Effects of GLP-1 Formula on GLP-1 and Glucose Regulation

NCT07082062 | Recruiting

• 1 other identifier: CS2-24173
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is designed to evaluate the physiological effects of a GLP-1 Formula on glucagon-like peptide-1 (GLP-1) secretion and glycemic regulation in adults with elevated body fat percentage. The GLP-1 Formula is a multi-component dietary supplement composed of Bifidobacterium breve (probiotic), ClpB Formula-a prebiotic blend containing probiotic kombucha extract, soy peptide powder, L-arabinose, and erythritol-and rocket apple extract. The study consists of two randomized crossover trials: Trial 1 (n = 50) aims to assess the effects of the formula on circulating GLP-1 concentrations, while Trial 2 (n = 50) investigates its impact on blood glucose and insulin responses. Eligible participants will be healthy adults aged 18 to 50 years with a body fat percentage greater than 25%, recruited via institutional and online outreach. Participants may choose to enroll in either or both trials; if enrolled in both, a washout period of at least one month between trials is required. Each trial consists of two intervention visits following a crossover design, with supplementation switched on day 8. Each visit will last approximately 6 hours, during which physiological and biochemical assessments will be conducted. Primary outcome measures include plasma levels of GLP-1, glucose, and insulin; secondary outcomes include appetite-related indices. This study aims to elucidate the potential of this functional formula to modulate incretin response and glycemic homeostasis in individuals with elevated adiposity.

Conditions

Overweight

Keywords

Probiotic; Prebiotic; Glucagon-like peptide-1 (GLP-1); Blood glucose; Insulin

Outcome Measures

Primary Outcomes (3)

• Plasma GLP-1 concentration (pmol/L)

  Plasma GLP-1 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the GLP-1 Formula on Days 1 and 7.

  Day 1 and Day 7

• Blood glucose concentration (mg/dL)

  Blood glucose levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the GLP-1 Formula on Days 1 and 7.

  Day 1 and Day 7

• Serum insulin concentration (μIU/mL)

  Serum insulin levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the GLP-1 Formula on Days 1 and 7.

  Day 1 and Day 7

Study Arms (2)

Control group

NO INTERVENTION

Participants in the control group will consume 100 mL water

GLP-1 formula Group

EXPERIMENTAL

Participants in the intervention group will consume a single dose of GLP-1 formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract.

Dietary Supplement: GLP-1 formula Group

Interventions

GLP-1 formula Group DIETARY_SUPPLEMENT

Participants in the intervention group will consume a single dose of GLP-1 formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract. The ClpB formula consists of kombucha, soy peptide powder, L-arabinose and erythritol.

Also known as: Bifidobacterium breve, ClpB formula consists of kombucha, soy peptide powder, L-arabinose and erythritol., Rocket Apple extract

GLP-1 formula Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants aged 18-50 years with a body fat percentage greater than 25%.

You may not qualify if:

• Use of probiotics, weight loss products, or gastrointestinal health-related supplements or medications within the past month.
• Presence of diabetes, autoimmune diseases, cancer, chronic gastrointestinal disorders, lactose intolerance, or chronic diarrhea.
• History of gastrointestinal surgery.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Shih Chien Huang: lead
• TCI Co., Ltd.: collaborator

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

RECRUITING

MeSH Terms

Conditions

Overweight; Insulin Resistance

Interventions

Arabinose; Erythritol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pentoses; Monosaccharides; Sugars; Carbohydrates; Sugar Alcohols; Alcohols; Organic Chemicals

Study Officials

• Shih-Chien Huang, PhD, Associate Professor

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Chien Huang, PhD, Associate Professor

CONTACT

+886424730022; schuang@csmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Assistant Professor

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 24, 2025
• Study Start: June 2, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)