Effects of a Glucagon-like Peptide-1 (GLP-1) Booster™ on Blood Glucose, HbA1c, Insulin, Glucagon, GLP-1, GIP, and Amylin Levels, Body Weight and Body Fat in Overweight Adult Men and Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- fasting blood GLP-1 level
Study Overview
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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Volunteers must be over the age of
- •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 26-week study.
- •Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 26-week study.
- •Volunteers need to be overweight but not obese, as defined by having a BMI between 25.0 and 29.9
Exclusion Criteria
- Not provided
Arms & Interventions
Active Group who take 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.
Intervention: GB (Dietary Supplement)
Placebo Group
Placebo is a product that resemble Active product but does not contain any of the active ingredients.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
fasting blood GLP-1 level
Time Frame: 26 week
lab
fasting blood HbA1c level
Time Frame: 26 weeks
lab
fasting blood glucose level
Time Frame: 26 weeks
lab
fasting blood Amylin level
Time Frame: 26 weeks
lab
fasting blood insulin level
Time Frame: 26 weeks
lab
fasting blood glucagon level
Time Frame: 26 weeks
lab
fasting blood GIP level
Time Frame: 26 weeks
lab
fasting body weight
Time Frame: 26 weeks
measurement
body fat mass
Time Frame: 26 week
measurement
waist hip ratio
Time Frame: 26 weeks
measurement
Secondary Outcomes
- satiety score(26 weeks)
- resting metabolic rate(26 weeks)
- Blood pressure(26 weeks)
- Heart rate(26 weeks)
- Energy level(26 weeks)
- satiety score(26 weeks)
- resting metabolic rate(26 weeks)
- Blood pressure(26 weeks)
- Heart rate(26 weeks)
- Energy level(26 weeks)
Investigators
Lawry Han
Principal Investigator
Alpine Biotech LLC