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

NCT06333496 | Completed

• 1 other identifier: AB20240102H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Sugar; High; Overweight and Obesity; Fat Burn; Obesity; Heart Health Markers

Outcome Measures

Primary Outcomes (11)

• 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 mass index

  12 week

• body fat index

  12 week

• waist hip ratio

  12 week

Secondary Outcomes (4)

• Satiety score

  12 week

• Resting metabolic rate

  12 week

• Blood pressure

  12 week

• Heart rate

  12 week

Study Arms (1)

GLP-1 Booster

EXPERIMENTAL

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)

Interventions

GLP-1 Booster (GB) DIETARY_SUPPLEMENT

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.

GLP-1 Booster

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alpine Biotech LLC: lead

Study Sites (1)

Alpine Bio

Salt Lake City, Utah, 84109, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Overweight; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lawry Han, PhD

  Alpine Biotech LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 27, 2024
• Study Start: January 2, 2024
• Primary Completion: March 29, 2024
• Study Completion: May 8, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)