moisturizing properties, β-glucan from various sources, such as yeast and oats (e.g., "Avenacare"), is utilized in cosmetics and personal care products. Its efficacy in stimulating keratinocyte growth and protecting the skin from detergent-induced damage further demonstrates its versatility.

Application of β-glucan in the medical industry - β-glucans have become key compounds in the medical industry, with significant potential for the therapy and treatment of various diseases. Clinical trials from the 1980s marked the beginning of the use of fungal β-glucans as adjunctive therapy in cancer treatment, opening up possibilities for innovative approaches in medical treatment. β-glucans, such as lentinan, D-fraction, and schizophyllan, have shown strong anticancer effects by inhibiting the proliferation of cancer cells, inducing cytotoxicity, and promoting apoptosis through complex molecular pathways. While cancer remains one of the leading causes of death worldwide, β­glucans offer an alternative to conventional therapies like chemotherapy and radiation, with increasing emphasis on their ability to reduce metastasis and recurrence. In addition to their direct application in cancer treatment, β-glucans possess immunomodulatory properties, which include the activation of NK cells, T cells, and macrophages, enhancing the immune response to tumor cells. Furthermore, research has

shown that β-glucans can improve phagocytosis and the release of IL-2, helping to control growth. β-glucans are also promising in the treatment of infections, including COVID-19, where they have shown the ability to reduce disease symptoms and improve the immune response to SARS-CoV-2.

The effects of β-glucans in the medical industry are not limited to oncology and infections; they also possess the ability to accelerate wound healing through stimulation of macrophage infiltration, collagen synthesis, and skin reepithelialization. Clinical trials have shown that β-glucans can speed up ulcer healing, with clinical results showing a significant advantage over the control group. Additionally, βglucans have been associated with lowering LDL cholesterol levels, and their role in regulating bile acid metabolism may play an important role in the prevention of cardiovascular diseases.

Conclusion

β-glucan is a natural polysaccharide with pronounced bioactive properties—immunomodulatory, antitumor, prebiotic, and metabolic protective. Its resistance to digestion enables fermentation in the large intestine, producing beneficial metabolites that support the gut microbiota, immune balance, and epithelial barrier. It promotes the growth of beneficial bacteria such as Lactobacillus and Bifidobacterium

It also plays a crucial role in the regulation of metabolic syndrome through its hypoglycemic (reduced glucose absorption) and hypolipidemic effects (lowering LDL cholesterol and triglycerides), particularly with a daily intake of ≥3 g of β-glucan. Additionally, its ability to modulate the tumor microenvironment makes it a promising candidate for cancer immunotherapy.

Due to these properties, β­glucan finds widespread use in the food, medical, and cosmetic industries ­ as a functional fiber, immunostimulant, wound healing agent, and skin regeneration promoter. However, further research is needed to optimize its application and formulations in various fields.

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35 TH Gamel, E-SM Abdel-Aal, N Ames, R Duss, SM Tosh (2014). Enzymatic extraction of beta-glucan from oat bran cereals and oat crackers and optimization of viscosity measurement. J. Cereal Sci., 59, pp. 33-40.

36 S Chakraborty, VD Rajeswari (2022) Biomedical aspects of beta-glucan on glucose metabolism and its role on primary gene PIK3R1. J. Funct. Foods. 99, 105296.

37 PS Thondre, CJK Henry (2009). High-molecular-weight barley β­glucan in chapatis (unleavened Indian flatbread) lowers glycemic index. Nutr. Res. 29, 480–486.

38 RV Lobato, VO Silva, EF Andrade, DR Orlando, MG Zangeronimo, RV de Souza, LJ Pereira (2015). Metabolic effects of β-glucans (Saccharomyces cerevisae) per os administration in rats with streptozotocin-induced diabetes. Nutr. Hosp. 32, 256–264.

39 EJ Benjamin, P Muntner, A Alonso, MS Bittencourt, CW Callaway, AP Carson, A.M Chamberlain, AR Chang, S Cheng, SR Das, et al. (2019). Heart disease and stroke statistics—2019 update: A report from the American Heart Association. Circulation. 139, e56–e528.

40D Kumar, S Narwal, S Virani, RPS Verma, S Gyawali, GP Singh (2020). Barley grain beta glucan enrichment: Status and opportunities. In Wheat and Barley Grain Biofortification; Gupta, O.P., Pandey, V., Narwal, S., Sharma, P., Ram, S., Singh, G.P., Eds.; Woodhead Publishing: Sawston, UK, pp. 295–308.

41 H Zhang, N Zhang, Z Xiong, G Wang, Y Xia, P Lai, L Ai (2018). Structural characterization and rheological properties of β-D-glucan from hull-less barley (Hordeum vulgare L. var. nudum Hook. f.). Phytochemistry. 155, 155–163.

42 P Kittisuban, P Ritthiruangdej, M Suphantharika (2014). Optimization of hydroxypropylmethylcellulose, yeast β-glucan, and whey protein levels based on physical properties of gluten-free rice bread using response surface methodology. LWT-Food Sci. Technol. 57, 738–748.

43 B Du, Z Bian, B Xu (2014). Skin health promotion effects of natural beta-glucan derived from cereals and microorganisms: A review. Phytother. Res. 28, 159–166.

44 H Sung, J Ferlay, RL Siegel, M Laversanne, I Soerjomataram, A Jemal, F Bray (2021). Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 71, 209–249.

45 V Vetvicka, TV Teplyakova, AB Shintyapina, TA Korolenko (2021). Effects of medicinal fungi­derived β-glucan on tumor progression. J. Fungi. 7, 250.

46 J Garcia, F Rodrigues, MJ Saavedra, FM Nunes, G Marques (2022). Bioactive polysaccharides from medicinal mushrooms: A review on their isolation, structural characteristics and antitumor activity. Food Biosci. 49, 101955.

47 EJ Murphy, E Rezoagli, I Major, NJ Rowan, JG Laffey (2020). β-glucan metabolic and immunomodulatory properties and potential for clinical application. J. Fungi. 6, 356.;

48 A Córdova-Martínez, A Caballero-García, E Roche, DC Noriega (2021). β-Glucans could be adjuvants for SARS-CoV-2 virus vaccines (COVID-19). Int. J. Environ. Res. Public Health. 18, 12636.

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COMMITTED TO YOUR EXCELLENCE

Ingood by Olga Presents Sulfodyne® for Women's Health at Vitafoods Europe

Olga’s ingredient division aims to address specific niche markets, such as plant-based solutions for sports nutrition or women’s health, in line with the hypersegmentation trend seen in the nutrition and nutraceutical markets.

For this new edition of Vitafoods Europe, Ingood by Olga continues to innovate to offer solutions combining health benefits, nutrition, plant-based ingredients, and accessibility. Olga’s ingredient division aims to address specific niche markets, such as plant-based solutions for sports nutrition or women’s health, in line with the hypersegmentation trend seen in the nutrition and nutraceutical markets.

New real-life study on women’s health

A new real­life study on 50 women confirms the effectiveness of Sulfodyne®, the unique and authentic form of natural and active sulforaphane in managing premenstrual syndrome (PMS).

• Women’s health: a segment in need of solutions 1 in 2 women suffers from menstrual pain1. However, there are no real solutions available on the market to address these symptoms. With 8 out of 10 dietary supplements purchased by women in France, the women’s health market is more than an opportunity, it is a segment in need of solutions2. Women’s health is large and covering many symptoms or life stages that have long been ignored by medical research, many of which are linked to an uncontrolled inflammatory process. The role of sulforaphane, particularly through the activation of Nrf2, is gaining interest in managing certain women’s health issues, such as premenstrual syndrome (PMS).

• Premenstrual syndrome: so common and yet so poorly understood

PMS affects between 30% and 50% of women3,4,5 PMS symptoms are both physical (bloating, headaches, pain, etc.) and psychological (mood swings, anxiety, depression, etc.). They appear 1 to 2 weeks before menstruation, subside with the onset of menstruation, and are cyclical and recurrent.

Recently, a mechanism of action involved in PMS development has been identified: oxidative stress and chronic inflammation, observed through the presence of specific biomarkers associated with these two mechanisms in women with PMS symptoms6,7. For instance, a study on women with PMS showed a correlation between high levels of inflammatory factors (IL-2, IL-4, IL-10, and IL-12) and total PMS symptom scores6. Other inflammatory markers associated with migraines, a common PMS symptom, such as TNF-α, CRP, and IL-6, are also elevated in women with PMS6. Another study showed that women with PMS had higher levels of oxidative stress markers, such as ROS, which can damage to neuronal cells and cause mood changes7

Effective for PMS management

Sulforaphane has well-documented antioxidant and anti­inflammatory properties in scientific literature, notably through the activation of Nrf2, which reduces certain oxidative stress markers like ROS, as well as pro­inflammatory parameters, reducing and controlling the inflammatory state in various invitro and in vivo models8,9,10

Recent studies highlight an antidepressant and anxiolytic effect of sulforaphane through Nrf2 activation11,12. Sulforaphane also has pain-relieving and anti­inflammatory effects in several pain models13,14,15. These effects are explained by a reduction in markers such as IL6, IL-1β, and TNF-α. Sulfodyne®, standardized to 5% sulforaphane, is an excellent candidate for modulating PMS symptoms, particularly by reducing inflammation through pain­relieving and anti­inflammatory effects while providing anxiolytic and antidepressant benefits.

To obtain initial proof of concept, Ingood by Olga conducted a real-life study with Sulfodyne® on 50 healthy women aged between the ages of 20 and 40 suffering from PMS­related symptoms, using a quo-

ta method in France. Over three cycles, participants consumed Sulfodyne® at a dose of 2 x 200 mg per day, 7 days before their periods and during the first 3 days of menstruation.

The study results confirm the effectiveness of Sulfodyne® for PMS management, offering a holistic approach16:

• 84% of women who tested Sulfodyne® reported a reduction in PMS-related discomfort, and more than 9 out of 10 reported an improvement in their emotional state and a reduction in pain.

• 94% of women found it to fast-acting starting from the first cycle.

• 86% of women experienced an improvement in their quality of life.

The study also showed a high recommendation rate and strong purchase intent: 8 out of 10 women would recommend and buy Sulfodyne® .

Unique and authentic active ingredient standardized to 5% stable and active sulforaphane

Sulforaphane is an isothiocyanate naturally found in cruciferous vegetables like broccoli in its precursor and inactive form as glucoraphanin. For sulforaphane to be optimally released and absorbed by the body, glucoraphanin must be converted into its active form by the enzyme myrosinase.

Various broccoli extracts are available on the market, most containing glucoraphanin, often misleadingly labeled as "sulforaphane glucosinolate," which is inactive in this form. Several studies have shown that the bioavailability of sulforaphane after ingesting glucoraphanin is very low, around 10%. While adding myrosinase can improve this bioavailability, it remains limited, around 30%17,18,19

Myrosinase is a sensitive enzyme at acid pH levels that can be inactivated during digestion. The use of gastro-resistant capsules slightly improves the bioavailability of extracts containing glucoraphanin and myrosinase, but it only averages 36%17,19

Sulfodyne® is the only broccoli seed extract that contains sulforaphane in its free, active, and stable form, requiring no conversion, and its 5% standardization is the highest on the global market. Studies confirm that Sulfodyne® provides a sulforaphane bioavailability of 70%17,18, seven times higher. Ingood by Olga aims to educate and raise awareness among market players about the importance of choosing the right source of sulforaphane to ensure optimal bioavailability in the finished product and provide real efficacy to consumers.

In conclusion

Sulfodyne® reduces PMS-related discomfort by acting on both on emotional and physical discomforts, in line with evidence already established from in vivo studies of pain and depression. It meets consumer expectations and contributes to improving the quality of life during PMS. Base on consumer feedback evaluated, Ingood by Olga intends to continue to study the role of Sulfodyne® in PMS management, particularly its mechanisms of action.

References:

1 Étude Ifop, 2021

2 Council for responsible nutrition, consumer survey on dietary supplements, 2018

3 Rezende et al., 2022

4 Tiranini & Nappi, 2022

5 Modzelewski et al., 2024

6 Sultana et al., 2022

7 Azlan et al., 2013

8 Romeo et al.,2024

9 Boddupalli et al., 2012

10 Ruhee & Suzuki, 2024

11 Martin-de-Saavedra et al., 2013

12 Ferreira-Chamorro et al., 2018

13 Liu et al., 2020.

14 Redondo et al., 2017

15 Guadarrama-Enriquez et al., 2023

16 SULFODYNE® real-life study carried out by an independent research institute on 50 women in France in 2024.

17 Fahey et al., 2015

18 Fahey et al., 2016

19 Fahey et al., 2019

Plant-based nutraceuticals and sports nutrition with complementary partners

Ingood by Olga will also present two new concepts with the goal of showcasing new uses for its ingredients at Vitafoods and inspiring actors in the nutrition and nutraceutical sectors:

• Good Super Greens: A powder drink made from 7 supergreens, including Sulfodyne®, which offers a concentrate of benefits: detox, vitality, concentration, digestive wellness, and immune support. Rich in antioxidants and natural vitamins, it provides 15 mg of sulforaphane per serving. This concept presents a new galenic form in which Sulfodyne® could be integrated, beyond capsules and tablets. The concept was formulated with the expertise of Nutrisun, Olga’s nutrition division. Good Clear Protein: A clear, vegan protein drink powder formulated with our pea protein hydrolysate Peptipea®, providing 17.5 g of protein per serving, developed in partnership with Phodé, which leveraged its expertise in custom aromatic solutions to mask the bitterness of the ingredient. With 40% of clear protein powder launches being vegan, this concept highlights a new application of Peptipea® that allows sports nutrition products to be plant- based without compromising on taste or nutritional properties. Peptipea® is a plantbased protein that offers one of the highest protein contents on the market.

Join us at Vitafoods Europe in Barcelona, from May 20th to 22nd at booth 3G136B in the France Pavilion to discover these ingredients!

2 Rue Julien Neveu, 35530 Noyal-sur-Vilaine Bretagne 35530, France T. +33 (0)2 99 04 11 11 www.ingoodbyolga.com/en/

What Can Help for a Calmer and Deeper Sleep?

Almost one-third of the general population has symptoms of insomnia (defined as difficulty falling asleep and/or staying asleep). The use of drugs for insomnia is limited by their tolerability and the increased risk of addiction, morbidity and mortality with long-term use. The search for safe and effective compounds without harmful effects is crucial in this context.

AUTHOR: Daria Šurić, MPharm, univ.spec.pharm.

For a long time, it was believed that sleep is a state of the organism in which most of its functions cease, and the body is completely at rest. Today we know that this is not entirely true, because even though when we close our eyes and fall asleep some processes in the body slow down, others remain surprisingly active. Sleep begins with the activation of an area of the brain called the hypothalamus, where cascading changes occur that induce changes in the body that result in sleep. Nerve cells in the brain reduce alertness and promote sleepiness, while electrical activity in the brain begins to slow. These and other changes that occur as sleep continues to affect nearly every cell in the body.1

In modern society, there is increasing concern about the risks associated with insomnia and lack of sleep. Recent epidemiological data support the opinion that many segments of the adult population are chronically sleep deprived. On the other hand, there are experts who claim that our basic required amount of sleep is about 6 hours during one night, and that we can easily forget more sleep, because it is com-

pletely unnecessary. However, experimental data on the effects of both acute and cumulative partial sleep deprivation (PSD) consistently point out that sleep restriction has significant negative effects on sleepiness, motor and cognitive performance and mood as well as on some metabolic, hormonal and immunological variables.

Given that chronic partial sleep deprivation can have serious, long­term adverse health effects, it should be avoided in the general population. In the short term, the effects of sleep restriction appear to accumulate linearly, while the effects of long­term PSD should be further investigated, as the few available studies are flawed by methodological weaknesses. On the other hand, there is evidence that extending sleep by 2-3 hours beyond the norm brings only marginal benefits to the average individual. Finally, it is underlined that, as large individual differences do exist in the need for sleep, the search for the sleep need may be vain. A somnotypology, taking into account age, gender and the position in both the sleep-alert and the morningness-eveningness continuum, should help in the search for the actual individual sleep need. 2

Insomnia and sleep disorders are considered a major problem worldwide, especially in Western societies. Over a year, the prevalence of general sleep disturbance is estimated at around 85%, and a diagnosis of primary insomnia is estimated to be approximately 10%.9

Insomnia is associated with reduced hippocampal volume, daytime cortical gamma-aminobutyric acid (GABA) levels and activation of the caudate nucleus. In several parts of the brain, such as the hippocampus or the prefrontal cortex, inhibition of the usual decline in activity that occurs during the transition from waking to sleep has been observed. Thus, general overactivity of the arousal, emotion regulation, and cognitive systems probably leads to the pathophysiology of insomnia. For the treatment of this disease, there are effective drugs such as benzodiazepines or benzodiazepine receptor agonists. However, the use of these sleep medications is limited by their tolerance and the increased risk of addiction, morbidity and mortality with long-term use.10 In this context, the search for safe and effective compounds without adverse effects is essential.

The extent to which sleep is causally related to mental health is unclear.

The aim of the 2006 study was to to trace the consequences of insufficient sleep in terms of chronic sleep reduction, rather than acute sleep deprivation on fatigue, mood, cognitive performance self-estimation, and daytime sleepiness in different age­social groups. The age group of the subjects reflected their social situation and the organization of working hours: adolescents followed strict school schedules with starting times often before 8:00 h; university students had more flexible timetables; young employees were engaged in regular morning schedules or irregular daytime hours or day or night shifts. 3

The most frequent complaints of adolescents included tiredness on awakening (46%), nervousness and general weakness. University students reported excessive sleepiness (50%), tension and nervousness. Employees suffered the most from negative moods, such as tension (49%), nervousness and irritability. The findings of the study show that chronic sleep loss seems to affect women more than men. The correlation of fatigue and mood with the need for sleep and the sleep index was more pronounced in younger subjects. Surprisingly, symptoms of fatigue in school children and students were just as common as in hard­working adults. Since the problem of insufficient amount of sleep is already present among young people, it is necessary to pay more attention to the organization of their working time. 3

One way to test the causal link of sleep quality to mental health is to evaluate the extent to which interventions that improve sleep quality also improve mental health. A meta-analysis of randomized controlled trials was conducted, which reported the effects of an intervention that improved sleep on complex mental health and on seven specific mental health problems. 65 trials with 72 interventions and 8,608 participants were included in the meta-analysis. Sleep improvement led to a moderately significant effect on overall mental health, depression, anxiety, and rumination, followed by a small-to-moderately significant effect on stress, and finally a small­significant effect on positive symptoms in psychosis. A cause­and­effect relationship was also clarified, in the sense that greater improvements in sleep quality led to greater improvements in mental health. These findings suggest that sleep quality is causally related to psychological difficulties. Future research might consider how methods that improve sleep quality could be incorporated into services to improve mental health. We should also study the mechanisms that affect mental health by influencing the quality of sleep.4

Problems with sleep are common. A review of several hundred epidemiological studies concluded that nearly one-third of the general population has symptoms of insomnia (defined as difficulty falling asleep and/or staying asleep), between 4% and 26% experience excessive sleepiness, and between 2% and 4% of people experience obstructive sleep apnea.5 Additionally, a recent study with more than 2,000 participants reported that the prevalence of “general sleep disturbances” was 32%. It was previously assumed that mental health difficulties lead to sleep problems, however the reverse may also be true, such that poor sleep contributes to the onset, recurrence,

and maintenance of mental health difficulties. Sleep disorders and stress have been in the top 3 consumer health concerns in recent years.12 According to the Centers for Disease Control and Prevention (CDC), 24 hours of sleep deprivation is equivalent to a blood alcohol concentration of 0.10%. Such a 24-hour lack of sleep can cause numerous symptoms (Table 1).

Taking into account everything that has been stated so far, there is a clear need to find other ways to contribute to the quality and duration of sleep, in addition to classical drug therapy, which has longterm unwanted effects. In addition to adjusting the diet and introducing bedtime routines, dietary supplements play a key role. We will discuss several ingredients below, as they have shown a positive effect on sleep in studies and in practice.

Melatonin

Melatonin is a neurohormone secreted by the pineal gland in the brain, and is well known for causing and regulating sleep. Light suppresses melatonin synthesis. The primary use of melatonin as a dietary supplement is to normalize abnormal sleep patterns. Melatonin may also have general neuroprotective effects related to its antioxidant effects.

There are some demographic groups that tend to have irregular melatonin production in their body. Smokers tend to be less responsive to supplementation, and older people tend to not produce as much during night time. Depression has also been associated with lower melatonin levels.

Very rarely, serious adverse effects resulting from melatonin supplementation (often in very high doses) have been reported. Taking melatonin is not associated with negative feedback (when taking a supplement causes your body to produce less of the hormone). It is also not addictive. Melatonin’s primary mechanism is by helping decrease the time it takes to fall asleep (as a hormone, that's its primary job). Doses between 500 mcg (0.5 mg) and 5 mg of mela-

TABLE 1 Staying awake for 24 hours may cause symptoms like:

drowsiness

irritability

anger

increased risk of stress

decreased alertness

impaired concentration

brain fog

fatigue

tremors

reduced coordination

increased risk of mistakes or accidents

food cravings

puffy eyes

dark undereye circles

tonin appear to be effective in regulating the sleep cycle. It is recommended to start with 500 mcg, then increase the dose to 1 mg if necessary. Higher doses belong to the drug category and should be taken under the supervision of a doctor. The benefits of melatonin are not dose-dependent, as taking more will not help to fall asleep faster.

For help to fall asleep, it is recommended to take melatonin approximately 30 minutes before bedtime.

As part of the study to determine the optimal dose of melatonin, research was conducted on children. It showed that their treatment compared to the general Dutch population14 can be sustained over a long period of time without significant deviation in development, regarding sleep quality, puberty development and mental health scores.

In a multicenter, randomized, placebo-controlled study of 170 ambulatory patients aged 55 years or older, who suffered from primary insomnia, the effects of 2 mg prolonged-release melatonin (PR-melatonin) for 3 weeks were evaluated compared to placebo treatment. It was the first drug shown to significantly improve sleep quality and morning alertness in these patients, suggesting restorative sleep. Also, the patients did not have withdrawal symptoms after discontinuation.15 We emphasize the fact that melatonin in that study belonged to the category of drugs due to the high dose contained.

Here is another study that was conducted to systematically review the effect of melatonin on sleep quality. Evidence from randomized clinical trials (RCTs) investigating the effects of melatonin on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in adults with various diseases is summarized. According to this index, it was determined that treatment with exogenous melatonin has positive effects on the quality of sleep in adults.7

In order to overcome the short­term effect of melatonin on easier falling asleep and to prevent late night awakenings, some manufacturers have developed a unique form of micronized melatonin that enables both immediate and prolonged release, thus comprehensively improving the quality of sleep.

In most European countries where melatonin is al-

Melatonin contributes to the alleviation of subjective feelings of jet lag.

1698/1780/4080 Melatonin contributes to the reduction of time taken to fall asleep.

Conditions of use: the claim may be used only for food which contains at least 0,5 mg of melatonin per quantified portion. Information to the consumer: the beneficial effect is obtained with a minimum intake of 0,5 mg to be taken close to bedtime on the first day of travel and on the following few days after arrival at the destination.

Conditions of use: the claim may be used only for food which contains 1 mg of melatonin per quantified portion. Information to the consumer: the beneficial effect is obtained by consuming 1 mg of melatonin close to bedtime.

lowed as an ingredient in food supplements (including Croatia), the maximum dose is 1 mg per day (Table 2). It is different in Turkey, where the content of melatonin is allowed up to 3 mg for adults, but with a mandatory warning on the declaration:"It should not be used by pregnant or breastfeeding women and persons under 18 years of age", "Do not drive, operate machinery or consume alcohol while using this product", "It should not be used for more than two months". Germany, Ireland, Iceland and Slovenia do not allow melatonin in food supplements, but classify it as a drug, regardless of dosage.

Saffron, Crocus sativus L.

The saffron extract used in food supplements is among the most expensive extracts, just as the spice used in food preparation is among the most expensive spices. But there is a valid reason for that.

Saffron belongs to the iris family. Its threads located in the center of the purple flower are stigmas (Figure 1). There are only three orange-yellow stigmas in each flower, which means that it takes many flowers to produce a small amount of extract or spice. Each kilogram of saffron contains between 15 and 20 thousand stigmas. If you were to grow saffron yourself, you would need 75 thousand flowers to get half a kilogram.

But that is not the only reason why saffron is so expensive. Saffron flowers are very delicate, and the only way to properly remove the threads is to tear them off by hand. The flower is so delicate that if the saffron threads are not harvested soon after the flowers bloom, they will wilt and become unusable. It takes about 370 to 470 hours of work to harvest one kilogram of saffron. However, if we consider that sleep and the quality of sleep are of inestimable importance for human health, then the price of saffron extract is a justified investment.

The dried stigmas of the saffron plant (Figure 2) used in traditional medicine, and the compounds it contains - safranal, crocin and crocetin - have been largely studied for their effects on depression and anxiety in humans.5 Additionally, saffron appears to have beneficial effects on sleep duration and quality, as evidenced by previous reports using different approaches and protocols. Some studies used a whole saffron extract, while others examined the effects of its active compound crocetin.

It is undeniable that saffron extract is effective in the context of depression and anxiety, but its effect on sleep quality has not been investigated by objective approaches until recently. For this purpose, a randomized, double-blind, placebo controlled study was conducted in subjects presenting mild to moderate sleep disorder associated with anxiety. Sixty-six subjects were randomized and supplemented with a placebo (maltodextrin) or a saffron extract (15.5 mg per day) for 6 weeks.8

Saffron extract intake was associated with improvements in sleep quality in adults with self-reported sleep complaints. Further studies using larger samples sizes, treatment periods, objective outcome measures, and volunteers with varying demographic and psychographic characteristics are required to replicate and extend these findings.16

In conclusion, the above studies provide evidence that saffron extract could be an interesting natural

TABLE 2 Health claims for melatonin (EFSA)

and safe strategy to improve sleep duration and quality of sleep on population presented mild to moderate chronic primary sleep disorder.

Biopeptides from milk

Developed in France, Lactium is the generic name of bioactive milk-derived peptides. They are amino acid chains concentrated from casein, derived from cow milk, that act on GABA receptors.

However, its discovery was ultimately thanks to babies. The enzymes present in babies’ digestive systems are responsible for the release of this bioactive peptide resulting in a state of bliss. The digestive enzyme system of adults is no longer capable of releasing this bioactive milk peptide. After many years of work, researchers have developed an innovative process to reproduce a baby's digestive system. They used the well-known digestive enzyme trypsin to isolate a milk protein hydrolyzate containing the bioactive peptide alpha-casozepine from casein.

Lactium® improves sleep, reduces stress and cortisol levels while inducing relaxation and improving mental function. (Clare&Swaisgood,2000;Delini-Stula & Holsboer-Trachsler, 2009; de Saint-Hilaire, Messaoudi, Desor, & Kobayashi, 2009) . It is an effective alternative to medication for anxiety and insomnia.

The study evaluated the effects of alpha­s1 casein hydrolyzate (ACH) on the subjective and objective sleep profiles in subjects with poor sleep quality. A double-blind, randomized, cross-over trial was conducted with 48 participants (49.0 ± 1.7 years, 65% female) who exhibited a mild to moderate degree of sleep disturbance. During the first four weeks, they received either ACH or placebo, and the counterpart was administered in precisely the same way after a four-week washout period. Findings suggest that refined ACH is well tolerated and may improve sleep quality, with possible cumulative beneficial effects with long-term administration.17

Lactium® can be used as an ingredient in a wide range of products, in capsules, tablets, powders, chewing gums, drinks, as an stand alone active substance or in combination with other ingredients.

Magnesium

Magnesium is found in many food supplements as an independent ingredient, or in combination with other active ingredients for numerous purposes. It is often found in food supplements that are intended to promote healthy sleep. The reason for this is justified. Namely, magnesium plays a role in supporting deep, restorative sleep by maintaining healthy levels of GABA, the neurotransmitter that promotes sleep. Research shows that supplemental magnesium intake can improve sleep quality, especially in people with poor sleep.

There are many other ingredients that offer promising results in improving sleep quality. One of them is DailyZz by Kemin, a clinically tested combination of ingredients for natural sleep support. Clinical data supported by rigorous testing of 100 healthy participants with occasional sleep problems showed that the ingredient can help improve sleep quality, support healthy sleep and improve an individual's functioning during the following day.

One of the interesting new findings is that sleep

fragmentation and short sleep duration are associated with intestinal dysbiosis, a fact that will surely gain importance in the future. It was also found that the addition of probiotics improves the subjective quality of sleep. The quality and duration of sleep can be an important goal for maintaining a healthy gut microbiota composition, but the cyclical nature of this relationship should not be overlooked.18

References:

1 https://thesleepdoctor.com/how-sleep-works/what-is-sleep/

2 Ferrara M, De Gennaro L. How much sleep do we need? Sleep Med Rev. 2001 Apr;5(2):155-179. doi: 10.1053/smrv.2000.0138. PMID: 12531052.

3 Oginska H, Pokorski J. Fatigue and mood correlates of sleep length in three age-social groups: School children, students, and employees. Chronobiol Int. 2006;23(6):1317-28. doi: 10.1080/07420520601089349. PMID: 17190716.

4 Scott AJ, Webb TL, Martyn-St James M, Rowse G, Weich S. Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Dec;60:101556. doi: 10.1016/j.smrv.2021.101556. Epub 2021 Sep 23. PMID: 34607184; PMCID: PMC8651630.

5 Ohayon M.M. Epidemiological overview of sleep disorders in the general population. Sleep Med Res. 2011;2(1):1–9.

6 Kerkhof G.A. Epidemiology of sleep and sleep disorders in The Netherlands. Sleep Med. 2017;30:229–239.

7 Fatemeh G, Sajjad M, Niloufar R, Neda S, Leila S, Khadijeh M. Effect of melatonin supplementation on sleep quality: a systematic review and meta-analysis of randomized controlled trials. J Neurol. 2022 Jan;269(1):205-216. doi: 10.1007/s00415-020-10381-w. Epub 2021 Jan 8. PMID: 33417003.

8 Pachikian BD, Copine S, Suchareau M, Deldicque L. Effects of Saffron Extract on Sleep Quality: A Randomized Double­Blind Controlled Clinical Trial. Nutrients. 2021 Apr 27;13(5):1473. doi: 10.3390/nu13051473. PMID: 33925432; PMCID: PMC8145009.

9 Sarris J., Panossian A., Schweitzer I., Stough C., Scholey A. Herbal medicine for depression, anxiety and insomnia: A review of psychopharmacology and clinical evidence. Eur. Neuropsychopharmacol. 2011;21:841–860. doi: 10.1016/j.euroneuro.2011.04.002.

10 Riemann D., Nissen C., Palagini L., Otte A., Perlis M.L., Spiegelhalder K. The neurobiology, investigation, and treatment of chronic insomnia. Lancet Neurol. 2015;14:547–558. doi: 10.1016/ S1474-4422(15)00021-6.

11 Hausenblas H.A., Saha D., Dubyak P.J., Anton S.D. Saffron (Crocus sativus L.) and major depressive disorder: A meta-analysis of randomized clinical trials. J. Integr. Med. 2013;11:377–383. doi: 10.3736/jintegrmed2013056.

12 Euromonitor survey, 2021

13 Luthringer R, Muzet M, Zisapel N, Staner L. The effect of prolonged-release melatonin on sleep measures and psychomotor performance in elderly patients with insomnia. Int Clin Psychopharmacol. 2009 Sep;24(5):239-49. doi: 10.1097/ YIC.0b013e32832e9b08. PMID: 19584739.

14 Van Geijlswijk IM, Mol RH, Egberts TC, Smits MG. Evaluation of sleep, puberty and mental health in children with long-term melatonin treatment for chronic idiopathic childhood sleep onset insomnia. Psychopharmacology (Berl). 2011 Jul;216(1):111-20. doi: 10.1007/s00213-011-2202-y. Epub 2011 Feb 22. PMID: 21340475; PMCID: PMC3111733.

15 Lemoine P, Nir T, Laudon M, Zisapel N. Prolonged-release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects. J Sleep Res. 2007 Dec;16(4):372­80. doi: 10.1111/ j.1365-2869.2007. 00613.x. PMID: 18036082.

16 Lopresti AL, Smith SJ, Metse AP, Drummond PD. Effects of saffron on sleep quality in healthy adults with self-reported poor sleep: a randomized, double-blind, placebo-controlled trial. J Clin Sleep Med. 2020;16(6):937–947.

17 Kim HJ, Kim J, Lee S, Kim B, Kwon E, Lee JE, Chun MY, Lee CY, Boulier A, Oh S, Lee HW. A Double-Blind, Randomized, Placebo-Controlled Crossover Clinical Study of the Effects of Alpha­s1 Casein Hydrolysate on Sleep Disturbance. Nutrients. 2019 Jun 27;11(7):1466. doi: 10.3390/nu11071466. PMID: 31252661; PMCID: PMC6682925.

18 Matenchuk, Brittany & Mandhane, Piush & Kozyrskyj, Anita. (2020). Sleep, Circadian Rhythm, and Gut Microbiota. Sleep Medicine Reviews. 53. 101340. 10.1016/j.smrv.2020.101340.

Melatonin: Beyond Sleep – A Multifunctional Hormone with Expanding Therapeutic Potential

Melatonin, a hormone primarily produced by the pineal gland and also synthesized in various body tissues, plays a vital role in regulating sleep, circadian rhythms, and overall cellular balance, while exhibiting potent antioxidant properties. Recent research highlights its expanding therapeutic potential, including use in managing GERD, supporting gastrointestinal and immune function, and its highly variable pharmacokinetics depending on age, dosage, and formulation.

AUTHOR: Daria Šurić, MPharm, univ.spec.pharm.

Melatonin, a close derivative of serotonin (5-hydroxytryptamine, 5-HT), is a hormone initiating sleep in humans and a powerful scavenger of free radicals. It is more effective than several well-known vitamins.

In the recent decade, particular research attention has been drawn to a wide range of melatonin’s biological activities and its role in cellular activity, as well as the regulation of intercellular and intersystem relationships. This provides consistency to the body’s internal environment and its protection during interaction with the changing external environment.

Melatonin is produced in the pineal gland. It is also produced in the gastrointestinal tract, brain, liver, kidney, adrenal gland, heart, thymus, genital glands, placenta, uterus, platelets, eosinophilic leukocytes, natural killer cells and other immune system cells (Figure 1).

The remarkable feature of the pineal gland mela-

tonin is its rhythmic synthesis with a peak at the darkphase and lowest at the light-phase in synchronisation with the seasonal environmental light–dark (LD) cycle.

Melatonin produced by enterochromaffin cells of the gastrointestinal mucosa is released into blood vessels or, through diffusion, reaches the outer layers of smooth muscles, where it acts as an antagonist of serotonin contractile effects, causing relaxation. It regulates the transmembrane transport of electrolytes and ions, water content in the intestine, and mitotic activity

However, compared to the melatonin rhythm in the pineal gland, the melatonin profiles in gut tissue displayed a daily rhythm in parallel with the feeding cycle of the carp, irrespective of LD conditions of the environment1. A part of blood melatonin has a source in the digestive system, especially during daytime4

Taken from: Kvetnoy,I.;Ivanov,D.;Mironova,E.;Evsyukova,I.;Nasyrov,R.;Kvetnaia,T.;Polyakova,V.MelatoninastheCornerstoneofNeuroimmunoendocrinology.Int.J.Mol.Sci.2022,23,1835.https://doi.org/10.3390/ijms23031835

Melatonin is best known as a sleep-regulating hormone, but there's growing interest in its potential benefits for gastroesophageal reflux disease (GERD) as well.

From the results of the study from 2010, it can be concluded that melatonin could be used in the treatment of GERD either alone or in combination with omeprazole. The combination therapy of both melatonin and omeprazole is preferable as melatonin accelerates the healing effect of omeprazole and therefore shortens the duration of treatment and minimizes its side effects2. Another clinical study showed that combining melatonin with other natural substances (like tryptophan, B vitamins, and betaine) improved GERD symptoms and, in some cases, worked comparably to omeprazole, a common proton pump inhibitor (PPI)3

The pharmacokinetics, bioavailability and half-life

Melatonins unique amphiphilic nature, stemming from its high lipid and water solubility, facilitates its easy diffusion across biological membranes, including the blood-brain barrier, enabling it to exert its effects throughout the body. The timing of melatonin secretion is orchestrated by the suprachiasmatic nucleus, with its levels rising shortly after the onset of darkness, peaking in the middle of the night, and gradually declining during the second half of the night5. This nocturnal surge of melatonin is critical for promoting sleep and synchronizing the body's internal clock with the external environment. Due to the discovery of melatonin synthesis in endocrine organs, neural structures, and immunocom-

petent cells, there has been an evolution of new approaches to the unified signal regulation of homeostasis1. The bioavailability of melatonin, however, is subject to considerable inter-individual variability, with oral administration resulting in relatively low and inconsistent absorption rates, which could be due to first­pass metabolism in the liver and significant variation in the melatonin content of marketed preparations6,7

Exogenous melatonin has been well studied as pharmacotherapy for insomnia and circadian rhythm disorders in adults. It is taken orally and has oral bioavailability of 15% due to extensive first­pass metabolism, though this is highly variable, up to 37%. When prescribed as a hypnotic, it is usually taken 30 minutes before bedtime and is available as immediate, slow-release or a combined formulation. Several melatonin formulations are available, including extended-release, immediate-release, and combined immediate and extended-release. Melatonin has demonstrated substantial variability in bioavailability, primarily due to first­pass metabolism and poor absorption. Absorption is also affected by food. Studies in healthy adults have reported bioavailability ranging from 1% to 37%. Food delays the absorption of melatonin, with the time to peak concentration increasing from 0.75 hours in a fasted state to 3 hours when taken with food. Peak concentrations after oral administration have been reported as substantially higher in older adults, up to 240% greater than in adults under the age of 45 years. Other studies have found lower peak serum concentrations but approximately 50% higher mean concentrations with greater variability in those aged 50 years and above. It is reasonable to expect that the

FIGURE 1 Melatonin localization in the human body. The figure illustrates the unique property of melatonin to have the most widespread localization in the human body, being synthesized in various organs.

same dose administered to an older individual would have more pronounced effects. Combined with the variation in bioavailability, there is a compounded risk of unpredictable serum concentration. This may result in increased variability and risk of other adverse effects in older adults8

Melatonin is metabolized by the liver via the cytochrome-P450 enzymes CYP1A1, CYP1A2 and CYP2C19 enzymes to form 6­hydroxymelatonin and is finally excreted as 6-glucuronylmelatonin and 6-hydroxymelatonin via the kidneys. Clearance of melatonin is reduced in the presence of liver disease, although most research has been in cirrhotic patients. There is little evidence of the effects of chronic liver disease on melatonin metabolism in older adults.

The pharmacokinetic profile of melatonin is characterized by rapid absorption, distribution, and elimination.

The majority of melatonin consumption in the US and a substantial proportion in Europe is in the form of a dietary supplement.

How exogenous melatonin affects natural melatonin production

The action of exogenous melatonin on endogenous release of melatonin is complex and is governed by several factors like dosage, timing, and duration of the supplement, as well as inherent factors such as age, genetic factors, and prior medical illness. Exogenous administration of melatonin may potentially suppress the endogenous release by way of feedback inhibition. While some studies suggest that long or high-dose melatonin supplementations may lead to blunting of the endogenous melatonin response, the data are not conclusive and need further investigation. The complex feedback mechanisms of the human organism, mediated by the suprachiasmatic nucleus, are set to obtain homeostasis and prevent excessive hormonal fluctuations. It is still not known whether long-term exogenous melatonin administration resets these feedback mechanisms, thus reducing the pineal gland's capacity to synthesize melatonin on its own. Existing literature presents a variable picture with some reporting no relevant impact on secretion of endogenous melatonin following short-term treatment, while others report short-term suppression, particularly with high doses or extended duration. Furthermore, the patient response to melatonin supplementation provides a further challenge to the investigation.

The pineal gland sensitivity to exogenous melatonin might differ between people and influence the extent of endogenous production suppression. Genetic polymorphisms for melatonin receptors and enzymes metabolizing melatonin might be behind this inter-person variability. The reaction to exogenous melatonin is also influenced by such factors as health status and age. Elderly individuals have their endogenous melatonin production decline, so they are more susceptible to the effect of exogenous supplementation on their already compromised melatonin levels.

Origin of melatonin in supplements

The majority of melatonin in supplements is of synthetic origin. Virtually all of the melatonin avail-

able in the marketplace is laboratory made, which provides high purity, uniform dosing, and no animal contaminants. This form is typically simply called "melatonin" and is most popularly used since it is safe and predictable.

In the recent years, plant melatonin, or phytomelatonin, has gained popularity, particularly with consumers that prefer natural or vegan options. Phytomelatonin is that which is obtained from plants such as rice, tart cherries, alfalfa, or certain herbs such as feverfew and St. John's wort. These types of products are usually so labeled and are what consumers who prefer plant options tend to use.

Historically, melatonin has been obtained from the pineal glands of animals, mostly cows. However, this animal-derived form is no longer practiced because of medical problems, such as the transmission of diseases such as bovine spongiform encephalopathy (mad cow disease), and ethical factors. In many locations, the use of animal-derived melatonin in supplements is prohibited or restricted.

Melatonin supplements many times have additives included that aim to induce sleeping, like magnesium, L-theanine, valerian root, or chamomile, while the actual melatonin still remains the main active ingredient.

Conclusion

Melatonin is far more than just a sleep aid - it is a multifuctional hormone with widespread production throughout the body and a growing body of research supporting its roles in gastrointestinal health, immune modulation, neuroendocrine balance, and antioxidant defense. As our understanding deepens, melatonin continues to emerge as a promising therapeutic agent, warranting further exploration in both clinical and supplemental applications.

References:

1 Kvetnoy, I.; Ivanov, D.; Mironova, E.; Evsyukova, I.; Nasyrov, R.; Kvetnaia, T.; Polyakova, V. Melatonin as the Cornerstone of Neuroimmunoendocrinology. Int. J. Mol. Sci. 2022, 23, 1835. https://doi.org/10.3390/ijms23031835

2 Kandil, T. S., Mousa, A. A., El-Gendy, A. A., & Abbas, A. M. (2010). The potential therapeutic effect of melatonin in Gastro­Esophageal Reflux Disease. BMC gastroenterology, 10, 7. https://doi.org/10.1186/1471-230X-10-7

3 Pereira R.deS. (2006). Regression of gastroesophageal reflux disease symptoms using dietary supplementation with melatonin, vitamins and aminoacids: comparison with omeprazole. Journal of pineal research, 41(3), 195–200. https://doi.org/10.1111/j.1600-079X.2006.00359.x

4 Lemoine, P., Garfinkel, D., Laudon, M., Nir, T., & Zisapel, N. (2011). Prolonged-release melatonin for insomnia - an open-label long-term study of efficacy, safety, and withdrawal. Therapeutics and clinical risk management, 7, 301–311. https://doi.org/10.2147/TCRM.S23036

5 Zee, P. C., Attarian, H., & Videnovic, A. (2013). Circadian rhythm abnormalities. Continuum (Minneapolis, Minn.), 19(1 Sleep Disorders), 132–147. https://doi.org/10.1212/01.CON.0000427209.21177.aa

6 Tuft C, Matar E, Menczel Schrire Z, Grunstein RR, Yee BJ, Hoyos CM. Current Insights into the Risks of Using Melatonin as a Treatment for Sleep Disorders in Older Adults. Clin Interv Aging. 2023;18:4959 https://doi.org/10.2147/CIA.S361519

7 Kvetnoy, I.; Ivanov, D.; Mironova, E.; Evsyukova, I.; Nasyrov, R.; Kvetnaia, T.; Polyakova, V. Melatonin as the Cornerstone of Neuroimmunoendocrinology. Int. J. Mol. Sci. 2022, 23, 1835. https://doi.org/10.3390/ijms23031835

8 Givler, D.; Givler, A.; Luther, P.M.; Wenger, D.M.; Ahmadzadeh, S.; Shekoohi, S.; Edinoff, A.N.; Dorius, B.K.; Jean Baptiste, C.; Cornett, E.M.; et al. Chronic Administration of Melatonin: Physiological and Clinical Considerations. Neurol. Int. 2023, 15, 518-533. https://doi.org/10.3390/neurolint15010031

lnflamrnation in the body can result from physical or athletic exertion. And while a crucial and useful biologica I proces�, such chronic respon�es can damage tissue and cause injuries, leading to various conditions. Because it's composed exclusively of THC s - the major active metabolites of curcumin - C3 Reduct ® delivers anti-inflammatory properties that hold significant promises in protecting and soothing joints and muscles.

formulating product guide :

GLP-1: The Buzzword in Food Supplements –Implications for the Industry

GLP-1 is no longer just a pharmaceutical term - it has become a defining concept in the next generation of metabolic health supplements. As consumer interest surges and science evolves, the supplement industry must balance innovation with credibility to meet the growing demand for natural solutions that support GLP-1 pathways and complement GLP-1 drug use.

In the continuously developing nutraceuticals world, GLP-1 has quickly become a top-of-theagenda topic among the most controversial subjects, transitioning from clinical to mass-market consumer interest. Glucagon-like peptide-1 (GLP-1), an incretin hormone hailed for its central role in glycemic control and appetite inhibition, is here to stay, fueling innovation, investment, and R&D throughout the food supplement industry.

This revival is largely driven by the substantial publicity surrounding GLP-1 receptor agonists like semaglutide and liraglutide, which have shown dramatic weight loss and effective type 2 diabetes treatment outcomes. As consumer awareness of the metabolic impacts of GLP-1 continues to grow, the competition among supplement companies to secure market leadership at the forefront of a category poised for significant consumer engagement and future expansion intensifies.

From the product development perspective, the task is to find ingredients that can naturally stimulate or enhance GLP-1 activity and demonstrate it within regulatory limits. Ingredients such as berberine, chromium, inulin, bitter melon, and some probiotic strains are being investigated or repositioned based on new data which suggest their potential to modulate GLP-1 secretion or receptor sensitivity. Also, the convergence of gut microbiome science and metabolic health is underpinning the role of prebiotic fibres and postbiotic metabolites in this conversation.

Compounds and botanicals being researched for their indirect or supportive effect on GLP­1 pathways:

Berberine – a plant alkaloid found in herbs like Berberis aristata , which can increase insulin sensitivity and potentially induce GLP-1 release.

Chromium picolinate – a common addition to blood sugar support supplements, it can enhance insulin activity and influence GLP­1 levels.

Inulin and other prebiotic fibres, in chicory root, Jerusalem artichoke, and agave, increase SCFA production in the intestines, possibly stimulating endogenous release of GLP-1.

Bitter melon extract (Momordica charantia) – utilised in traditional glycemic control, with more recent studies suggesting that it may stimulate GLP-1 pathways.

Probiotics such as Lactobacillus plantarum and Bifidobacterium animalis subsp. lactis – some strains have been studied for maintenance of the gut- brainmetabolic axis and potential GLP-1 stimulation. Fenugreek extract – rich in soluble fibre and galactomannan, with effects on appetite suppression and control of blood sugar related to GLP-1.

Resveratrol – a polyphenolic grape and berry compound under investigation for increased GLP-1 sensitivity and metabolic adaptability.

Ginger extract may delay gastric emptying and alter glucose response by acting, perhaps at the GLP-1 receptors.

Alpha-lipoic acid – renowned insulin-sensitiser and antioxidant with increasingly critical roles to play in supporting metabolic signalling processes.

The convergence of gut microbiome science and metabolic health only reinforces the importance of these and other compounds. For instance, fermentation of dietary fiber in the gut results in the production of short-chain fatty acids (SCFAs), including butyrate and propionate, that have been shown to release GLP-1 in preclinical models.

But, as with all such rapid trends, there's a fine line between opportunity and overextension. There is consumer demand, to be sure, but robust clinical evidence for many of the "GLP-1-supporting" ingredients remains in its infancy or is highly context-specific. Businesses need to tread carefully, not to over­promise or mischaracterise product benefits. Regulator scrutiny will probably tighten, especially in those markets where hormonal claims may fall

into medicinal or therapeutic categories. From a marketing perspective, the GLP-1 story provides an opportunity for more intelligent storytelling, connecting gut health, fullness, weight control, and metabolic health. But, given that the term "GLP1" approaches pharma nomenclature, careful wording and substantiation of claims will be essential to establishing credibility and compliance.

But, like with all quick-developing trends, there is a thin line between opportunity and overreach. There is consumer pull, but substantive clinical backing for most "GLP-1-supporting" ingredients exists in early stages or is highly context-dependent. Firms need to be careful about overstating the case or downplaying the product's worth. Enforcement at the regulatory level will likely be tightened, especially in markets where hormonal marketing comes under medicinal or therapeutic classifications.

In the future, the GLP-1 direction provides a distinct space of differentiation, especially for those businesses investing in science substantiation, precise formulation, and transparent communication. As the lines between nutrition and pharma continue to blur, top brands will be those that can navigate complexity while providing consumers simple, friendly solutions.

