NCT07141472

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 19, 2025

Last Update Submit

August 26, 2025

Conditions

Keywords

GLP-1blood glucoseHbA1cinsulinglucagonGIPAmylin

Outcome Measures

Primary Outcomes (10)

  • fasting blood HbA1c level

    lab

    26 weeks

  • fasting blood glucose level

    lab

    26 weeks

  • fasting blood insulin level

    lab

    26 weeks

  • fasting blood GLP-1 level

    lab

    26 week

  • fasting blood glucagon level

    lab

    26 weeks

  • fasting blood GIP level

    lab

    26 weeks

  • fasting blood Amylin level

    lab

    26 weeks

  • fasting body weight

    measurement

    26 weeks

  • body fat mass

    measurement

    26 week

  • waist hip ratio

    measurement

    26 weeks

Secondary Outcomes (5)

  • satiety score

    26 weeks

  • resting metabolic rate

    26 weeks

  • Blood pressure

    26 weeks

  • Heart rate

    26 weeks

  • Energy level

    26 weeks

Study Arms (2)

Active Group who take GB

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: GB

Placebo Group

PLACEBO COMPARATOR

Placebo is a product that resemble Active product but does not contain any of the active ingredients.

Dietary Supplement: Placebo

Interventions

GBDIETARY_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.

Active Group who take GB
PlaceboDIETARY_SUPPLEMENT

Placebo is a product that resemble active GB but does not contain any of the active ingredients

Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alpine Bio

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

HyperglycemiaOverweightObesityInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Study Officials

  • Lawry Han, PhD

    Alpine Biotech

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 26, 2025

Study Start

January 7, 2025

Primary Completion

July 15, 2025

Study Completion

August 14, 2025

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations