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

Obesity Clinical Trial

Official title:

Effect of a Glucagon Like Peptide 1 (GLP1) Booster on Blood Glucose, HbA1c, Insulin, and GLP1 Levels, Body Weight and Body Fat in Overweight Adult Men and Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06333496
• Other study ID #: AB20240102H
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: April 8, 2024

Study information

• Verified date: April 2024
• Source: Alpine Biotech LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: April 8, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Blood Sugar; High
• Fat Burn
• Hyperglycemia
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	Alpine Bio	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Alpine Biotech LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood glucose level		12 week
Primary	blood HbA1c level		12 week
Primary	blood insulin level		12 week
Primary	blood GLP1 level		12 week
Primary	blood cholesterol level		12 week
Primary	body weight		12 week
Primary	body fat mass		12 week
Primary	body lean mass		12 week
Primary	body mass index		12 week
Primary	body fat index		12 week
Primary	waist hip ratio		12 week
Secondary	Satiety score		12 week
Secondary	Resting metabolic rate		12 week
Secondary	Blood pressure	both systolic and diastolic pressures	12 week
Secondary	Heart rate		12 week