BioSerae_Diuretic & Weight Management Significant Clinical Results_2009_v2

8/8/2019 BioSerae_Diuretic & Weight Management Significant Clinical Results_2009_v2

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Diuretic & Weight management:

Significant Clinical results

Cacti-Nea™ is an original nutraceutical ingredientdeveloped by Bio Serae Laboratories from Opuntiaficus indica cactus fruit. A recent clinical studyconfirms Cacti-Nea™'s diuretic and weightmanagement properties.

This original cactus fruit ingredient will naturally helpto refine the silhouette & regain body's tone, whichmakes it the perfect ingredient for weightmanagement formulations.

Cacti-Nea™ is 100% soluble and can be incorporatedinto dietary supplements or any food and beverageproducts.

Don't miss the opportunity to learn more about it!

Table of contents :

Introduction....................................................................2

Original cactus fruit water extract....................................2

Preliminary results supporting Cacti-Nea™'s weightmanagement properties (on-going publication) ...................3

New clinical study on Cacti-Nea™'s diuretic properties ....4

General technical data .................................................... 8

Bibliography....................................................................9




Introduction

Cacti-Nea™ is a natural water extract of prickly pear cactus fruit (Opuntia ficus-indica) which already revealed

original diuretic and antioxidant properties (bibliographical data, in vivo study on rats). At the light of these

encouraging data, Bio Serae Laboratories recently conducted a clinical study in order to confirm the

diuretic and weight management effect of Cacti-Nea™ on Human, and to enrich its scientific background.

This technical paper will first introduce the prickly pear fruits and their exceptional nutritional content. We will

review the preliminary studies which support the diuretic properties of Cacti-Nea™ and will then explore the

results of the latest clinical study.

Original cactus fruit water extract

Prickly pear cactus (also called Opuntia ficus-indica) was introduced into the Mediterranean area as of the XVIth

century. This plant was indeed well adapted to the climatic conditions of arid and semi-arid regions and offered a

good alternative as fodder plant to local farmers.

For many years now, Bio Serae has established strong partnerships with Opuntia ficus-indica producers, and

conducted extensive research works aiming at improving their know-how on prickly pear cactus. At the light ofthe exceptional nutritional properties of prickly pear Bio Serae Laboratories developed an exclusive process

designed to preserve the nutritional properties of the fruit and now offer Cacti-Nea™, a soluble cactus fruit

powder naturally rich in indicaxanthin with diuretic and weight-management properties.




Preliminary results supporting Cacti-Nea™'s weightmanagement properties

(on-going publication)

Several scientific studies were conducted on prickly pear fruit ( in vitro, in vivo) and showed diuretic properties of

these cactus fruits (Perfumi & Tacconi, 1996; Galati et al ., 2002). Early in 2008, Bio Serae conducted a specific in

vivo study on rats which confirmed the significant diuretic effect of its original and branded cactus fruit ingredient,

Cacti-Nea™. The results of this study will soon be published in Phytotherapy Research.

The aim of this study was to evaluate the diuretic property of Cacti-Nea™, original cactus fruit extract, orally

administrated to male Wistar rats at the dose of 240 mg/kg/day.

After a 7-days acclimatization period to the laboratory conditions, 18 rats, weighted 150 to 175 g, were

randomised on their weight basis in 3 groups (n=6) :» a control group,

» a group treated with hydrochlorothiazide at a dose of 10 mg/kg/day

» a group treated with Cacti-Nea™ at a dose of 240 mg/kg/day (corresponding to an equivalent human

dosage of 2g/day).

Daily oral treatment of rats (D1 to D7)Group

Number ofrats Product administrated Dose (mg/kg)

Control 6 water -

Hydrochlorothiazide 6 Hydrochlorothiazide 10

Cacti-Nea™ 240 6 Cacti-Nea™ 240

The animals were weighted daily so they were administrated the proper dose of tested substance. The average

daily consumption of food was 15 to 20 g/rat and the average daily consumption of water was 20 to 25 g/rat.

The viability and behavior of the animals were recorded daily and the main parameters measured were the urine

volume / 24 hours and the urinary parameters (levels of sodium, potassium and uric acid).

The results showed that, along with a regular hydration,

Cacti-Nea™ helped to :

> Improve elimination of excess fluids : For the same amount of water ingested by rats, Cacti-Nea™ showed a significant diuretic effect by doublingthe urine volume (p=0.03).

> Control weight gain :This 7-days study conducted on rats showed thatconsumption of Cacti-Nea™ induced a reduction ofweight gain by almost 20% compared to control.

