LeanGard®

presented
bySabinsa Corporation*Composition containing:
ForsLean®
GarCitrin®
BioPerine®

*Trademarks & Patented Ingredients of Sabinsa Corporation

Synergistic Weight Management Formula
ForsLean®

GarCitrin®

(Coleus forskohlii extract, 10% forskolin):(Garcinia cambogia Extract):

Forskolin helps build

LeanGard®

Hydroxycitric acid inlean body mass and maintaincombination withhealthy body composition

garcinol supports satiety

through cAMP mediatedand weight loss throughactioncitrase lyase inhibition
BioPerine®
(Piper nigrum Extract):

Enhances uptake and utilization of thenatural actives listed above

LeanGard®
LeanGard® is a proprietary blend of natural extracts that supports healthy body composition andweight management. The constituents are ForsLean® (a patented* natural extract from the roots of Coleus
forskohlii (standardized to contain 10% forskolin), GarCitrin® (a natural extract from Garcinia cambogia
fruit containing hydroxycitric acid and garcinol, and BioPerine® (a natural extract from black pepper fruit, abioavailability enhancer).

ForsLean®
ForsLean® is clinically proven to effect enhanced lean body mass and support healthy bodycomposition1. Epidemiological studies indicate that the impact of body composition on health starts early inlife2. In a separate study, it was found that being overweight in adolescence predicted a broad range ofadverse health effects that were independent of adult weight after 55 years of follow-up3.

Forskolin is known as a compound with versatile biological actions based on its ability to stimulate
adenylate cyclase and cyclic AMP levels. Adenylate cyclase is the enzyme involved in the production of
Cyclic Adenosine Monophasphate (cAMP), (a significant biochemical agent that participates in metabolic
processes), from the high energy molecule, ATP(Adenosine triphosphate). Nicknamed in scientific literature
as a “second messenger”, cyclic AMP facilitates the action of “primary messengers” or various hormonal andbioactive substances in the body. The biochemical mechanism of maintaining or increasing lean body mass isrelated to the availability of cyclic AMP. By facilitating hormonal action, cyclic AMP may regulate the
body's thermogenic response to food, increase the body's basic metabolic rate, and increase utilization ofbody fat (since thermogenesis is preferentially fueled by fatty acids derived from body fat and/or food).

Typically, an increase in cyclic AMP leads to subsequent activation of protein kinase. Protein kinasehas been shown to activate the hormone sensitive lipase which is involved in the breakdown of triglycerides,
known as building blocks of fatty tissue1.

*

US Patent 5,804,596© 2004-2007 Sabinsa Corporation2

Forskolin may also be involved in regulating insulin secretion3. Insulin, although well recognized forits metabolism of carbohydrates, is also involved in the metabolism of fats and proteins that are major
contributors to body composition.
Clinical studies in India, Japan and USA have revealed the efficacy of ForsLean® in reducing bodyweight and body fat and thereby enhancing lean body mass1,10.
ForsLean® Study Abstracts

Badmaev V, Majeed M, Conte A, Parker JE (2000)
Diterpene forskolin (Coleus forskohlii, Benth.): A Possible new compound for reduction ofbody weight by increasing lean body mass
An extract of Coleus forskohlii root, Benth. (Fam. Labiatae) standardized for diterpene forskolin(ForsLean®) was tested in an open-field study for weight loss and lean body mass increase. The study’s
hypothesis was based on the recognized role of diterpene forskolin as a plant derived compound, which
stimulates enzyme adenylate cyclase and subsequently cyclic AMP (3’5’adenosine monophosphate). Cyclic
AMP may release fatty acids from the adipose tissue depots which may result in enhanced thermogenesis,
loss of body fat, and theoretically increased lean body mass.

Six overweight, but otherwise healthy, women were selected for the trial. Each participant was
informed about the purpose of the study and was asked to sign an informed consent before entering the study.
Each participant was examined by a physician at the inception and after 4 and 8 weeks of the study. Theirbody composition was determined by bioelectrical impedance analysis. ForsLean was prepared in the formof two-piece hard shell capsules. Each capsule contained 250 mg of the extract standardized for 10%
forskolin. Participants were instructed to take one capsule in the morning and one in the evening, half anhour before a meal. Participants were asked to maintain their previous daily physical exercise and eating
habits. In addition, physical activity was monitored based on a questionnaire before and during the trial. The
study was performed in an outpatient bariatric clinic at Hilton Head, S.C. and supervised by a physician
specializing in bariatric medicine for over 30 years.

© 2004-2007 Sabinsa Corporation3

During the eight week trial the mean values for body weight, and fat content were significantly
decreased, whereas lean body mass was significantly increased as compared to the baseline (Wilcoxon
matched pairs test). Weight loss was statistically significant (p<0.05) after 4 and 8 weeks, and the meanamounted to 4.3 and 9.17 lbs respectively. The body fat values expressed as % body fat were: 0 weeks 33.63± 3.02, 4 weeks 30.10 ± 4.34 (statistically not significant or n.s.), and 8 weeks 25.88 ± 4.77 (p<0.05). The
lean body mass values expressed as % lean body mass were: 0 weeks 67.07 ± 3.02, 4 weeks 69.90 ± 4.34
(n.s.), and 8 weeks 74.13 ± 4.77 (p<0.05). (Figure 1).

The eight-week therapy with 50 mg of forskolin per day did not adversely affect the systolic/diastolicblood pressure or the pulse rate. However, a trend was observed to lower the systolic/diastolic pressure in
the course of treatment. Systolic pressure (mm Hg) was 0 weeks 113.67 ± 14.50, 4 weeks 110.00 ± 18.93(n.s.), and 8 weeks 104.50 ± 17.54(n.s.). Diastolic pressure (mmHg) was 0 weeks 71.00 ± 12.76, 4 weeks
69.33 ± 9.93 (n.s.), and 8 weeks 66.00 ± 8.49(n.s.). Pulse rate (beats/min) was 0 weeks 66.33 ± 8.02, 4 weeks
69.00 ± 7.97(n.s.), and 8 weeks 74.67 ± 11.55(n.s.).

10Meanweight loss
(lbs)

8
6

%

4
2

Mean bodyfat (%)

0
-2
-4
-6
-8
-10

Mean leanbody mass(%)

Figure 1: Open field study, 6 overweight women subjects, 500 mg ForsLean® corresponding to 50 mg
forskolin/day for 8 weeks© 2004-2007 Sabinsa Corporation

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This preliminary data obtained with 250 mg bid of ForsLean® 10% extract indicate that thiscomposition bears promise as a safe and effective weight loss regimen. The effect of ForsLean® isparticularly valid in the absence of change in frequency and intensity of physical exercise and without diet
restrictions during the course of the trial. This study warrants a double-blind clinical trial evaluating effects
of forskolin on body composition and its possible thermogenic mechanism.

Asano Tsuguyoshi (2001)
Clinical report on root extract of Coleus forskohlii ForsLean® in reducing body fat
Asano Institute. Tokyo, JapanA standardized extract of Coleus forskohlii roots known as ForsLean® (10% diterpene forskolin) was
evaluated in a 12 week open field study in overweight volunteers, 1 male and 13 females; average weight
74.7±11.98 kg, average BMI 29.9±4.31 and average body fat 38.2±4.87%. ForsLean® was administered in adose of 125 mg twice a day. Total daily intake of ForsLean® was calculated as 25 mg of diterpene forskolin.
Each patient was examined in the physician’s office and body composition measurements were taken with an
infrared analyzer Futurex 6200 on day 0, first month, second month and third month. Total body weight
showed tendency to decrease from an average 74.7 kg at the onset of the study to 73.5 kg on the third month(p<0.05). Body mass index improved from an initial average value of 29.9 to 29.4 (p<0.05) at conclusion of
the study. The body fat was decreased from an initial average value of 38.2% to 37.1% (p<0.01) atconclusion of the study. Lean body mass was preserved in the course of 12 week ForsLean® administration(average 45.8 kg vs. 45.9 kg). The 12-week regimen with 25 mg of forskolin per day did not significantly
change blood pressure parameters, i.e. average systolic blood pressure 135.7 mmHg vs. 128 mmHg; average
diastolic blood pressure 85.3 mmHg vs. 83.6 mmHg. This 12 week open field study of ForsLean® on 14
overweight Japanese subjects indicates its usefulness in weight loss management with no apparent subjective
and objective side effects of the regimen.

