Below you will find a list of the ingredients in Lean System 7 and relevant clinical studies.
If you have not already done so, you may want to click here to read general
information about Lean System 7.
Yerba mate
Andersen, T., and Fogh, J., "Weight Loss and Delayed Gastric Emptying Following a
South American Herbal Preparation in Overweight Patients," J Hum Nutr
Diet 14.3 (2001) : 243-50.
Guarana
Andersen, T., and Fogh, J., "Weight Loss and Delayed Gastric Emptying Following a South
American Herbal Preparation in Overweight Patients," J Hum Nutr Diet 14.3 (2001) : 243-50.
Citrus Aurantium
Colker, CM., et al. "Effects of Citrus aurantium Extract, Caffeine, and St. John's Wort
on Body Fat Loss, Lipid Levels, and Mood States in Overweight Healthy
Adults," Curr Ther Res 60 (1999) : 145-53.
Kalman, D.S., et al., "Effects of a Weight-Loss Aid in Healthy, Overweight Adults: Double-
Blind, Placebo-Controlled Clinical Trial," Curr Ther Res Clin Exper 61.4 (2000) : 199-205.
Coleus forskohlii
Sabinsa Corporation Research
7-Keto
Kalman, D.S., et al., "A Randomized, Double-Blind, Placebo Controlled Study
of 3-Acetyl-7-Oxo-Dehydroepiandrosterone in Healthy Overweight Adults," Curr Ther
Res 61.7 (2000) : 435-42.
Colker, C., et al., "Double-Blind, Placebo-Controlled, Randomized Clinical Trail Evaluating
the Effects of Exercise Plus 3-Acetyl-7-Oxo-Dehydroepiandrosterone on Body Composition
and the Endocrine System in Overweight Adults," J Exer Physiol Online 2.4 (1999).
Bioperine
Badmaev, V., et al., "Piperine Derived from Black Pepper Increases the Plasma Levels
of Coenzyme Q10 Following Oral Supplementation J Nutr Biochem 11.2 (2000) : 109-13.
Detailed Information on the Studies Cited Above:
Weight Loss and Delayed Gastric Emptying Following a South American Herbal Preparation in
Overweight Patients. Andersen, T. and Fogh J. J Hum Nutr Diet 14(3): 243-50 2001
BACKGROUND:
Obesity and overweight may soon affect more than half of the population in some regions of the world and are associated with diabetes, hypertension, and other diseases that cause morbidity, mortality, and high health-care expenditure. No one approach, whether dietetic management, medication, or commercial weight-loss program, can alone solve the problem - all potential treatments need to be investigated and exploited. Among the herbal preparations known to non-western cultures are materials which may have applications in modulating physiological processes which influence gut motility, food intake, and energy balance. One such mixed herbal preparation is "YGD" containing Yerbe mate (leaves of Ilex paraguayenis), guarana (seeds of Paullinia cupana), and damiana (leaves of Turnera diffusa var. aphrodisiaca).
AIMS:
This study had two distinct aims: to determine the effect of a herbal preparation "YGD" containing Yerbe mate, guarana and damiana on gastric emptying; to determine the effect of the same preparation on weight loss over 10 days and 45 days and weight maintenance over 12 months.
METHODS:
Gastric emptying was observed using ultrasound scanning in seven healthy volunteers following YGD and placebo capsules taken with 420 ml apple juice. Body weight was observed before and after 10 days of treatment with three YGD capsules or three placebo capsules before each meal for 10 days in 44 healthy overweight patients attending a primary health-care center. Forty-seven healthy overweight patients entered a double-blind, placebo-controlled parallel trial of three capsules of YGD before each main meal for 45 days compared with three placebo capsules. Bodyweight was monitored in 22 patients who continued active (YGD capsules) treatment for 12 months.
RESULTS:
The herbal preparation YGD was followed by a prolonged gastric emptying time of 58 +/- 15 min compared to 38 +/- 7.6 min after placebo (P = 0.025). Bodyweight reductions were 0.8 +/- 0.05 kg after YGD capsules compared to 0.3 +/- 0.03 kg after placebo capsules over 10 days and 5.1 +/- 0.5 kg after PGD capsules compared to 0.3 +/- 0.08 kg after placebo over 45 days. Active treatment with YGD capsules resulted in weight maintenance of the group (73 kg at the beginning and 72.5 kg at the end of 12 months).
