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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 The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.
SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP-1 Booster | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 Booster (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 |
|---|---|---|
| blood glucose level | 12 week | |
| blood HbA1c level | 12 week | |
| blood insulin level | 12 week | |
| blood GLP1 level | 12 week | |
| blood cholesterol level | 12 week | |
| body weight | 12 week | |
| body fat mass | 12 week | |
| body lean mass | 12 week | |
| body mass index | 12 week | |
| body fat index | 12 week | |
| waist hip ratio | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety score | 12 week | |
| Resting metabolic rate | 12 week | |
| Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawry Han, PhD | Alpine Biotech LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alpine Bio | Salt Lake City | Utah | 84109 | United States |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
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|
both systolic and diastolic pressures
| 12 week |
| Heart rate | 12 week |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |