Blood Sugar; High, Fat Loss, GLP-1, Glucagon, Overweight and Obesity
Conditions
Keywords
GLP-1, blood glucose, HbA1c, insulin, glucagon, GIP, Amylin
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).
Interventions
DIETARY_SUPPLEMENTGB
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.
DIETARY_SUPPLEMENTPlacebo
Placebo is a product that resemble active GB but does not contain any of the active ingredients
Sponsors
Lawry Han
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
RCT
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| waist hip ratio | 26 weeks | measurement |
| fasting blood glucagon level | 26 weeks | lab |
| fasting blood GIP level | 26 weeks | lab |
| fasting blood Amylin level | 26 weeks | lab |
| fasting body weight | 26 weeks | measurement |
| body fat mass | 26 week | measurement |
| fasting blood HbA1c level | 26 weeks | lab |
| fasting blood glucose level | 26 weeks | lab |
| fasting blood insulin level | 26 weeks | lab |
| fasting blood GLP-1 level | 26 week | lab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| resting metabolic rate | 26 weeks | measurement |
| Blood pressure | 26 weeks | both systolic and diastolic pressures |
| Heart rate | 26 weeks | measurement |
| Energy level | 26 weeks | questionnaire measuring energy level from 1 - 10; the higher the score, the more energy. |
| satiety score | 26 weeks | questionnaire measuring satiety level from 1 - 10; the higher the score, the more satiety. |
Countries
United States
Outcome results
None listed