CONCLUSIONS:
The herbal preparation, YGD capsules, significantly delayed gastric emptying, reduced the time to perceived gastric fullness, and induced significant weight loss over 45 days in overweight patients treated in a primary health-care context. Maintenance treatment given in an uncontrolled context resulted in no further weight loss, nor weight regain in the group as a whole. The herbal preparation is thus shown to be one that significantly modulates gastric emptying. Further clinical studies with dietetic monitoring of energy intake, dietary quality, satiety ratings, bodyweight, and body composition are now indicated, and examination of the active principles contained in the three herbal components may prove rewarding.
Weight loss and delayed gastric emptying following a South American herbal preparation in overweight patients.
Effects of Citrus aurantium Extract, Caffeine, and St. John’s Wort on Body Fat Loss,
Lipid Levels, and Mood States in Overweight Healthy Adults. Colker, C.M., Kalman, D.S.,
Torina, G.C., Perlis, T., and Street, C. Current Therapeutics 60.3(1999):145-53.
The purpose of this study was to determine the effects of Citrus aurantium extract
(an indirect beta-sympathicomimetic agent), caffeine, and St. John's wort on body composition, metabolic
variables, plasma lipid levels, and mood states in overweight healthy adults. In a double-masked,
randomized, placebo-controlled study, 23 subjects with a body-mass index > 25 kg/m2 were assigned to
1 of 3 groups. Group A received C aurantium extract 975 mg, caffeine 528 mg, and St. John's wort
900 mg daily; group B received a maltodextrin placebo; and group C received nothing and served
as the control group. For 6 weeks, subjects were instructed by a registered dietician on
how to follow an 1,800-kcal/d American Heart Association Step One diet and performed
a 3-day/week circuit training exercise program under the supervision of an exercise physiologist.
During the exercise sessions, subjects achieved approximately 70 percent of age-predicted maximum
heart rate. Compared with subjects in the placebo and control groups, subjects in the treatment
group lost a significant amount of body weight (1.4 kg). They also lost a significant amount of
body fat (an average change of 2.9 percent). In terms of actual fat loss, group A lost a
significant amount (3.1 kg), whereas the control group demonstrated a tendency toward fat
loss. No significant changes were noted in the results of the Profile of Mood States
questionnaire for fatigue or vigor in any of the three groups. Group A experienced a decrease,
which did not reach statistical significance, of both plasma cholesterol and triglycerides.
No significant changes in blood pressure, heart rate, electrocardiographic findings, serum
chemistries, or urinalysis findings were noted in any of the groups. Based on these results,
it was concluded that the combination of C aurantium extract, caffeine, and St. John's wort
is safe and effective when combined with mild caloric restriction and exercise for
promoting both bodyweight and fat loss in healthy overweight adults.
Effects of a Weight-Loss Aid in Healthy Overweight Adults: Double-Blind, Placebo-Controlled
Clinical Trial. Kalman, D.S, Colker, C.M., Kalman, D.S., Shi, Q., and Swain, M. A.
Current Therapeutic Research Clinical and Experimental 61.4(2000):199-205.
Objective:
This study was undertaken to determine the effects of an ephedrine- and synephrine-based compound on body mass, body composition, metabolic variables, and mood states in healthy overweight adults.
Methods:
Thirty subjects with a body mass index of >27 kg/m2 were assigned randomly to the experimental group or the placebo group. The experimental group received a capsule containing ephedrine alkaloids 20 mg, synephrine 5 mg, caffeine 200 mg, and salicin 15 mg twice daily for 8 weeks, whereas the other group received a matching placebo. A registered dietician instructed all patients about a 22-kcal/kg National Cholesterol Education Program Step One diet. In addition, all patients performed a cross-training exercise program 3 days per week under the guidance of an exercise physiologist. During the exercise sessions, patients achieved appoximately 70 percent of age-predicted maximum heart rate.
