Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans

Not Applicable

Completed

• Conditions: Blood Sugar; High; Overweight and Obesity; Fat Burn; Obesity; Heart Health Markers
• Interventions: Dietary Supplement: GLP1 Booster (GB)

• Registration Number: NCT06333496
• Lead Sponsor: Alpine Biotech LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-02
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-03-27
• Primary Completion: 2024-03-29
• Study Completion: 2024-05-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLP-1 Booster	GLP1 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, White kidney bean (Phaseolus vulgaris) extract, berberine (from Berberis aristata bark extract),and chromium (III) an essential trace mineral. Each of these ingredients has been commonly consumed by humans as food sources or supplements and thus has an undebatable safety profile.

Primary Outcome Measures

Name	Time	Method
blood insulin level	12 week
blood HbA1c level	12 week
body fat index	12 week
blood glucose level	12 week
blood GLP1 level	12 week
blood cholesterol level	12 week
body weight	12 week
waist hip ratio	12 week
body fat mass	12 week
body lean mass	12 week
body mass index	12 week

Secondary Outcome Measures

Name	Time	Method
Resting metabolic rate	12 week
Blood pressure	12 week	both systolic and diastolic pressures
Heart rate	12 week
Satiety score	12 week

Trial Locations

Locations (1)

Alpine Bio; 🇺🇸 Salt Lake City, Utah, United States