New opportunity: supplements to support patients on GLP-1 drugs

A growing number of consumers are using GLP-1 drugs, such as semaglutide, creating a secondary market for supplements that complement, mitigate side effects, or optimise outcomes of these therapies. This opens up a valuable adjacency strategy for the supplement industry.

Key areas of support include:

1. MICRONUTRIENT REPLENISHMENT

Patients on GLP-1 drugs often experience reduced appetite, which can lead to insufficient nutrient intake. Consider formulating with:

• Multivitamins (especially B-complex, vitamin D, vitamin K2);

• Magnesium bisglycinate for muscle and metabolic support;

• Iron and zinc in bioavailable forms for those with reduced red meat intake.

2. GUT & DIGESTIVE COMFORT

GLP­1 drugs frequently cause GI side effects like nausea, bloating, or constipation. Ginger extract and peppermint oil for nausea relief;

• Probiotics + prebiotics to rebalance gut flora;

• Digestive enzymes to improve nutrient absorption and reduce discomfort.

3. MUSCLE MASS MAINTENANCE & PROTEIN SUPPORT

Weight loss from GLP-1 drugs often includes lean mass loss.

• Whey protein isolate, pea protein, or collagen peptides to support muscle preservation; Branched-chain amino acids (BCAAs) or leucine for anabolic signaling.

4. ENERGY & METABOLIC RESILIENCE

Reduced caloric intake may lead to fatigue or mood fluctuations.

• CoQ10 and alpha-lipoic acid to support mitochondrial function;

Adaptogens (ashwagandha, rhodiola) for adrenal balance;

• L-carnitine to aid fat metabolism.

5. SKIN AND HAIR HEALTH

Rapid weight loss can sometimes impact skin elasticity and hair density.

• Biotin, silica, marine collagen, and hyaluronic acid for cosmetic support;

Antioxidants (vitamin C, astaxanthin, polyphenols) to fight oxidative stress.

These products should be marketed with careful messaging, focusing on supporting wellness during weight loss journeys or complementing metabolic health strategies, rather than directly modifying drug action.

Strategic considerations for brands

While the GLP-1 wave presents exciting opportunities, brands should tread carefully with language and claims. Words like “GLP-1 boost” or “mimics GLP1” may trigger regulatory red flags. Instead, framing around “supporting satiety,” “metabolic health,” “appetite management,” or “gut-brain axis modulation” provides safer ground while still appealing to consumer curiosity.

Formulas that support users of GLP-1 drugs can be a powerful entry point for both legacy supplement brands and drug newcomers aiming to provide meaningful adjuncts in a booming pharmaceutical category.

Conclusion

GLP-1 is more than a buzzword - it’s a lens through which the next generation of weight management and metabolic wellness supplements will be developed. For supplement industry leaders, the opportunity lies not only in mimicking GLP­1 effects with natural ingredients but also in building intelligent, targeted solutions that align with the realities of today’s GLP-1 patient population. Whether you're reformulating for synergy or creating new protocols, the future belongs to science-backed, consumeraligned innovation.

Darmell Ltd.

20+ years of experience in developing new concepts for food supplements

Mob: + 385 91 68 12 444 darmell@protonmail.com www.dar-mell.com

Optimizing Men's Health: Exploring the Science Behind Supplements

Low testosterone, benign prostatic hyperplasia (BPH), erectile dysfunction (ED) are some of the most common men's health problems. While some supplements show promise in improving certain aspects of men's health, cautious use and consultation with healthcare providers are crucial due to limited scientific evidence.

AUTHOR: Valerija Pandža, MPharm

Men's health is a field that focuses on health issues that are most relevant to men, including testosterone levels, testicular health, sperm quality and production, and prostate health. Some of the major conditions that fall under the umbrella of men's health include low testosterone (hypogonadism), sexual dysfunction, infertility, and benign prostatic hyperplasia (BPH).

Low testosterone can have a range of negative effects, including reduced energy levels, depressed mood, difficulty concentrating, and decreased sex drive. BPH and prostate cancer can cause bothersome urinary symptoms, and prostate cancer is the second most common cancer in men worldwide and a leading cause of cancer-related death in men. As such, maintaining healthy testosterone levels and

managing men's health conditions is important for both quality of life and longevity.

The prevalence of these conditions increases with age. For example, studies have shown that about 40% of men experience erectile dysfunction at age 40, increasing to about 70% by age 70. About half of men over 50 have evidence of BPH, which increases to over 80% in men over 70. Testosterone levels decrease by up to 2% per year after age 40. These statistics highlight the importance of addressing men's health concerns as men age.

BPH and nutraceuticals

Benign prostatic hyperplasia (BPH) is a condition where the prostate gland, which is part of the male reproductive system and located below the bladder,

becomes enlarged but not cancerous. This condition is very common in men over 50 years old, with about 50% of men in this age group showing evidence of BPH. The prevalence of BPH increases with age. As the prostate enlarges, the bladder wall thickens and may eventually weaken, leading to lower urinary tract symptoms. However, the correlation between prostate size and symptom severity is inconsistent, and some men with substantially enlarged prostates may experience few symptoms. It is important to note that the symptoms of BPH largely overlap with those of early prostate cancer: a frequent and urgent need to urinate, especially at night, trouble starting a urine stream, a weak or interrupted (i.e., stops and starts several times) urine stream, dribbling at the end of urination, incomplete urination

Patients using food supplements represent a patient population with a keen potential interest and/or adherence to healthy lifestyle changes. Some food supplements and active ingredients have been studied in order to prove their efficacy and safety.

Regardless, more attention should be directed toward heart-healthy lifestyle changes for most urologic men's health conditions, whether they are used in a preventive or synergistic setting with other acceptable clinical treatment options1

During the last decade, phytotherapeutic drugs have gained a more central role in BPH and LUTS management. In particular, clinical usage of the extract of the dried ripe fruit of Serenoa repens with a dosage of 320 mg per day, has shown its clinical efficacy and its superiority. The purpose of the following multicentric observational retrospective study was to evaluate all the urological aspects (clinical, biochemical, instrumental and pathological) of patients affected by BPH and LUTS, with a PSA < 10 ng/ml, a previous negative prostatic biopsy and in therapy with a daily dose of 320/640 mg of Serenoa repens

The study2 was conducted in 8 different centres. Data and information of 298 men with an average of 63 years (mean PSA of 5.4 ng/ml and mean prostate gland volume of 57 cc), affected by non­acute urinary symptoms caused by BPH, a dosed PSA level inferior to 10 ng/ml, a previous negative prostate biopsy and in therapy with Serenoa repens alone or associated to an alpha-blocker, were retrospectively inserted in an extensive on-line SIUrO Database (Societa Italiana di Urologia Oncologica; Italian Society of Oncological Urology).

Results were: PSA levels weren't subjected to an increase, revealing a stabilizing or downward trend. The percentage of patients with PSA below the level

of 4 ng/mL was lower at the end of the study. The overall changes in the uroflowmetry were similar and parallel both in the group with only Serenoa repens intake and in the group with Serenoa repens plus alpha­blocker. The mean medium flow and the mean maximum flow had a slight increase during the observation time. There was a substantial decrease in the number of patients presenting severe prostatic symptoms. Patients reported through the IIEF-5 score a sexual activity substantially unchanged after 6 months of follow-up. The Serenoa repens intake resulted in an improvement of the "inflammatory­like reports", in terms of ultrasound patterns, DRE and bioptical features.

Conclusion of the study was: Serenoa repens demonstrated its efficacy in reducing dysuria with minimal side effects. Further prospective studies might confirm its stabilization or lowering role on PSA levels in this cohort of patients and its possible clinical anti­inflammatory action2

Pygeum (Prunus africana)

Pygeum is an herbal supplement derived from the bark of the Prunus africana tree.

Pygeum is often sold as a prostate health supplement, specifically to alleviate benign prostatic hyperplasia (BPH).

Further research is needed to determine if pygeum does exert this protective effect. Though one meta-analysis showed pygeum supplementation provides overall benefits for BPH, subsequent studies suffered from poor design and did not provide strong evidence.

Pygeum has been shown to reduce BPH proliferation invitro(in a test tube) by interfering with growth factors. It also has an anti­androgenic effect on its receptor. Additional studies are needed to determine if this effect takes place inside the human body after oral supplementation.

A meta-analysis3 assessing 18 trials with a sample of 1562 (although only being able to quantify a minimal amount; 5 with a sample of 430) was able to find a reduction in reported symptoms associated with benign prostatic hyperplasia associated with variable doses of pygeum bark extract in the range of 19-23%.

Erectile dysfunction (ED)

Erectile dysfunction (ED) is defined as the inability to achieve and/or maintain an appropriate penile erection that is sufficient for sexual intercourse and is clinically classified as psychogenic (such as relationship dissatisfaction, societal pressures, anxiety or depression) or organic (underlying causes or comorbidities). This is a common and increasing male sexual health concern, with a prevalence of up to 31% and projected to affect up to 322 million men by 2025. The prevalence of ED is reported as 1–10% of males aged <40 years (mostly psychogenic), >40% of men aged >40 years, and 50–100% of men aged >70 years (mostly organic).

Complementary and alternative medicines, including dietary supplements and herbal remedies, are increasingly being used for the treatment of ED, particularly through over-the-counter and internet

Dried fruit of Serenoa repens

sources4-7.

The increased use of alternative medicines and herbal remedies for ED with limited scientific investigations on extractions, efficacy, safety and dosage is a challenge to clinicians, whereas a comprehensive overview of clinically relevant research in these disciplines is currently lacking. Therefore, the present study aimed to systematically review and discuss the current evidence from placebo-controlled clinical trials that investigated the use of traditional medicine and herbal remedies in the management of ED as assessed by the IIEF (The International Index of Erectile Function).

The conclusion of the study was that the reported use of alternative medicines and herbal remedies for ED is extensive, particularly through dietary supplements available on the market. However, there is limited research into specific treatments for the improvement of erectile function. There is also a significant amount of heterogeneity in the interventions investigated and the dosage and duration. Based on the present results, Panax ginseng , and pycnogenol have some promising evidence as herbal products, alongside L-arginine as a nutritional supplement. The mechanisms of action remain unclear, but each of these appears to increase NO synthesis and NO production to induce erection. Importantly, improved diet and exercise should be considered, particularly in patients with obesity or diabetes mellitus8

L-carnitine

L-carnitine is a compound that is synthesized in the body from the amino acids lysine and methionine. It is also found in food, particularly in meat products. Acetyl-L-carnitine (ALCAR) is an acetylated form of L-carnitine that can cross the bloodbrain barrier more efficiently. L­carnitine is known for its role in the mitochondrial oxidation of longchain fatty acids.

L-carnitine has been shown to be useful in the treatment of liver diseases. It can reduce ammonia levels and improve symptoms of hepatic encephalopathy, as well as improve various markers of liver function. High doses of L-carnitine supplementation have also been found to improve sperm quality, and a small number of studies have reported improvements in male fertility.

Several studies have found an improvement in the case of erectile dysfunction, but more research is

needed to confirm its effects9,10,11 .

L-arginine

Arginine, also called L-arginine, is an amino acid used by the body as a protein building block. It’s also an intermediate metabolite in the urea cycle and the nitric oxide cycle.

In men with erectile dysfunction, daily supplementation with arginine can alleviate symptoms12 Many supplements promoted for ED and sexual enhancement have been found to be tainted with drug ingredients or related substances. Some products include combinations of multiple ingredients or excessively high doses, both of which can be dangerous. It is important to exercise caution when considering the use of supplements for ED.

Low testosterone levels

Testosterone is a well-known androgen, or male sex hormone, that is produced by the testicles. It plays a crucial role in the development and maintenance of secondary male characteristics, such as increased body and facial hair, a deepened voice, and increased muscle mass. When testosterone levels are low, due to a problem within the hypothalamic-pituitary-testicular (HPT) axis, it can result in a condition known as hypogonadism.

Some common signs and symptoms of low testosterone include a decreased sex drive, erectile dysfunction, low sperm count, reduced muscle mass and strength, increased fat mass, low bone density, loss of body hair, enlargement of breast tissue (gynecomastia), sleep disturbances, reduced energy levels, depressed mood, and difficulty concentrating.