Results:
The experimental group had a significantly greater weight loss compared with the placebo group (3.14 kg vs 2.05 kg, respectively; P < 0.05). The experimental group experienced a 16 percent decrease in body fat compared with a 1 percent increase for the placebo group. The between-group difference was significant (P = 0.005). Both groups achieved a significant reduction in fat-free mass; however, the reduction in the placebo group was greater than that of the experimental group. This suggests a muscle-sparing effect in the experimental group. No significant changes in blood pressure, serial electrocardiograms, pulse rate, serum chemistry, or caloric intake were noted.
Conclusions:
These findings indicate the apparent safety and efficacy of the ephedrine- and synephrine-based compound within the confines of this study.
STUDY DESIGN:
ForsLean® was tested in an open-field study with a population of six overweight women (BMI
greater than 25).The tested formula was in the form of two-piece, hard-shell capsules; each
capsule contained 250 mg of the extract.
The overweight but otherwise healthy women received the forskolin formula twice daily
for eight weeks. Participants were instructed to take one capsule in the morning and
one in the evening, half an hour before a meal.
Each participant was asked to maintain her previous daily physical exercise and eating
habits. In addition, physical activity was monitored based on a questionnaire before and during the trial.
RESULTS:
During the eight-week trial, the mean values for body-weight and fat content significantly
decreased, whereas lean body mass was significantly increased compared to baseline
values (see figure below).
The regimen did not adversely affect the systolic/diastolic blood pressure nor the pulse
rate. Indeed, a trend toward lower systolic/diastolic pressure was observed during the course
of treatment.
Reference:
Research Report, Sabinsa Corporation,1999
Mechanism of action of Coleus forskohlii (as ForsLean®) in promoting lean body mass:
As mentioned previously, forskolin is known as a compound with versatile biological actions
based on its ability to stimulate adenylate cyclase and cyclic AMP levels. Typically,
an increase in cyclic AMP leads to subsequent activation of protein kinase. Protein kinase
has been shown to activate the hormone sensitive lipase, which is involved in the
breakdown of triglycerides, known as the building blocks of fatty tissue.
The other factor relevant to the weight-loss mechanism of forskolin involves its thyroid-stimulating
action, comparable in strength to thyrotropin or TSH2. The thyroid stimulating action
of forskolin may also contribute to the increase in the metabolic rate and thermogenesis. Forskolin
may also be involved in regulating insulin secretion. Insulin, although well recognized for its
metabolism of carbohydrates, is also involved in the metabolism of fats and proteins that are
major contributors to body composition.A randomized, double-blind, placebo-controlled study of 3 -
acetyl-7-oxo-dehydroepiandrosterone in healthy overweight adults
"A Randomized, Double-Blind, Placebo Controlled Study
of 3-Acetyl-7-Oxo-Dehydroepiandrosterone in Healthy Overweight Adults," Kalman, DS., Colker, CM., Swain, MA., Torina, GC., Shi, Q. Current Therapeutics, (7):435-442 2000
Objective:
The purpose of this study was to determine the effects of 3-acetyl-7-oxo-dehydroepiandrosterone (7-oxo-DHEA)
in healthy overweight adults. Methods: In a double-blind, placebo-controlled protocol,
30 adults (28 women and 2 men; mean age, 44.5 @+ 11.5 years) with a mean body mass index of 31.9 @+ 6.2 kg/m^2 were randomly divided into 2 groups of 15: Group 1 received 7-oxo-DHEA 100 mg twice daily and Group 2 received placebo for 8 weeks. All subjects participated in an exercise training program 3 times per week. Each exercise session consisted of 60 minutes of cross-training (aerobic and anaerobic exercise) under the supervision of an exercise physiologist. In addition, each subject was instructed to follow a diet of @O 1800 kcal/d (20 kcal/[kg @. d]) by a registered dietician. Subjects received biweekly dietary counselling to encourage compliance. Study participants underwent serum multiple-assay chemistry testing, as well as body composition, blood pressure, and dietary analysis at baseline, week 4, and week 8.
Results:
Of the 30 subjects who entered the study, 23 completed the 8-week protocol. Seven subjects
dropped out for personal reasons unrelated to the study. Group 1 lost a significant amount
of body weight compared with Group 2 (-2.88 kg vs -0.97 kg; P = 0.01) over the 8 weeks. Group
1 also achieved a significant reduction in body fat compared with Group 2 (-1.8% vs -0.57%; P = 0.02). The rate of change in body fat per 4-week interval in Group 1 was 3.1 times that in Group 2 (-0.88% vs -0.28%; P < 0.01). Group 1 also experienced a significant increase in triiodothyronine (T3) levels compared with Group 2 over the 8-week study period (+17.88 ng/dL vs 2.75 ng/dL; P = 0.04). There were no significant changes in levels of thyroid-stimulating hormone (TSH) or thyroxine (T4) in either group. In addition, no significant changes were observed in vital signs, blood sugar, testosterone and estradiol levels, liver and renal function, or overall caloric intake during the study. No subjective adverse effects were reported throughout the study.
Double-Blind, Placebo-Controlled, Randomized Clinical Trial Evaluating the Effects of Exercise Plus 3-Acetyl-7-oxo-dehydroepiandrosterone on Body Composition and the Endocrine System in Overweight Adults.
C Colker, M.D, G Torina, M Swain, D Kalman. Department of Medicine, Greenwich Hospital, Peak Wellness, Inc, Greenwich, CT 06830.
Journal of Exercise Physiology Online ISSN 1097-9751, Volume 2, Number 4, October 1999
3-Acetyl-7-oxo-dehydroepiandrosterone (7-Keto™) has been shown to normalize an induced hypothyroid
state in lab animals and is also known to promote futile cycling. Regular exercise is
known to help promote and maintain weight loss. Based on this information, 30 overweight (
BMI 31.9 plusmn; 6.2) adults (Age 44.5 plusmn; 11.5) were randomized into a prospective, double-
blind, placebo controlled eight week study. Fifteen subjects received 7-Keto™ 100 mg twice per
day whereas the other 15 subjects received a matching placebo. All subjects exercised three
times per week, 60 minutes per session of cross-training (aerobic and anaerobic) under the
supervision of an exercise physiologist. The exercise plus 7-Keto™ group lost a significant
amount of body weight as compared with the exercise plus placebo group (-2.88 kg, p=0.012). In
terms of actual body composition changes, the exercise plus 7-Keto™ group lost 1.8% body fat as
compared to 0.57% for the placebo group (p=0.02). In terms of effects on the thyroid,
triiodothyronine (T3) activity increased significantly in the group receiving 7-Keto™ and not
the placebo (+17.88 ng/dl vs. 2.75 ng/dl; p<0.05), there were no significant changes in either
TSH or T4. There were no significant changes in blood sugar, testosterone, estradiol, liver,
renal function tests, vital signs, or overall caloric intake over the eight week study. Nor
were there any subjective adverse effects reported throughout the study. These results indicate
that one hour of cross-training three times per week supplemented with 200 mg of 7-Keto™ per day
yields a significant reduction in both body weight and body fat.
Piperine derived from black pepper increases the plasma levels of coenzyme q10 following oral
supplementation. Badmaev, V., Majeed, M., Prakash, L. JOURNAL OF NUTRITIONAL BIOCHEMISTRY, 11(2):109-113 2000
An extract from the fruits of black pepper consisting of a minimum of 98% pure piperine was
evaluated in a clinical study using a double-blind design. The relative bioavailability
of 90 mg and 120 mg of coenzyme Q10 administered in a single-dose experiment or in separate
experiments for 14 and 21 days with placebo or with 5 mg of piperine was determined by
comparing measured changes in plasma concentration. The inter-subject variability was minimized
by limiting the selection of individuals to healthy adult male volunteers with (pre-supplementation)
fasting coenzyme Q10 values between 0.30 and 0.60 mg/L. The results of the single-dose study
and the 14-day study indicate smaller, but not significant, increases in plasma concentrations of
coenzyme Q10 in the control group compared with the group receiving coenzyme Q10 with a supplement of
piperine. Supplementation of 120 mg coenzyme Q10 with piperine for 21 days produced a
statistically significant (p = 0.0348), approximately 30% greater, area under the plasma curve
than was observed during supplementation with coenzyme Q10 plus placebo. It is postulated that
the bioenhancing mechanism of piperine to increase plasma levels of supplemental coenzyme Q10
is non-specific and possibly based on its description in the literature as a thermonutrient.
Lean System 7
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