© 2004-2007 Sabinsa Corporation

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Krieder R et al. (2002)
Effects of Coleus forskohlii extract supplementation on body composition and markers of healthin sedentary overweight female
In a double blind and randomized manner, 23 females supplemented their diet with ForsLean® (250
mg of 10% Coleus forskohlii [CF] extract, n=7) or a placebo (n=12) two times per day for 12 weeks. Body
composition (DEXA), body weight, and psychometric instruments were obtained at 0, 4, 8 & 12 weeks ofsupplementation. Fasting blood samples and dietary records (4-d) were obtained at 0 and 12 weeks. Side
effects were recorded on a weekly basis. Data were analyzed by repeated measures ANOVA and arepresented as mean changes from baseline for the CF and placebo groups, respectively. No significant
differences were observed in caloric or macronutrient intake. CF tended to mitigate gains in body mass (0.7±1.8, 1.0±2.5 kg, p=0.10) and scanned mass (-0.2±1.3, 1.7±2.9 kg, p=0.08) with no significant differencesin fat mass (-0.2±0.7, 1.1±2.3 kg, p=0.16), fat free mass (-0.1±1.3, 0.6±1.2 kg, p=0.21), or body fat (-0.2±1.0,
0.4±1.4 %, p=0.40). Subjects in the CF group tended to report less fatigue (p=0.07), hunger (p=0.02), andfullness (p=0.04). No clinically significant interactions were seen in metabolic markers, blood lipids, muscle
and liver enzymes, electrolytes, red cells, white cells, hormones (insulin, TSH, T3, and T4), heart rate, bloodpressure, or weekly reports of side effects. Results suggest that CF may help mitigate weight gain in
overweight females with apparently no clinically significant side effects.

Bhagwat, A.M. et al (2004)
A Randomized Double-Blind Clinical Trial to Investigate The Efficacy and Safety of ForsLean in
Increasing Lean Body Mass
Shri C. B. Patel Research Center for Chemistry and Biological Sciences, Mumbai, India.
In a 12 week double blind and randomized study, 60 obese male and female volunteers, 25 – 45 years
old with a Body Mass Index (BMI) between 28 – 40 and / or body fat concentration above 30% in males and
40% in females received 25 mg of diterpene forskolin bid in the form of ForsLean® (250 mg of 10% Coleus
forskohlii roots extract) or a matching placebo. The volunteers receiving the ForsLean® on average lost 3.81
pounds or 2.3% of their total body weight, while the placebo group gained an average one half pound or
0.3% of the total body weight. The volunteers treated with the placebo gained 0.32% of body fat, while theForsLean receiving group lost 0.87% of body fat. The difference in the weight and fat reduction was© 2004-2007 Sabinsa Corporation

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statistically significant between the active and placebo groups. The thyroid function tests were performed,
assessing levels of hormones T3, T4 and TSH before and after the completion of the study. It was observedthat the levels of all three hormones remained within normal range in both active and placebo treated groups
after 12 weeks of the regimen. The blood lipid profile, performed at the onset and at the conclusion of thestudy, included triglycerides, total cholesterol, HDL, LDL and VLDL. Ratio of total cholesterol to HDL wasalso calculated. At the end of 12 weeks, the placebo treated volunteers did not show any significant change
in any of the lipid parameters recorded. However, those volunteers on the active compound showed asignificant rise in the concentrations of HDL at the end of the study, while triglycerides, total cholesterol,
LDL and VLDL levels remained unchanged in this group as compared to baseline and placebo group levels.
In conclusion, based on this 12 week clinical study ForsLean® may have a weight and fat reduction
property. In addition, as compared with the placebo receiving group, ForsLean® may help preserve leanbody mass. The 12-week treatment did not produce any subjective or objective side effects in either theactive compound or placebo-receiving group. The laboratory data indicate that ForsLean® regimen did notalter the thyroid hormones and blood lipid profile, with exception of increase in the HDL serum levels andsignificant decrease of total cholesterol/HDL ratio as compared to the control group.

Kamath, M.S. et al (2004)
Efficacy and safety in increasing lean body mass in class I obese subjects
Kasturba Medical College, Manipal, India
50 subjects, male and female, were randomized to receive 250 mg of ForsLean® or Placebo capsules
twice a day (morning and evening) half an hour before meals for 12 weeks. Significant decrease in bodyweight and fat content and significant increase in lean body mass was observed. (Figure 2)© 2004-2007 Sabinsa Corporation

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Figure 2: Mean Change in Lean Body Mass, Fat Content and Body Weight (n=50)

GarCitrin®
GarCitrin® is clinically proven to enhance lean body mass and support healthy body composition10.
GarCitrin® is a patent pending product combining the weight management benefits of hydroxycitric acid withthe bioavailability-enhancing effects of garcinol, a polyisoprenylated benzophenone isolated from Garcinia
cambogia and Garcinia indica. Garcinol enhances the biological action of HCA and contributes antioxidant
activity to the formulation.
Citrin®** products from Sabinsa Corporation are standardized to contain a minimum of 50%
hydroxycitric acid(-HCA) as salts of nutritionally essential minerals including calcium, potassium, andmagnesium.

The potential of (-) HCA as a weight-lowering compound has been recognized since the 1970's, andis supported by clinical data4-8. However, clinical studies have sometimes shown inconclusive data9, most
likely due to poor bioavailability of HCA in the cytosol of target cells. A high-fiber diet is thought to reduce**

US Patent 5,783,603© 2004-2007 Sabinsa Corporation

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the absorption of HCA. Because its efficacy in inhibiting ATP citrate lyase depends entirely on the presenceof HCA inside the target cell, reduced HCA absorption would decrease its weight-lowering effects.

Garcinol is a polyisoprenylated benzophenone derived from Garcinia species. Garcinol is known tobe an antioxidant (emulsified garcinol suppresses superoxide anion similarly to DL-alpha-tocopherol), anticarcinogen and antimicrobial. Garcinia cambogia (Malabar tamarind, brindall berry) and Garcinia indica(kokum) have a history of traditional culinary use in India.

The efficacy and safety of the combination of (-) HCA and garcinol in supporting healthy bodycomposition and weight management is supported by clinical data.10 The combination consisting of 500 mg
of calcium salt of HCA and 25 mg of garcinol (NC) was evaluated in a double-blind 12 weeks clinicalstudy against the formula containing 500 mg of calcium salt HCA (C). The study was carried on 46
overweight female volunteers (BMI greater than 25). Participants were instructed to take one capsule ofeither active or placebo formula three times a day, half an hour before a meal. Each participant was asked tomaintain her previous daily physical exercise and eating habits. In addition, physical activity was monitored
based on a questionnaire before and during the trial. The participants were evaluated at the baseline, weeks 2,
4, 6, 8, 10 and 12. The following clinical parameters were evaluated at each visit: total body weight (Figure3), body composition by the bioelectric impedance method, self-assessed appetite and energy levels, pulse
rate and blood pressure. During the 12 week trial, the mean values in group NC for body weight and fat
content significantly decreased, whereas lean body mass and total body water significantly increased
compared to the baseline values and C group values. The appetite levels were significantly less in the NC
group than the C group, whereas energy levels were equally increased in both study groups as compared tothe baseline. No subjective or objective adverse effects were reported in the course of this study. The pulse
rate, systolic and diastolic blood pressure were maintained at the same level throughout the study10.

© 2004-2007 Sabinsa Corporation

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2.5

WEIGHT LOSS

2.0

1.5

1.0

0.5

0.0
group
group

2

4

6

8

10

12

0.06
1.03

0.23
1.36

1.01
1.44

1.22
2.03

1.13
2.31

1.37
1.99

Figure 3: Effect of the two formulations on weight loss

BioPerine®
BioPerine® is a bioavailability enhancer. BioPerine® is a patented*** standardized piperine extract
obtained from the fruits of the Piper nigrum L. (black pepper) and/or Piper longum L. (long pepper) plantsthat are cultivated in the damp, nutrient-rich soil regions of south India. The delicate pepper berries are hand
harvested just prior to ripening and then sun dried to assure optimum maturity and quality.
BioPerine®, has been clinically tested with several nutrient groups including fat soluble vitamins(beta-carotene) , water soluble vitamins (vitamin B6, vitamin C), selenoamino acid (L(+)-Selenomethionine),
Coenzyme Q10 and shown to significantly enhance the bioavailability of supplemented nutrients throughincreased absorption11. Herbal extracts such as curcumin are also absorbed better when co-administered with
BioPerine®11.
Thus LeanGard® represents a bioavailable composition of natural extracts with clinically provenefficacy and documented safety in supporting healthy body composition and weight management.
***

US Patents 5,536,506 5,744,161 5,927,382 6,054,585 and international patents© 2004-2007 Sabinsa Corporation

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References:1.

www.forslean.com

2.

Stevens, J. et al. (1998) The body mass index-mortality relationship in white and African American
women. Obes. Res., 6(4):268-77

3.

Must, A. (1996) Morbidity and mortality associated with elevated body weight in children andadolescents. Am. J. Clin. Nutr. 63(3 Suppl):445S-4447S

4.

Conte A.A. A Non-Prescription Alternative in Weight Reduction Therapy. The Bariatrician. 1993:
17-19.

5.

Conte A.A. The effects of (-) - Hydroxycitrate And Chromium (GTF) On Obesity. J Amer Coll Nutr.
1994 (October);13 (5): 535 [Abstract 60].

6.

Katts GR, Pullin D, Parker LK, Keith PL, Keith S. Reduction Of Body Fat As A Function Of Taking
A Dietary Supplement Containing Garcinia Cambogia Extract, Chromium Picolinate And L-Carnitine- A Double Blind Placebo Controlled Study. Abstract/Poster presented at a symposium on obesityorganized by the Mexican Sociedad Medical del Sureste para el Estudio de la Obesidad, March 4,
1995, Merida, Yucatan, Mexico.

7.

Badmaev V, Majeed M. Open Field, Physician Controlled, Clinical Evaluation Of Botanical Weight
Loss Formula Citrin(r). Nutracon 1995: Nutraceuticals, Dietary Supplements And Functional Foods.
Day One (Sponsored by Global Business Research Ltd.). Published in the symposium proceedings.

8.

Thom E. (-)Hydroxycitrate (HCA) In The Treatment Of Obesity. Int J Obesity. 20 (4): 75 [Abstract/Poster 08-193-WP1 at 7th European Congress on Obesity in Barcelona, Spain 14-17 May, 1996].

9.

Heymsfield SB, Allison DB, Vasselli JR, Pietrobelli A, Greenfield D, Nunez C. Garcinia cambogia(hydroxycitric acid) as a potential antiobesity agent: a randomized controlled trial. JAMA.
1998;280:1596-1600.

10.

Badmaev V and Majeed M. Paper presented at the Annual Meeting of the Institute of Food
Technologists Las Vegas, NV, July 14, 2004.

11.

www.bioperine.com

LeanGard® is a propriety blend covered by these ingredient patents from Sabinsa Corporation, aleading manufacturer & global supplier of fine nutritional ingredients.
ForsLean® : U.S.A.: 5,804,596
GarCitrin®: U.S.A.: 7,063,861; AU773081; EP1254209; NZ518116
BioPerine® : U.S.A.: 5,536,506; 5,744,161; 5,972,382; 6,054,585; EP0810868
These claims have not been approved by the FDA and these products are not intended to diagnose, cure, or treat any disease.

© 2004-2007 Sabinsa Corporation

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