While many supplements are marketed as testosterone boosters, there is little evidence to suggest that they have any significant impact on testosterone levels. However, supplementing with certain nutrients such as vitamin D, zinc, and magnesium may slightly increase testosterone levels if dietary intake and serum levels are inadequate.

DHEA

DHEA is a precursor to testosterone. As assigned males get older, their levels of testosterone gradually decline by 10% per decade after age 30. Through the use of DHEA supplements, many individuals aim to counter the effects of declining testosterone levels. Some evidence shows that DHEA increases libido and helps treat erectile dysfunction in men. DHEA can lead to improved libido as it may increase your free testosterone levels.

There appears to be an increase in testosterone following DHEA supplementation, but the vast majority of literature is in menopausal women (where testosterone contributes to libido). There is limited evidence of DHEA increasing testosterone in all studies including youthful athletes, which are less studied.

Conclusion

In summary, while there is evidence to suggest that specific supplements can contribute positively to men's health, a cautious approach is essential. Prior to initiating any supplementation regimen, consultation with a qualified healthcare provider is

strongly advised. Individual health status, dietary habits, and potential interactions with medications need to be taken into account. Moreover, supplements should not be viewed as standalone solutions but rather as part of a holistic strategy that incorporates a balanced diet, regular exercise, stress management, and adequate sleep for optimizing men's health and well-being.

Although it's important to present more scientific evidence to support the positive results, supplementing with various ingredients can bring numerous benefits to men's health on multiple levels.

References:

1 Moyad MA. Nutraceuticals and Phytotherapy in Men's Health: Antioxidants, Pro-oxidants, and a Novel Opportunity for Lifestyle Changes. Urol Clin North Am. 2022;49(2):239-248. doi:10.1016/j. ucl.2021.12.006

2 Bertaccini A, Giampaoli M, Cividini R, et al. Observational database serenoa repens (DOSSER): overview, analysis and results. A multicentric SIUrO (Italian Society of Oncological Urology) project. Arch Ital Urol Androl. 2012;84(3):117-122.

3 Wilt T, Ishani A, Mac Donald R, Rutks I, Stark G. Pygeum africanum for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2002;1998(1):CD001044. doi:10.1002/14651858.CD001044

4 Cui T, Kovell RC, Brooks DC, et al. guide to ingredients found in top-selling nutraceuticals for men’s sexual health. J Sex Med. 2015;12(11):2105–2117.

5 Sin VJ, Anand GS, Koh HL. Botanical medicine and natural products used for erectile dysfunction. Sex Med Rev. 2020. Online ahead of print. DOI: 10.1016/j.sxmr.2020.10.005

6 Corazza O, Martinotti G, Santacroce R, et al. Sexual enhancement products for sale online: raising awareness of the psychoactive effects of yohimbine, Maca, horny goat weed, and ginkgo biloba. Biomed Res Int. 2014;2014:841798.

7 Srivatsav A, Balasubramanian A, Pathak UI, et al. Efficacy and safety of common ingredients in aphrodisiacs used for erectile dysfunction: a review. Sex Med Rev. 2020;8(3):431–442.

8 Leisegang K, Finelli R. Alternative medicine and herbal remedies in the treatment of erectile dysfunction: A systematic review. Arab J Urol. 2021;19(3):323-339. Published 2021 Jun 11. doi:10.1080/2090598X.2021.1926753

9 Cavallini G, Modenini F, Vitali G, Koverech A. Acetyl-L-carnitine plus propionyl­L­carnitine improve efficacy of sildenafil in treatment of erectile dysfunction after bilateral nerve-sparing radical retropubic prostatectomy. Urology. 2005;66(5):1080-1085. doi:10.1016/j.urology.2005.05.014

10 Cavallini G, Caracciolo S, Vitali G, Modenini F, Biagiotti G. Carnitine versus androgen administration in the treatment of sexual dysfunction, depressed mood, and fatigue associated with male aging. Urology. 2004;63(4):641-646. doi:10.1016/j.urology.2003.11.009

11 Gentile V, Vicini P, Prigiotti G, Koverech A, Di Silverio F. Preliminary observations on the use of propionyl-L-carnitine in combination with sildenafil in patients with erectile dysfunction and diabetes. Curr Med Res Opin. 2004;20(9):1377-1384. doi:10.1185/030079904X2394

12 Rhim HC, Kim MS, Park YJ, et al. The Potential Role of Arginine Supplements on Erectile Dysfunction: A Systemic Review and Meta-Analysis [published correction appears in J Sex Med. 2020 Mar;17(3):560]. J Sex Med. 2019;16(2):223-234. doi:10.1016/j.jsxm. 2018.12.002

B2B Events Calendar 2025/2026

This is an overview of the B2B live events during 2025 and 2026

04-05 June, Munich https://www.cosmetic-business.com/

09-11 June, Vancouver https://probiotaamericas.com/live/en/page/ homepage

22-23 October, La Farga Barcelona https://www.cosmetorium.es/en/

28-30 October, Frankfurt https://www.cphi.com/europe/en/home.html

09-20 November, Malmömässan https://www.nordicorganicexpo.com/en/

19-20 November, Milano https://www.in-vitality.it/

30 November - 02 December, Paris https://natexpo.com/

02-04 December, Paris https://www.figlobal.com/europe/en/home.html 2026.

22-24 February, Bologna https://www.sana.it/en/home/1229.html

26-29 March, Bologna https://www.cosmoprof.com/

04-16 April, Paris https://www.in-cosmetics.com/global/en-gb.html

14-16 April, Warsaw

https://nutrafood.pl/en/

Cosmetovigilance

Cosmetovigilance is a crucial system for monitoring the safety and adverse effects of cosmetic products, ensuring consumer protection even after products reach the market. Collecting and analysing reports of undesirable reactions enables timely responses and continuous improvement in product safety and quality.

Cosmetovigilance is a relatively new branch of the pharmaceutical profession that deals with monitoring the safety and effectiveness of cosmetic products. Although cosmetics are generally considered safe for use, as with all other industries, problems can occasionally arise after a product enters the market. Cosmetovigilance therefore, focuses on identifying, analysing, and reporting adverse effects that may occur from the use of cosmetic products. This process encompasses a wide range of activities, from identifying safety risks to implementing preventive measures, and it plays a crucial role in protecting consumers.

Understanding cosmetic products

Cosmetic products include a broad category of items used for cleansing, caring for, and enhancing the appearance of human skin, hair, and nails. This includes products such as shampoos, creams, perfumes, deodorants, nail polishes, cleansers, and many other categories. While these products are not subject to regulations as strict as those for medications, they must still meet certain safety standards. In the European Union, for example, cosmetic products must comply with Regulation (EC) No. 1223/2009, which pertains to the safety of cosmetic products.

However, as with any product that comes into direct contact with the skin and mucous membranes, there is a possibility of adverse reactions, including allergies, irritation, or other long­term effects. Therefore, although safety assessment is mandato-

ry before a product is placed on the market, real­world use may reveal adverse effects only after a large number of consumers begin using the product.

The role of cosmetovigilance

Cosmetovigilance represents a system for monitoring, identifying, and analyzing adverse effects related to cosmetic products. A key component of cosmetovigilance is the collection and analysis of reports on undesirable effects, which may include irritations, allergic reactions, eczema, and even more serious problems such as burns or skin damage.

The final stage in the life cycle of a cosmetic product is its impact on consumers—an area where cosmetovigilance plays a central role. The collection of safety and quality data through this system enables manufacturers and regulatory authorities to identify potential issues and respond swiftly, for example, by withdrawing products from the market or conducting further investigations. Additionally, through this process, cosmetic companies can improve their product formulations and reduce the risk of negative effects on consumers.

Reporting adverse effects

For cosmetovigilance to function properly, it is essential that consumers, as well as healthcare professionals and distributors, report adverse reactions. Many countries have specialized reporting systems that provide a simple and quick way to notify the appropriate authorities about problems with products.

For instance, in the EU, there is a reporting system integrated into the European Commission’s database, which records all reported incidents related to cosmetic products.

Consumers are often unaware that they can report such incidents, so education and raising awareness about cosmetovigilance are of vital importance. A quick response and effective problem reporting allow for appropriate action to be taken to mitigate potential risks and prevent more serious consequences.

Regulation and manufacturer responsibility

Regulatory institutions such as the European Medicines Agency (EMA), the FDA in the United States, and other competent organizations around the world play a key role in cosmetovigilance. Cosmetic product manufacturers are obligated to ensure that products placed on the market are safe for use, and regulatory bodies conduct regular inspections to ensure all products meet prescribed standards.

Manufacturers must also maintain an effective product safety monitoring system, which includes collecting consumer feedback, implementing risk assessment procedures, and ensuring the ability to withdraw products if necessary. This proactive approach is essential to avoid major problems that could endanger consumer health.

Conclusion

Cosmetovigilance is an indispensable element in the cosmetics industry, as it contributes to consumer safety and protection. Although cosmetic products generally do not cause serious problems, ongoing monitoring and evaluation allow potential risks to be identified in a timely manner and appropriate corrective measures to be taken. With the continuous development of new ingredients and technologies, cosmetovigilance will continue to grow in importance and should be a fundamental priority for all those involved in the production, distribution, and regulation of cosmetic products.

BASF's Personal Care Business Wins BSB Innovation Prizes and Supplier Award

At in-cosmetics Global 2025, German consulting agency BSB awards BASF's ingredients Oximony™ , Verdessence® Maize and Lamesoft® OP Plus, and Cosmetic ingredients platform SpecialChem honors BASF as Most Popular Supplier.

During in-cosmetics Global in Amsterdam, BASF's Personal Care business unit received three Innovation Prizes from the German consulting agency BSB. At the same time, the company was named the most popular supplier ranked by product searches on SpecialChem. The platform provides access to a free industry product database of cosmetic and personal care ingredients. “It’s an honor to be recognized for our commitment to developing and delivering cutting-edge, sustainable solutions that meet the evolving needs of our customers and consumers worldwide. This recognition fuels our passion to continue pushing the boundaries of what is possible in the personal care industry,” said Peter Weinert, Vice President, Business Management Personal Care Europe, Middle East, and Africa at BASF.

The BSB Award recognizes innovative solutions in the cosmetics sector for finished products, raw materials, applied concepts, and industrial processes in various categories. The three ingredients have been awarded second place in their respective categories. Oximony™, a new active ingredient to enhance skin longevity, won the prize in the category “Cosmetics/Raw Materials – Active Substances”. Able to support the skin’s own healthy levels of Taurine, an amino acid naturally found in the human body, Oximony enhances skin vitality, helping to restore its radiance, resilience, and firmness. The ingredient is an extract of sustainably sourced and FairWild­certified Lysimachiachristinae , also known as Jin Qian Cao, an ancient botanical revered in traditional Chinese medicine.

Lamesoft® OP Plus, awarded in the category “Cosmetics/Raw Materials – Functionals and Recipients,” is a wax­based, readily biodegradable opacifier dispersion that can be used as an alternative to synthetic, acrylate-based ingredients. It is characterized by its high­opacifying efficacy and offers additional care benefits in rinse­off applications while ensuring easy formulation and cold processing. Lamesoft OP Plus provides a creamy white and caring appearance to formulations with various surfactant systems, without any undesired pearlizing effects during production and after storage. Moreover, it is suitable for formulations with alternatives to sulfate surfactants.

BASF’s Verdessence® Maize won in the category of “Natural Products/Raw Materials – Functionals and Recipients”. The plant-based styling ingredient and readily biodegradable alternative to PVP and VP/VA polymers is BASF’s latest addition to the company’s portfolio of high-performing biopolymers. Being 100% derived from renewable feedstocks, the new ingredient is perfectly suited for natural and organic cosmetics. It is designed for various applications, especially crystal-clear pump sprays as well as mousses with a cloud-like foam texture.

Moldavian Dragonhead Extract: A Natural Strategy to Enhance Collagen and Combat Skin Ageing

Moldavian dragonhead extract (Dracocephalummoldavica L.) has been shown to enhance collagen gene expression, improve skin hydration by over 70%, and increase dermal thickness in a placebo-controlled clinical study, presenting a promising natural strategy to combat skin ageing.

In a placebo-controlled clinical trial, Moldavian dragonhead extract (Dracocephalum moldavica L.) remarkably boosts collagen gene expression, enhances skin hydration by more than 70%, and increases dermal thickness as a natural way to prevent skin ageing. A recent publication from OBM Geriatric published the potent effect of the Moldavian dragonhead (Dracocephalum moldavica L.) extracts in skins against ageing through collagen stimulation.