> Preserve minerals balanceNo adverse effect was observed on the minerals balance which confirm the safety of the ingredient.




New clinical study on Cacti-Nea™'s diuretic properties

Bio Serae conducted in 2009 a clinical study in order to evaluate Cacti-Nea™'s diuretic effect in women showing

water retention.

Design of the clinical study

The 28-days clinical study was conducted on 49 women with normal BMI (between 20 and 25), placebo

controlled, in parallel double blind format, monocentric and randomised, with a daily dose of Cacti-Nea™ of 2g.

The parameters analysed during the study were :

> Body water mass

> Body weight

> Body fat mass

> Body lean mass

> Urinary parameters (sodium, potassium, uric acid)

> Blood pressure

> Circumference: waist, hip, tight, scalf, ankle

The results have been analysed on the per protocole population and on a specific sub-group particularly sensitive

to Cacti-Nea™ effects.

> per protocole population (47 women) including 24 women in the Placebo group and 23 women in the

Cacti-Nea™ group.

> sub-group/FM (27 women) : This sub-group corresponds to women who tend to gain body fat between

D-14 (pre-inclusion visit) & D0 (inclusion visit, start of the study). This sub-group was divided in 12

women in the Placebo group and 15 women in the Cacti-Nea™ group.

Results

Positive effect on body composition

In the per protocole population, the body fat mass increases in the Placebo group (+3.4%) according a significant

trend, whereas it does not vary in the Cacti-Nea™ group.

This effect on the body fat mass in the Placebo group is confirmed and reinforced (p=0.0273) 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.

p=0.0653

V a r i a t i o n

i n

k g

Placebo Cacti-Nea™

NS

Sub-group Fat mass variation between D0 & D28

-0,9-0,6

-0,3

0

0,3

0,6

0,9

1,2

p=0.0273

V a r i a t i o n

i n

k g


NS-0,9-0,6

-0,3

0

0,3

0,6

0,9

1,2

Sub-group Fat mass variation between D7 & D28

Sub-group/FM




Reduction of Water mass

After 4 weeks of 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 Cacti-Nea™ 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).

Reduction of Body weight

We observe a significant weight loss in the Cacti-Nea™ group (up to 3.3 kg of weight loss) whereas nothing in the

placebo group.

As no weight loss was observed in the Placebo group, we can consider that the water mass loss is entirelycompensated by the 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).

Per protocole population Sub-group/FM

Water mass variation between D7 & D28

V

a r i a t i o n

( k g )

p= 0.0151 p= 0.0107-0,9

-0,75

-0,6

-0,45

-0,3

-0,15

0Cacti-Nea™Placebo

V a

r i a t i o n

( k g )

NS p= 0.0094-1

-0,8

-0,6

-0,4

-0,2

0Cacti-Nea™Placebo

Sub-group water mass variation between D7 & D28




Per protocole population

No adverse effect on Blood pressure

In both populations, Cacti-Nea™ does not show any side effect on blood pressure (systolic & diastolic) between

D0 & D28, unlike other diuretic substances.

No adverse effect was observed on blood pressure.

No adverse effect on minerals balance and urinary parameters

No significant difference observed between the Placebo group and the Cacti-Nea™ group concerning the urinary

rates of uric acid, sodium and potassium.

Cacti-Nea™ does not imply any side effect on the mineral balance : No excessive loss of mineral contrary to other

diuretic substances.

Discussion

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™ Vs. body fat gain in the Placebo sub-group/FM (+0.717 kg)

> 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 after 4 weeks of Cacti-Nea™ consumption :

> Between D0 and D28, the ankle circumference is significantly reduced in the Cacti-Nea™ group.

> Between D7 and D28, the calf circumference is reduced according to a significant trend in the Cacti-

Nea™ group.

> A significant reduction of waist circumference is observed in volunteers of the Cacti-Nea™ group

between D14 & D28.

Up to 3.3kg ofweight loss in

the Cacti-Nea™group

NS-0,8

-0,6

-0,4

-0,2

0

0,2

V a r i a t i o n

i n

k g


=0.0487

Bod wei ht variation between D7 & D28




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.

The positive results obtained on excess water reduction, weight management and the silhouette suggest that

Cacti-Nea™ could have a beneficial effect on some kind of cellulite (adipose, aqueous or mixed cellulite).

It is indeed known that women with normal BMI (between 20 and 25) and showing water retention are more

likely to develop aqueous cellulite, the preferred areas of such cellulite being tights, calves, ankles and arms. The

water mass reduction observed in Cacti-Nea™ groups of both populations being associated with an ankle

circumference reduction allows to think that Cacti-Nea™ could help against aqueous cellulite troubles.

