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Clinical Study July 2009

MKG/BSL-0908 p1

CONFIDENTIAL


Clinical Study Evaluation of Cacti-Nea™’s diuretic effect in women showing water retention. Design of the clinical study : Monocentric, randomized, placebo-controlled, in parallel double-blind format 49 women divided into 2 groups Normal BMI, between 20 and 25 Aged between 20 and 60 28-days treatment Tested dosage of Cacti-Nea™ = 2g/day MKG/BSL-0908 p2

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Clinical Study

Parameters analysed during the study: Body water mass

Urinary parameters (sodium, potassium, uric acid)*

Body weight

Blood pressure

Body fat mass

Circumference: waist, hip, thigh, calf, ankle

Body lean mass *Urinary volumes/24H could not be measured within the framework of this study

MKG/BSL-0908 p3

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Clinical Study Process of the study Pre-inclusion

Inclusion

D-14

D0

Clinical exam

Clinical exam

2 weeks

D7

D14

D21

Clinical exam

Cacti-Nea™ 2g/d

1 week

1 week

Blood sampling

1 week

Placebo 2g/d

On the day of the visits : Collection of the 24h urines

Weighing, Bio-impedance analysis(Bodystat 1500MDD), anthropometric measures

MKG/BSL-0908 p4

D28

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1 week

Blood sampling


Clinical Study

Results presentation • per protocole population (47 women)* Placebo group: 24 women Cacti-Nea™ group: 23 women

• sub-group/FM, women who tend to gain body fat between D-14 & D0 (27 women) Placebo group: 12 women Cacti-Nea™ group: 15 women

* 2 volunteers did not respect the protocole and were withdrawn from the total population. MKG/BSL-0908 p5

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Results – per protocole population

Characteristics of the per protocole population at Day0 Average age

Average BMI at D0

Waist circumference at D0

Average weight at D0

Placebo

39.6

22.9

76.8 cm

60.4 kg

Cacti-Nea™

40.1

23.2

76.5 cm

61.3 kg

Body fat mass at D0

Body lean mass at D0

Body water mass at D0

Placebo

18.3 kg

42.1 kg

31.1 kg

Cacti-Nea™

18.9 kg

42.3 kg

31.2 kg

MKG/BSL-0908 p6

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Results – Sub-group/FM

Characteristics of the sub-group/FM at Day0 Average age

Average BMI at D0

Waist circumference at D0

Average weight at D0

Placebo

40.5

23.2

76.5 cm

59.8 kg

Cacti-Nea™

38.8

22.8

75.8 cm

61.2 kg

Placebo Cacti-Nea™

MKG/BSL-0908 p7

Body fat mass at D0

Body lean mass at D0

Body water mass at D0

18.8 kg

41 kg

30.6 kg

19 kg

42,2 kg

30.8 kg

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Results – Body Composition Per protocole Population No gain of body Fat Mass in the Cacti-Nea™ group Body fat mass variation between D0 & D28 1000

Up to +3kg of body fat mass in the Placebo group

Variation (g)

800 600 400 200 0 -200 -400

MKG/BSL-0908 p8

Placebo

Cacti-Nea

p= 0.0239

NS

CONFIDENTIAL


Results – Body Composition Sub-group/FM Sub-group Fat mass variation between D0 & D28 Placebo

Sub-group Fat mass variation between D7 & D28 Placebo

Cacti-Nea

1200

1200

900 Variation (g)

900 Variation (g)

Cacti-Nea

600 300 0

600 300 0

-300

-300

-600

-600

-900

-900

p= 0.0653

NS

p= 0.0273

Body fat mass D0 & D28 Significant trend in the Placebo group

MKG/BSL-0908 p9

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NS

Body Fat mass D7 & D28 Significant increase in the Placebo group


Results – Body Composition Per protocole population vs. Sub-group/FM Cacti-Nea™ seems to have a positive effect on the body composition balance. In the per protocole population , we observe a significant increase of the body fat mass in the Placebo group (+3.4%) whereas it does not vary in the CactiNea™ group. (Graph: Fat mass variation between D0 & D28).

This significant increase of the body fat mass in the Placebo group is confirmed in the sub-group/FM: +3.2% (Graphs : Sub-group fat mass variation between D0 & D28 and between D7 & D28)

The lean mass consistently follows the water mass evolution in both groups

MKG/BSL-0908 p 10

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Results – Body Composition

The gain of fat mass observed in women of the placebo group could be linked with two phenomenon: A reverse placebo effect : People selected for weight-management clinical studies could feel less guilty and allow themselves food misbehaviors. An effect “restriction/storage”: A strict restriction in sugar and fat could, as a paradox, favor the body fat storage in case of food misbehaviors. These misbehaviors and their consequences seem to be corrected and avoided thanks to Cacti-Nea™ whereas it is not the case in the Placebo group. MKG/BSL-0908 p 11

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Results – Water mass Per protocole population vs. Sub-group/FM Per protocole population

Sub-group/FM

Water mass variation between D7 & D28 Cacti-Nea

Placebo

0

0

-150

-150

-300

Variation ( g)

Variation ( g)

Placebo

Sub-group water mass variation between D7 & D28

-450 -600

-300 -450 -600

-750

-750

-900

-900

p= 0.0151

p= 0.0107

Cacti-Nea

NS

p= 0.0094

In this sub-group, Cacti-Nea™ induces a significant water mass reduction MKG/BSL-0908 p 12

CONFIDENTIAL


Results – Water mass Per protocole population vs. Sub-group/FM After 4 weeks treatment, a water mass decrease was observed in both groups on the per protocole population. After the first week: - Per protocole population: the water mass reduction observed in the CactiNea™ group becomes more important than the one observed in the Placebo group. (Graph : Water mass variation between D7 & D28).

- Sub-group/FM : the water mass loss is significant in the Cacti-Nea™ group whereas it is not significant in the Placebo group. (Graph: Sub-group water mass variation between D7 & D28).

The activity of Cacti-Nea™ in the organism may imply a physiological adaptation so that its effect can only be seen after a few days of treatment (D7). MKG/BSL-0908 p 13

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Results – Body weight Per protocole population After 4 weeks treatment, we observe a significant body weight loss in the Cacti-Nea™ group (between D7 & D28; D14 & D28; D21 & D28 ) whereas no effect is observed in the Placebo group. Body weight variation between D7 & D28 200

Up to 3.3kg of weight loss in the Cacti-Nea™ group

Variation (g)

0 -200 -400 -600 -800 Placebo

NS

MKG/BSL-0908 p 14

Cacti-Nea

p= 0.0487

CONFIDENTIAL


Results – Body weight Sub-group/ FM After 4 weeks treatment, we observe a body weight loss in the Cacti-Nea™ group (about -600g), according to a significant trend between D0 & D28. This weight loss becomes significant between D7 & D28, whereas no significant effect is observed in the Placebo group. Sub-group body weight variation between D0 & D28 Placebo

Sub-group body weight variation between D7 & D28 Placebo

Cacti-Nea

600

Variation (g)

Variation (g)

600 200 -200 -600

200 -200 -600

-1000

-1000

NS MKG/BSL-0908 p 15

Cacti-Nea

p= 0.0726 CONFIDENTIAL

NS

p= 0.0334


Results – Water Mass / Body Weight

Placebo vs. Cacti-Nea™ As no weight loss was observed in the Placebo group, we can consider that the water mass loss is entirely compensated by a fat mass gain. On the contrary, the water mass loss observed in the Cacti-Nea™ group goes along with a significant body weight loss in both studied populations : - Per protocole population : -0.430 kg (p=0.0487 between D7 & D28). - Sub-group/FM : -0.667 kg (p=0.0334 between D7 & D28).

MKG/BSL-0908 p 16

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Results – Blood pressure Per protocole population Cacti-Nea™ does not show any side effect on blood pressure (systolic & diastolic) between D0 & D28, unlike other diuretic substances. Diastolic blood pressure variation between D0 & D28

Placebo

Cacti-Nea

1,5

mmHg

0 -1,5 -3 -4,5 -6

p= 0.0373

MKG/BSL-0908 p 17

NS

CONFIDENTIAL

No negative effect observed on blood pressure


Results – Blood pressure Sub-group/ FM In this sub-group, Cacti-Nea™ still does not show any side effect on blood pressure (systolic & diastolic) between D0 & D28, unlike other diuretic substances. Diastolic blood pressure variation between D0 & D28

150

100

120

80

90

60

mmHg

mmHg

Systolic blood pressure variation between D0 & D28

60 30

20

0

0

Placebo

NS

MKG/BSL-0908 p 18

40

Cacti-Nea

NS

Placebo

NS

CONFIDENTIAL

Cacti-Nea

NS


Results – Urinary parameters Per protocole population Urinary parameters and Mineral Balance: No significant difference observed between the Placebo group and the Cacti-Nea™ group concerning: • urinary rate of uric acid • urinary rate of sodium • urinary rate of potassium Cacti-Nea™ does not imply any side effect on the mineral balance : No excessive loss of mineral contrary to other diuretic substances.

MKG/BSL-0908 p 19

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Synthesis of the Results Per protocole population vs. Sub-group/FM Effects observed in the per protocole population are confirmed and even more notable in the sub-group/FM : the volunteers of the sub-group/FM seem to be more receptive to Cacti-Nea™. Water mass reduction between D7 and D28 : -0.647 kg in the Cacti-Nea™ sub-group/FM (Placebo: NS) ”Anti-Fat mass“ effect of Cacti-Nea™ against: +0.717 kg in the Placebo sub-group/FM Body weight loss between D7 and D28 : -0.667 kg in the Cacti-Nea™ sub-group/FM (Placebo: NS) In the Sub-group/FM, Cacti-Nea™’s effects are completed by an improvement of some anthropometrical parameters.

MKG/BSL-0908 p 20

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Results – Anthropometrical parameters Sub-group calf circumference variation between D7 & D28

Sub-group/FM

Placebo

Cacti-Nea

Sub-group ankle circumference variation between Placebo D0 & D28 Cacti-Nea 0,2

Variation (cm)

0,2 0,1 0 -0,1 -0,2

Variation (cm)

0,1 -0,3

0

NS

-0,1

p= 0.087

-0,2 -0,3

Sub-group waist circumference variation between PlaceboD14 & D28 Cacti-Nea

-0,4

p= 0.002

0,2

Up to 1.4 cm reduction of waist circumference in the Cacti-Nea™ group

Variation (cm)

NS

0,1 0

-0,1 -0,2 -0,3 -0,4

NS MKG/BSL-0908 p 21

CONFIDENTIAL

p= 0.0498


Results – Anthropometrical parameters Sub-group/FM In the sub-group/FM, anthropometrical parameters are significantly improved after 4 weeks of Cacti-Nea™ consumption. Between D0 and D28, the ankle circumference is significantly reduced in the Cacti-Nea™ group. (Graph : Sub-group ankle circumference variation between D0 & D28)

Between D7 and D28, the calf circumference is reduced according to a significant trend in the Cacti-Nea™ group. (Graph : Sub-group calf circumference variation between D7 & D28)

A significant reduction of waist circumference is observed in volunteers of the Cacti-Nea™ group between D14 & D28. (Graph : Sub-group waist circumference variation between D14 & D28)

MKG/BSL-0908 p 22

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Discussion and Conclusions

Some element to discuss, & First Conclusions

MKG/BSL-0908 p 23

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Discussion

The sub-group of women who tend to gain fat mass is particularly receptive to Cacti-Nea™. > A justified sub-group > Diuretic & Weight management : a potential solution against cellulite…

MKG/BSL-0908 p 24

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Discussion A justified sub-group This sub-group corresponds to women whose body fat mass increased before the beginning of the study (between D-14 pre-inclusion visit and D0 inclusion visit). = Fat mass increase, while they were not « treated » A lot of factors may influence the gain of fat mass (heredity, hormonal factors, food intake, lack of physical exercise…). This sub-group is absolutely legitimated : scientifically-speaking (evolution of fat mass observed before D0) and also strategically-speaking (27 volunteers out of 47 were concerned).

MKG/BSL-0908 p 25

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Discussion Diuretic and weight-management Cacti-Nea™ : A natural ingredient with DIURETIC and WEIGH-MANAGEMENT properties intimately linked.  With Cacti-Nea™, the diuretic effect is followed by an improvement of the body composition and a moderate but steady weight loss. D0

4 weeks Cacti-Nea™

D7

Body adaptation

D14

D21

Growing diuretic effect Anti-fat mass effect Significant weight loss between D7 & D28, D14 & D28 and between D21 & D28

MKG/BSL-0908 p 26

CONFIDENTIAL

D28


Discussion Excess water reduction & Weight management : a potential solution against cellulite… The water mass reduction, the fat mass gain limitation, and the moderate weight loss observed can be considered as good indicators of Cacti-Nea™’s diuretic and weight management properties. On a targeted sub-group, Cacti-Nea™ also shows a positive effect on the silhouette. Excess water reduction / weight management / silhouette These results suggest that Cacti-Nea™ could have a beneficial effect on some kind of cellulite (adipose, aqueous or mixed cellulite)… For example, the significant effect of Cacti-Nea™ observed on ankle circumference reduction is to be linked with aqueous cellulite.

MKG/BSL-0908 p 27

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Conclusions Very positive results on a normal population (BMI between 20 & 25): Progressive induction of body water mass loss (linked to the diuretic effect already highlighted in the in vivo rat study)

Limitation of fat mass gain Help for weight control / moderate weight loss No side effect on blood pressure Preserved mineral balance

A particularly receptive population confirms the WEIGHT MANAGEMENT & WELL-BEING potential of the ingredient Cacti-Nea™ MKG/BSL-0908 p 28

CONFIDENTIAL


Conclusions Sub-group/FM (N=27) Placebo Body composition/ Weight

Anthropometrical sizes

Fat mass

 (a)



Water mass



 (a)

Body weight



 (a)

Waist



 (a)

Calf



 (b)

Ankle



 (a)





Acide urique





K+





Na+





Blood pressure Urinary parameters

(a): p<0.05 ; (b): p<0.1 MKG/BSL-0908 p 29

Cacti-NeaTM

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Many thanks for your attention !

MKG/BSL-0908 p 30

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Studio sugli effetti dimagranti di Cacti-Nea