Background

Skin ageing is characterised by a gradual decrease in collagen content, moisture, and dermal thickness, a process that is accelerated by oxidative stress, hormonal changes, and environmental exposure. Collagen, a structural protein that is vital for maintaining skin firmness and elasticity, is broken down as people age, which causes problems such as wrinkles and thinning of the skin.

In recent years, there has been growing interest in plant-based alternatives to collagen supplements. Moldavian dragonhead is a type of herb that contains flavonoid­glucuronides, particularly luteolinand apigenin-glucuronide, which have strong anti-

oxidant and anti­inflammatory properties that may help improve skin.

Experimental findings

In vitro experiments involving human dermal fibroblasts demonstrated that Moldavian dragonhead extract (MDH Nu sd) treatment resulted in a substantial elevation of key genes for extracellular matrix stability, including COL16A1, COL3A1, COL6A1, and biglycan (BGN). They are important in collagen fibril structure, skin elasticity, and skin resistance.

Clinical evidence

A randomized double-blind placebo-controlled clinical trial consisting of 103 healthy, female subjects aged between 35-65 years estimated the clinical effectiveness of daily oral supplementation (100 mg Moldavian dragonhead extract) over 12 weeks. Primary outcomes were:

• Skin hydration: statistically improved by 71.1% from baseline at week 12;

• Dermis thickness: increased by 8.7%, attributed to enhanced collagen deposition;

• Safety: the medication was well tolerated with no ill effects.

Mechanistic insights

Its effectiveness appears to be linked with its induction of collagen gene expression and putative modulation of the AMPK-FOXO1 pathway - a known tissue homeostasis and longevity regulator. These molecular mechanisms underlie the enhancements in dermal structure and hydration seen.

Conclusion

Moldavian dragonhead extract demonstrates great promise as a natural, safe, and effective substance for facilitating skin health and preventing aging-related dermal decline. Its performance as a natural cosmeceutical collagen-stimulating agent aligns with the growing desire for natural cosmeceutical therapies and is worthy of further research.

Reference:

Baumann J, Bönzli E, Wandrey F, Grothe T. Moldavian Dragonhead Extract: A Natural Collagen-Booster to Target Skin Aging. OBM Geriatrics 2025; 9(2): 305; doi:10.21926/obm.geriatr.2502305 .

Gut-Brain Axis Insights: Synbiotics Ease GI and Anxiety Symptoms in Autism

Initial evidence suggests a role for synbiotic supplements in managing digestive discomfort and enhancing behavioral wellbeing in autistic children.

Evidence from a clinical study deepens insight into role of the gut-brain axis, marking progress towards a more holistic strategy for managing gastrointestinal (GI), irritability and anxietyrelated symptoms in autistic children with synbiotics, either alone or in combination with gut-directed hypnotherapy (GDH).

A new study from the University of Queensland, published in the Journal of Autism and Developmental Disorders, has revealed that a combined intervention of a synbiotic and gut-directed hypnotherapy (GDH) significantly reduces gastrointestinal (GI) discomfort, irritability and anxiety symptoms in autistic children.1 The research provides new insight into the microbiome-gut-brain (MGB) axis and its role in autism, and creates an opportunity for supplement manufacturers to tap into demand for reliable, safe and effective solutions for increasing the standard of care for autistic children with comorbid gut symptoms.

Alterations in microbiota composition have long been associated with both autism spectrum disorder (ASD) and disorders of gut-brain interaction (DGBI), which are more common in children with autism, and are typically associated with stereotypical behavior, such as hyperactivity and anxiety.

Measuring success: study method, objectives and key results

The randomized pilot study involved 40 children diagnosed with ASD aged five to ten years. It compared the effects of synbiotics alone (SYN group) and synbiotics combined with GDH (COM group). Probiotics and prebiotics have both shown efficacy in improving GI and behavioral symptoms in autistic children, along with GDH, which is a commonly used treatment that aims to manage anxiety symptoms and normalize signals between the gut and the brain using relaxation techniques, guided imagery, and suggestive storytelling.

As a primary end point, the study set out to assess changes in GI scores evaluating common symptoms such as constipation or diarrhea, over a 12-week intervention period with a follow-up at 24 weeks. Interestingly, both groups exhibited significant reductions in GI symptoms post-intervention and at follow-up, with no superiority of the COM treatment over the SYN treatment.

A secondary objective was set to observe improvements in behavioral and anxiety symptoms. The

SYN group showed significantly improved scores for hyperactivity and stereotypical behavior. The COM group also showed improvements in these areas, in addition to irritability, social withdrawal, anxiety and inappropriate speech when compared to baseline.

The COM group also maintained significant reductions in GI pain scores at follow-up, suggesting lasting benefits of GDH when combined with synbiotic supplementation.

Changes in gut microbiome composition were also assessed as an exploratory benefit. These were observed across both groups, and included increases in Bifidobacterium animalis and Dialister , indicating a potential link between microbiome modulation and symptom improvement.

Together, these data suggest that synbiotics with or without GDH can help to support standard care for autistic children who also suffer from gut symptoms.

The opportunity

“The study contributes to a growing body of evidence suggesting that modulating the gut microbiome can have far­reaching effects beyond digestion, potentially influencing GI comfort, anxiety and behavior in autistic children,” said PD Dr. Robert E. Steinert, Principal Scientist at dsm­firmenich. “It represents a promising step towards a more holistic approach for managing symptoms in autistic children, and more widely, underscores the wider importance of the gut-brain axis in overall well-being. There is a clear opportunity here for supplement brands to expand their offerings with safe and targeted solutions that support higher standards of care for autistic children with comorbid gut symptoms.”

Powerful ingredients: Humiome® biotics

The study used biotics supplied by dsm­firmenich from its Humiome® portfolio, with the products chosen for their proven capability to improve gut health and supporting the gut-brain axis. The biotics supplied included a blend of Humiome® L. rhamnosus GG (ATCC 53103), Humiome® L.plantarum DSM 34532 (formerly known as L.plantarum TIFN101), Humiome® B. lactis DSM 32269 and B.longum DSM 32946.

More info: https://www.dsm­firmenich.com/en/ businesses/health-nutrition-care/segments/ dietary-supplements/health-from-the-gut.html

Vitafoods Europe Agenda: Experts Address Market Challenges and Opportunities in Barcelona

This year’s edition boasts a new theatre and three days of content focused around key industry growth areas, from women’s health to finished products and more.

Vitafoods Europe – the leading global platform for the nutraceutical, functional food and beverage, and dietary supplement industries

– has unveiled the line-up of speakers for its debut event at Fira Barcelona, Gran Via (20-22 May). This includes brand-new networking and content features – such as the Nutraceuticals Showcase Theatre, a Women’s Health Spotlight, a networking brunch and the Future of Nutrition Lunch & Learn – with sessions focused on helping brands close innovation gaps and find untapped market opportunities. The 2025 edition will be Vitafoods Europe’s biggest yet, with more content than ever before, cementing its status as the go-to event for innovation and insight.

A new theatre & fresh perspectives

Joining the show for 2025 is the Nutraceuticals Showcase Theatre (20–22 May), offering opportunities to hear from directly from the industry and gain insight into breakthrough innovations across the entire supply chain. With a growing focus on finished products to meet visitor demand, key sessions at this theatre include:

• Camille Binachon, Marketing Group Manager at Lallemand Health Solutions, on clinical innovations in healthy ageing

Jessica Spears, PhD, Assistant VP, Technical Operations at BIO-CAT Microbials, LLC, on taking probiotics from discovery to market.

Also joining the line-up is the new Women’s Health Spotlight (22 May at the Vitafoods Europe Conference Theatre). This feature will explore underrepresented areas in women’s health, from hormonal health to fertility, maternal wellness and more. Experts will discuss tackling the gap in the women’s health market to meet this demographic’s largely unmet needs, including:

Dr Hanine Estephan, Global Group Science and Wellness Director Holland & Barrett, on how personalised, science-backed wellness strategies can support women across every life stage

• Dr Zeina Alkhalaf, Head of Clinical Research at Mela Vitamins, on protecting women’s hormonal health Jennifer Cooper, President at Enova, on go-tomarket strategies for supporting women’s health at a deeper level.

Also new this year, the Future of Nutrition Lunch & Learn (21 May) will help delegates gain a competitive edge and fuel growth with actionable advice into hacking the mass market. This premium session will

offer future­facing perspectives from trailblazing brands, including a powerhouse panel discussion with experts from Kerry Health & Nutrition Institute, Mintel, Thimus and Retail VooDoo breaking down the strategies behind the industry’s biggest category disruptions. Plus, a masterclass from Teddie Levenfiche – the founder of leading matcha brand PerfectTed, one of the UK’s most exciting start-ups – will share insights into building a category­defining brand, scaling fast and standing out in a crowded market.

Fan favourites return

Alongside new content, the Vitafoods Insights Theatre (20-22 May) returns, inviting visitors to hear industry pioneers share insights for success in a range of fields – from marketing, procurement and branding to sustainability, regulatory and beyond. Discover blueprints for creating breakthrough brands with insights from the likes of Innova Market Insights, Healthy Marketing Team (HMT), Euromonitor International and the European Specialist Sports Nutrition Alliance (ESSNA). This show­floor staple promises three-days of expertly curated, on-trend sessions that are not to be missed.

Meanwhile, the Vitafoods Europe Conference (2021 May) is back by popular demand. For visitors looking stay ahead of the curve in an ever-changing industry, this packed two-day programme will feature expert-led presentations, panel discussions and case studies from the likes of Kline + Company, Mintel and more. Sessions will uncover the latest science, innovations, and strategies revolutionising the nutraceutical landscape in four key areas: Sports Nutrition and Active Lifestyle; Healthy Gut, Healthy Life; Cognitive and Emotional Health; and Lifelong Health.

“Everyone’s nutritional needs are unique, and this diversity opens the door to endless opportunities for innovation,” says Gareth Baguley Brand Director at Informa Markets. “The key to unlocking these opportunities is collaboration. Knowledge is most powerful when it is shared – Vitafoods Europe 2025 will bring together the industry’s brightest minds to inspire and share insights that will drive the industry forward and help us better support consumer wellness. This year’s agenda has been specially curated with an array of strategic, insight-driven sessions to help overcome innovation barriers and seize opportunities in this fast-growing market. We can't wait to welcome experts to the stage as we shape the future of nutrition together.”

More information: https://www.vitafoods.eu.com/en/home.html

Experience Vitafoods Europe in Barcelona

Your

Vitafoods.eu.com

The Best in Nutraceuticals Unveiled: Finalists Announced for Vitafoods Europe Innovation Awards 2025

Informa Markets has announced the finalists for the inaugural Vitafoods Europe Innovation Awards. Recognising excellence across ingredients, finished products, partnerships, and initiatives in the nutraceutical sector, the awards – supported by Vitafoods Europe Innovation Awards Sponsor Eladiet – celebrate the groundbreaking work shaping the future of nutrition and health.

From ingredient innovations to consumer-ready products, hundreds of forward-looking companies entered across seven diverse awards categories – with the judging process extended to accommodate the high volume of submissions. The result of this process has been a shortlist of 23 entries, representing the very best of the growing nutraceutical sector. Many of the innovations selected for the final stage leveraged natural ingredients in their innovation approach, and judges also observed a common theme of supporting holistic health –trends that reflect both the demand for clean label products and growing consumer awareness of the

role of nutrition in overall wellbeing. Speaking on the list of finalists, Prof. Colin Dennis, Chair Board of Trustees at International Food Information Service and Chair of the Vitafoods Europe Innovation Awards 2025, said: “We have been delighted by the diversity of entries to this year’s Vitafoods Europe Innovation Awards, showcasing the creativity and innovative developments shaping our sector. The high number of entries made our job of shortlisting difficult, but the result is a list of incredible innovation highlights which are advancing not only our industry, but the health of consumers and our planet. We’d like to thank all who entered, and we are

looking forward to hearing more from the finalists in-person at the show and celebrating together at the awards ceremony.”

Finalists of the awards will have an exclusive opportunity to pitch their innovations live to the esteemed panel of judges. Chaired by Prof. Colin Dennis, the panel will hear pitches on Monday, 19 May, the day before Vitafoods Europe opens its doors. Winners will then be announced at a highly anticipated awards ceremony taking place at Fira Barcelona, Gran Via after the conclusion of day 1 of the show, on Tuesday, 20 May, which promises to be an evening of celebration and inspiration, as well as an opportunity for exhibitors and invited guests to network and discover cutting-edge innovations.

The Vitafoods Europe Innovation Awards are supported by Sponsor Eladiet, as well as Official Digital Marketing Services Sponsor Smartcore.

Finalists:

Sports nutrition and active lifestyle ingredient

RhodioZen© – Pharmanager Ingredients

• Lactiplantibacillus plantarum TWK10® – Synbio Tech Inc.

• Okravive™ – Arjuna Natural Pvt. Ltd

Immune and gut health ingredient

Benicaros® – NutriLeads B.V.

• Heat-treated ES1 postbiotic – ADM

• 360GUT – Finzelberg GmbH & Co. KG

Cognitive and emotional health ingredient

B. breve MCC1274 – Morinaga Milk Industry Co., Ltd.

• RelaxPLX® – Monteloeder by Suannutra

• Vanizem® – Nektium Pharma

• Lactobacillus gasseri CP2305 – ADM

Healthy ageing ingredient

• N-utra – Nutriearth

• MindRevive® – Monteloeder by Suannutra

• Lifenol™ – Givaudan

Most innovative consumer-ready nutraceutical finished product

• Crispact® Capsules – PharmExtracta S.p.A.

• Probiotic Baby Oil – Ourvita

• Retico® – AronPharma

Most innovative industry partnership (open to non-exhibitors)

• OmeGo®-OptiGel® DR – Hofseth BioCare ASA

• icesupp – Icesupp Ltd.

• FZZR™ Technology – TSI Group x Bulk

Sustainability

Zooca® Calanus Oil – Zooca - The Calanus Company

• GUARABEST - Guarana Agronomy Project –Givaudan Nederland BV

• inavea™ – Nexira

TULSINITY® Bio – Laboratoires Expanscience

More information:

https://www.vitafoods.eu.com/en/whats-on/awards/ this-year.html

New Research Results in Lallemand

Lallemand Health Solutions is set to unveil groundbreaking scientific results from clinical research in innovative fields such as the gut-brainskin axis, gut-muscle axis, and cardiovascular health.

New breakthrough studies in healthy aging

Camille Binachon, Marketing Group Manager responsible for the healthy aging portfolio at Lallemand Health Solutions, teases: “We are launching Cerenity™, a powerful blend of three flagship probiotic strains designed to modulate the gut-muscle axis for healthy aging from within. In a new clinical trial, Cerenity™, combined with a prebiotic, supports mobility, strength, and quality of life in healthy aging. She adds, “Furthermore, we have new solutions revolving around cardiovascular health, expanding our healthy aging portfolio.”

New holistic beauty publication with Cerebiome® for the gut-brain-skin axis

Élodie Aragon, Product Manager in charge of the skin health portfolio, complements: “We have obtained very interesting results from a proof-of-concept study where healthy volunteers taking our pioneering psychobiotic Cerebiome® exhibited first significant results on in­and­out wellbeing. Participants noted improvement on perceived stress, circadian rhythm and skin appearance. Furthermore, this ingredient has been chosen as one of the three finalists for Ingredient of the Year in the Beauty from Within category, for the 2025 NutraIngredients Awards.”

Evidence demonstrating benefits on overall wellbeing, including

sleep

Karine Lasfargue, Product Manager for the mental health portfolio at Lallemand Health Solutions, emphasizes: “We collaborated with Dr. Morin, a renowned sleep specialist and Director of the Sleep Research Center at Université Laval in Quebec, Canada, to study the potential role of psychobiotics in sleep quality. Our research demonstrates how Cerebiome® can be beneficial in innovative fields beyond occasional stress.

“Scientific research is a major key driver for product development at Lallemand Health Solutions. Year after year, we are proud to document the health benefits of probiotics to bring tangible solutions to consumers,” concludes Isabelle Champié, Vice President of Sales and Marketing.

Aker BioMarine to Showcase Innovation and Science at Vitafoods 2025

Aker BioMarine Human Ingredients (Booth 3M127) is set to make a significant impact at Vitafoods 2025. As a leading innovator in human health and nutrition, Aker BioMarine specializes in sustainable marine-based health ingredients, and this year, the company is excited to showcase its premium portfolio beyond krill oil.

AUTHOR: Lisa Miller, Communications Director,

US

A spotlight on Revervia, and PL+

While Superba Krill remains a cornerstone of the company’s offerings, Aker BioMarine is excited to showcase Revervia, a newly launched algae ingredient that provides high-strength DHA from a sustainable, plant-based source. This expansion into algaebased solutions aligns with growing consumer demand for plant-based, clean-label supplements. PL+, a cutting-edge delivery platform designed to optimize the absorption of complementary ingredients with low bioavailability, ensuring maximum efficacy, will also be on display.

Innovation, science, and market trends

During the exhibition, Aker BioMarine’s team will share their expertise in product innovation, research, and health benefits. With a continued focus on sustainability and efficacy, they will highlight the ways in which their ingredients are enabling brands to develop unique, science-backed products tailored to today’s health-conscious consumers.

New Product Zone alert: Eterna - a premium formulation for healthy aging

Aker BioMarine will also introduce an advanced formulation, called Eterna, in the New Product Zone, combining three award-winning ingredients for healthy aging: Superba Krill, Kaneka Ubiquinol™, and AstaReal®

Produced with Swiss precision at Gelpell, this innovative formulation ensures high-quality manufac-

turing and stability, meeting the growing consumer demand for natural, organic, and sustainable dietary supplements.

Addressing the growing demand for women’s health solutions

Women’s health is emerging as a major focus area in the supplement industry. No longer a niche category, it has evolved into a booming market driven by informed, empowered consumers.

Aker BioMarine’s Superba Krill stands out as a key ingredient in women’s health regimens, offering targeted benefits that address PMS symptoms, and menopause-related symptoms and much more. Additionally, its unique blend of omega-3s, phospholipids, and choline supports skin health, cognitive function, heart health, and overall well-being - factors essential for healthy aging.

Visit

Aker BioMarine at booth 3M127

As the European dietary supplement market continues its rapid growth, brands are looking for sustainable, science-backed solutions. Aker BioMarine is at the forefront of this movement, offering highquality marine and plant-based ingredients that cater to the evolving needs of health-conscious consumers. Join Aker BioMarine at booth 3M127 at Vitafoods 2025 to explore their latest innovations, gain valuable insights, and discover how their premium ingredients can elevate your next product launch.

Verisol: Confirmed To Elevate Skin Hydration and Elasticity, While Reducing Wrinkles

Verisol, the patented and renowned collagen peptide for beauty-from-within, has once again demonstrated its positive impact on skin health.

Arecent randomized, double-blind, placebocontrolled clinical trial reaffirms its known benefits of reducing wrinkles and boosting skin elasticity but also unveils a new achievementimproved skin hydration.

This latest study, conducted over eight weeks, reveals that Verisol® delivers a significant increase in skin hydration in just four weeks. The positive clinical effects on wrinkle volume reduction and increased skin elasticity and hydration were even more pronounced after eight weeks, showcasing the comprehensive and transformative nature of Verisol•.

Further strengthening its position as a beauty industry game-changer, experiments with human skin cells demonstrated that Verisol supplementation leads to a statistically significant increase in the skin's extracellular matrix biosynthesis. This includes essential elements such as collagen, elastin, hyaluronic acid and proteoglycans. The observed stimulatory effect on the skin's extracellular matrix provides a plausible explanation for the consistently positive clinical outcomes.

It is noteworthy that these compelling clinical and in vitro results were achieved with Verisol derived from bovine sources. Importantly, this study affirms that the efficacy of Verisol® from bovine sources is parallel with previously studied Verisol sourced from porcine origins.

Lara Niemann, Gelita's beauty category manager, emphasizes the significance of these findings, stating, "Skin hydration is a prevailing consumer need, and Verisol® now offers clinical substantiation on this parameter in addition to reduced wrinkles and increased elasticity. With a low 2.5 g daily dose, Verisol provides economical cost in use and it also boasts confirmation by now seven published Verisol ­specific studies. Verisol continues to change the face of beauty by setting the benchmark in scientific substantiation, clinical efficacy, and industry and consumer acceptance and confidence, propelling the beauty-from-within market forward."

Of note, this study assures that markets with specific religious practices or ethnic norms and that prefer bovine­sourced Verisol have clinical confirmation that Verisol delivers multiple benefits to the skin, independent of the raw material type.

It is crucial to note that the results of this study

are exclusive to patented Verisol and cannot be readily applied to other collagen peptides, solidifying Verisol 's unique standing in the beauty and skin supplement landscape.

Full study: The Oral Intake of Specific Bovine­Derived Bioactive Collagen Peptides Has a Stimulatory Effect on Dermal Matrix Synthesis and Improves Various Clinical Skin Parameters

www.GELITA.com

medicinal plants photo herbarium

Magnolia (Magnoliaofficinalis)

Magnolia officinalis is a pharmacologically significant species within the Magnoliaceae family, traditionally utilized in Chinese medicine for its wide range of therapeutic effects. Its bioactive constituents, particularly honokiol and magnolol, have attracted increasing scientific interest due to their demonstrated anxiolytic, anti-inflammatory, and neuroprotective properties.

TAXONOMY

kingdom: Plantae

order: Magnoliales

family: Magnoliaceae

genus: Magnolia

species: Magnolia officinalis

COMMON NAME

Magnolia bark, Hou Po (Chinese), Chinese magnolia, Magnoliae cortex

FLOWERING TIME

V–VI month

Botanical description

Magnolia officinalis is a deciduous tree native to China, belonging to the Magnoliaceae family. It typically grows between 20–25 meters tall and is characterised by large, broad leaves and fragrant white to creamy flowers that bloom in late spring. The bark of the tree is thick, smooth, and gray-brown, and it is highly valued for its medicinal properties.

The plant's bark is harvested in the summer and dried for use in traditional and modern herbal medicine. Magnolia trees are widely appreciated for their ornamental beauty and powerful botanical compounds.

Habitat & cultivation

Magnolia officinalis thrives in warm, humid climates and is commonly found in forested mountain regions of central and southern China. It prefers welldrained, fertile soils and grows best in areas with full sun to partial shade.

The tree is cultivated for both medicinal use and ornamental purposes. Sustainable harvesting practices are recommended, as overharvesting of wild magnolia populations has led to conservation concerns in some regions.

Magnolia spp.

Use for medicinal

purposes

Magnoliaofficinalis bark has been used for centuries in Traditional Chinese Medicine (TCM) to promote digestive health, reduce stress, and support respiratory function. In modern herbal medicine, it is gaining recognition for its calming and adaptogenic properties, particularly its impact on mood, sleep, and metabolic regulation.

Traditional medicinal uses

Magnolia bark has been traditionally used for to treat include asthma, anxiety, depression, stomach disorders, and inflammation.

Constituents

• Honokiol

• Magnolol

Lignans

• Essential oils

• Alkaloids

Action and application

The key bioactive compounds, honokiol and magnolol, exhibit strong anxiolytic, anti­inflammatory, antioxidant, and neuroprotective effects. They were first noted in plants of the Magnolia family, in teas (known as saiboku-to) used historically to treat asthma and anxiety.

Magnolia officinalis is commonly used in stressrelief formulations and supplements designed to support sleep, mood regulation, and metabolic balance. Its adaptogenic qualities make it a valuable addition to nootropic, weight management, and hormone-balancing products.

Caution

Despite a well-documented use of Magnolia in TCM and a wealth of in vitro and in vivo pharmacological studies, there are practically no clinical studies published in English. It is now necessary to establish suitable modern standards, techniques, and methods to evaluate the safety of such herbal products alone and in association.

References:

Fujita, M., Itokawa, H., & Sashida, Y. (1973). Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan, 93(4), 429–434. https://doi.org/10.1248/yakushi1947.93.4_429

Pandey, P.; Kumarihamy, M.; Chaturvedi, K.; Ibrahim, M.A.M.; Lambert, J.A.; Godfrey, M.; Doerksen, R.J.; Muhammad, I. In Vitro and In Silico Studies of Neolignans from Magnolia grandiflora L. Seeds against Human Cannabinoids and Opioid Receptors. Molecules 2023, 28, 1253. https://doi.org/10.3390/molecules28031253

Poivre, M., & Duez, P. (2017). Biological activity and toxicity of the Chinese herb Magnolia officinalis Rehder & E. Wilson (Houpo) and its constituents. Journal of Zhejiang University. Science. B, 18(3), 194–214. https://doi.org/10.1631/jzus.B1600299

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