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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight and Obesity; Fat Burn; Blood Sugar; High; Heart Health Markers
• Intervention / Treatment: Dietary supplement: GLP-1 Booster (GB)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • Alpine Bio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GLP-1 Booster; 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 supplement: GLP-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
body mass 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
body fat mass	12 week
body lean mass	12 week
body fat index	12 week
waist hip ratio	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety score		12 week
Resting metabolic rate		12 week
Blood pressure	both systolic and diastolic pressures	12 week
Heart rate		12 week

Collaborators and Investigators

• Sponsor: Alpine Biotech LLC
• Investigators: Principal Investigator: Lawry Han, PhD, Alpine Biotech LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Obesity; Hyperglycemia
• Other Study ID Numbers: AB20240102H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No