Conclusion

Very positive results were highlighted, confirming the benefits of this innovative ingredient :

> Cacti-Nea™ induces a positive effect on body composition by limiting fat mass gain.

> Cacti-Nea™ shows a significant reduction of water mass after one week of treatment.

> We observe a significant weight loss in the Cacti-Nea™ group, while no effect on body weight was

observed in the placebo group.

> Contrary to other diuretic substances, Cacti-Nea™ does not show any side effect on blood pressure

nor on mineral balance.

This clinical study allows to identify a specific sub-group of women particularly sensitive to the benefits of Cacti-

Nea™. This target corresponds to women with a normal BMI who combine water retention troubles and a natural

trend to gain fat mass.

Cacti-Nea™ offers to this population an efficient and natural solution to limit fat mass gain, favor elimination of

excess fluids and refine the silhouette without any side effect.




General technical data

Recommended dosage

The daily recommended dosage is 2 g per day. This dosage was established on the basis of various studies carried

out on the fresh fruit, and was confirmed by the recent in vivo and clinical studies conducted by Bio Serae

Laboratories.

Food grade ingredient status

Cacti-Nea™ is a cactus fruit (Opuntia ficus indica) soluble powder. This kind of fruit has been traditionally

consumed for several centuries throughout the world and is well-known for its exceptional nutritional properties.

The raw material from which Cacti-Nea™ is made is considered as a traditional, every day consumption fruit:

Cacti-Nea™ can therefore be considered as a food grade ingredient and is exempted from the European Union

Novel Food Procedures.

Moreover, Bio Serae Laboratoires has asked for the necessary authorization to the French Authorities (DGCCRF)

regarding Cacti-Nea™, according to decree 2006-352. The notification report of Cacti-Nea™ as a food

supplement was sent to the French Authorities in April 2008. We attested that Cacti-Nea™ complies with the

French regulation since June 2008 according to the Article 16 of the Decree 2006-352.

Renewable & organic raw material

The fruits used for the production of Cacti-Nea™ come from organic plantations of Opuntia ficus-indica cactus.

Unlike intensive farming practices, the cactus production uses no fertilizer, nor phytosanitary treatment. The

production of the fruits is in conformity with organic farming and respectful of the environment. The harvesting is

entirely carried out with the hand preserving the natural resource.

Various applications

Cacti-Nea™ is a fine powder, with a beautiful pink-orange color. It can be

used in capsules as well as in the form of tablets.

Cacti-Nea™ Instant form is also available for a better cold solubility. Thisingredient can thus be part of an instant drink formula, or be added into

stick to be dissolved in a glass of water.




Bibliography

Butera D, Tesoriere L, Di Gaudio F, Bongiorno A, Allegra M, Pintaudi AM, Kohen R, Livrea MA. Antioxidant

activities of sicilian prickly pear (Opuntia ficus indica) fruit extracts and reducing properties of its betalains: betanin

and indicaxanthin. J Agric Food Chem. 2002;50(23):6895-601.

Galati EM, Tripodo MM, Trovato A, Miceli N, Monforte MT. Biological effect of Opuntia ficus indica (L.) Mill.

(Cactaceae) waste matter. Note I: diuretic activity. J Ethnopharmacol. 2002;79(1):17-21.

Perfumi M, Tacconi R. Effect of Opuntia ficus-indica flower infusion on urinary and electrolyte excretion in rats.

Fitoterapia. 1996;67(5):459-464.

Tesoriere L, Butera D, D'Arpa D, Di Gaudio F, Allegra M, Gentile C, Livrea MA. Increased resistance to oxidation of

betalain-enriched human low density lipoproteins. Free Radic Res. 2003;37(6):689-696.

Tesoriere L, Allegra M, Butera D, Livrea MA. Absorption, excretion, and distribution of dietary antioxidant betalains

in LDLs: potential health effects of betalains in humans. Am J Clin Nutr. 2004a;80(4):941-945.

Tesoriere L, Butera D, Pintaudi AM, Allegra M, Livrea MA. Supplementation with cactus pear (Opuntia ficus-indica)

fruit decreases oxidative stress in healthy humans: a comparative study with vitamin C. Am J Clin Nutr.

2004b;80(2):391-395




To know more, feel free to contact us :

Bio Serae Laboratories1 Av. De la Preuilhe

11150 Bram France

[email protected]

Tel : +33 468 76 76 20

www.Cacti-Nea.com

BioSerae_Diuretic & Weight Management Significant Clinical Results_2009_v2

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