Pentabosol (Metabosol) Clinical Trial Final Results Jan 16 01

Results for: Prospective, Randomized Clinical Trial for Healthy Weight Management A Study to Assess PENTABOSOL Advanced Metabolic
Research Group Incline Village, Nevada Mike Eades, MD (303) 591-1418 (cell) (888) 220-0131 (pager) (303) 247-9136 (fax) Larry McCleary, MD (303) 526-9239 (303) 526-7219 (fax) with Herbal Research, LLC, division of Marshall-Blum, LLC 304 Hancock Street Bangor, Maine 04401 (207) 990-4963 Physician Support: Peter Marshall, M.D., Bangor, Maine January 16, 2001
Design: Prospective, randomized, double-blind, placebo-controlled clinical trial The control group will receive a placebo-based product, plus the diet counseling and be asked to participate in an exercise program The duration for the trial was six weeks Equal number of subjects for both the active and placebo groups Inclusion Criteria: Subjects wishing to learn to manage their weight; subjects who answer an advertisement announcing this trial Age 18-70 Subjects who pass a compliance screening test Subjects able to tolerate the active product and placebo Subjects who sign a consent form 1
Exclusion Criteria: Subjects who are non-compliant with testing and taking treatment regimens Subjects who express problems with the treatment herbs Subjects under 18 or over the age of 70 Subjects with moderately severe co-morbid disease, that includes cardiac, pulmonary, renal, hepatic, or active cancer (this determination is subject to the study physician) Subjects with insulin-dependent diabetes Subjects on medications or other herbal preparations for the treatment of target condition Subjects with alcohol abuse as determined by liver enzyme, provider interviews, or medical history Confounding Factors: Age Prior attempts at weight management Weight or Body Mass Index Primary Outcomes: Weight Body composition measures Secondary Outcome: Blood pressure Overall well-being Diet Component: The essences of the diet will include a very-low amount of refined carbohydrates and obviously, a diet that includes fairly high percentages of fats and proteins. The carbohydrates will all be complex, mostly green vegetables. We will emphasize extremely small amounts of refined wheat products, including all breads, pasta, sugar, and the like. Each subject will be counseled about these diet concepts at two separate times prior to the initiation of the trial. Subjects will be expected to complete food logs several times during the study. The research nurse will review these logs and continue to emphasize the low carbohydrate diets with the subjects.
Exercise Program: Subjects must comply with a weekly exercise program that includes: 3 times per week for 20 minutes light-to-moderate aerobic exercises 2 times per week for 10 minutes resistance training Subjects have several options for this work: Workout on their own, using a log to record their work Light equipment at Marshall-Blum We have tailored these programs to appeal to a wide range of individuals while still meeting the exercise requirements. Protocol: Subjects will be recruited from various physician practices and from our general population. They must meet the inclusionary and exclusionary criteria and pass a compliance test. Subjects will be dropped during the study if they repeatedly fail the compliance standards. Subjects will be required to sign an informed consent, subject to the criteria set forth from Triad IRBs. The Study Coordinator will instruct subjects as to the protocol and other details of the study. Subjects will be instructed precisely how and when to take the dietary supplements during the course of this study and how to report adverse reactions and any other pertinent information. Subjects will be randomized into either the placebo or active group. The duration of the study will be six weeks. For control subjects who do not demonstrate any change after six weeks, they will be offered a six-week supply of active product. Subjects will be interviewed and screened into the study at the Marshall-Blum clinic on Hancock Street. They will receive instructions on how and when to complete the survey instruments and be given a two-week of product or placebo. They will be required to come back to the clinic every two weeks to have their blood pressure, weight, and body composition checked and will receive an additional two-week supply. This procedure will be repeated every two weeks until the study is completed. Any adverse events will be reported to Advanced Metabolic Research Group and to the Triad IRB using appropriate reporting format.
Pentabosol: Calories Total Carbohydrates 15 0.5 g Amount Per Serving Biotin Chromium (as chromium chloride) Aspartic Acid Garcinia cambogia fruit extract [50% hydroxcitrate extract] L-carnitine tartrate * Daily value has not been determined Percent based on a 2,000 calorie diet Placebo: (order based on predominance) Dextrose Natural lemon flavoring Citric acid Acesulfame potassium Silica Dosing: Two doses daily One in the morning, the second in the evening Results: There were no statistical differences between the product and placebo groups with respect to clinically important baseline and demographic parameters. This includes age, baseline weight, body mass index (bmi), behavioral variables (smoking, alcohol, caffeine, and the like), and the risk profile. This data provides evidence that the randomization worked properly and that potential selection biases were avoided. 600 mcg 400 mcg 4 grams 500 mg 10 mg % Daily Value 200% 333% * * *
Weight Loss: (numbers represent average weight loss) 2-Week 3.39, n=28 5.29, n=28 p < .069 * Indicates statistically significant weight loss Placebo Product 4-Week 4.62, n=21 7.5* , n=22 p < .048 6-Week 6.02, n=17 10.33 * , n=20 p<.025
This means that the entire group of placebo subjects lost 4.62 pounds at the four-week mark, whereas those on product lost 7.5 pounds (per subject, on average) Conclusions: The weight loss over the course of the study was strong. Those on the product lost almost twice as much weight as those on the placebo product at the six-week mark. This averaged a 1.7 pounds per week per individual on the dual regimen and 0.85 pounds over the placebo loss. Several individuals lost 18 pounds or more. Remember that physicians only recommend a weight loss program that averages no more than 1.5 to 2 pounds per week. This trial showed results at the upper level of recommended level of weight loss. If extrapolated over a 20-week period, the group would have lost 34 pounds. The results indicate that Pentabosol helps promote weight loss. To control for variability in diet and exercise both the treatment and placebo arms were maintained on an identical light exercise and dietary programs. Other findings included an improvement in cholesterol (p=.07) and triglycerides (p=.56), and 61% of product group experiencing significant appetite suppression.

Pentabosol (Metabosol) Clinical Trial Final Results Jan 16 01

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Results for: Prospective, Randomized Clinical Trial for Healthy Weight Management A Study to Assess PENTABOSOL Advanced Metabolic

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