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BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.
PURPOSE In prior study, GB was clinically shown to reduce blood sugar level, increase GLP-1 production, and help body fat loss. The purpose of this RCT study is to further assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula vs placebo, in the hope of confirming the efficacy and safety of GB.
SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, this study is a randomized controlled clinical trial for a total of 26 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints (week 0, 13 and 26).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group who take GB | Experimental | GLP-1 Booster (GB) is a composition designed to increase the endogenous production of GLP-1, improve the activity of GLP-1, enhance the body's response to GLP-1, and thus eventually help people reduce glucose, suppress food intake and lose body fat. GB contains Green tea (Camellia sinensis) leaf extract, Gardeniae (Gardenia jasminoides Ellis) fructus extract, Turmeric (Curcuma longa) root extract, Black pepper (Piper nigrum) extract,Fenugreek (Trigonella foenum-graecum) seed extract, Ginseng (Panax ginseng) root extract, and White kidney bean (Phaseolus vulgaris) extract. Each of these ingredients has been commonly consumed by humans as food sources or supplements and thus has an undebatable safety profile. |
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| Placebo Group | Placebo Comparator | Placebo is a product that resemble Active product but does not contain any of the active ingredients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB | Dietary Supplement | GLP-1 Booster (GB) is a composition designed to increase the endogenous production of GLP-1, improve the activity of GLP-1, enhance the body's response to GLP-1, and thus eventually help people reduce glucose, suppress food intake and lose body fat. GB contains Green tea (Camellia sinensis) leaf extract, Gardeniae (Gardenia jasminoides Ellis) fructus extract, Turmeric (Curcuma longa) root extract, Black pepper (Piper nigrum) extract,Fenugreek (Trigonella foenum-graecum) seed extract, Ginseng (Panax ginseng) root extract, and White kidney bean (Phaseolus vulgaris) extract. Each of these ingredients has been commonly consumed by humans as food sources or supplements and thus has an undebatable safety profile. |
| Measure | Description | Time Frame |
|---|---|---|
| fasting blood HbA1c level | lab | 26 weeks |
| fasting blood glucose level | lab | 26 weeks |
| fasting blood insulin level | lab | 26 weeks |
| fasting blood GLP-1 level | lab | 26 week |
| fasting blood glucagon level | lab | 26 weeks |
| fasting blood GIP level | lab | 26 weeks |
| fasting blood Amylin level | lab | 26 weeks |
| fasting body weight | measurement | 26 weeks |
| body fat mass | measurement | 26 week |
| waist hip ratio | measurement |
| Measure | Description | Time Frame |
|---|---|---|
| satiety score | questionnaire measuring satiety level from 1 - 10; the higher the score, the more satiety. | 26 weeks |
| resting metabolic rate | measurement |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawry Han, PhD | Alpine Biotech | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alpine Bio | Salt Lake City | Utah | 84108 | United States |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D050177 | Overweight |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
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RCT
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| Placebo | Dietary Supplement | Placebo is a product that resemble active GB but does not contain any of the active ingredients |
|
| 26 weeks |
| 26 weeks |
| Blood pressure | both systolic and diastolic pressures | 26 weeks |
| Heart rate | measurement | 26 weeks |
| Energy level | questionnaire measuring energy level from 1 - 10; the higher the score, the more energy. | 26 weeks |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |