Blood Sugar; High, Fat Burn, Heart Health Markers, Obesity, Overweight and Obesity
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTGLP-1 Booster (GB)
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.
Sponsors
Alpine Biotech LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Volunteers must be over the age of 18. * Volunteers cannot be smokers. * Volunteers cannot be currently taking a dietary supplement or prescription for weight loss. * Exercising volunteers must maintain their regimen consistently throughout the course of the 12-week study. * Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 12-week study. * Volunteers need to be overweight but not obese, as defined by having a BMI between 25.0 and 29.9
Exclusion criteria
* Female volunteers who are pregnant or planning to become pregnant within the next three months. * Volunteers who are taking any stimulant medications (e.g. Adderall, Adzenys, Dexedrine, Ritalin, Methylphenidate, etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| waist hip ratio | 12 week |
| body fat mass | 12 week |
| body lean mass | 12 week |
| body mass index | 12 week |
| body fat index | 12 week |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting metabolic rate | 12 week | — |
| Blood pressure | 12 week | both systolic and diastolic pressures |
| Heart rate | 12 week | — |
| Satiety score | 12 week | — |
Countries
United States
Outcome results
None listed