Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals

Evaluation of the Effects of GLP-1 Formula Liquid Drink on Gut Microbiota Modulation and Blood Glucose Regulation in Prediabetic Populations

A clinical human dietary intervention trial was conducted to investigate the effects of GLP-1 FORMUL liquid supplementation in individuals with prediabetes or obesity, with a focus on improvements in glycemic and lipid parameters, body composition, and gut microbiota profiles.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Prediabetes
• Intervention / Treatment: Dietary supplement: GLP-1 formula liquid drink; Dietary supplement: Placebo

Detailed Description

This 12-week randomized, placebo-controlled clinical trial aims to evaluate the nutritional and metabolic effects of GLP-1 FORMULA liquid supplementation. A total of 100 adult participants will be recruited and randomly assigned to one of two groups: (1) placebo group (n = 50), and (2) GLP-1 FORMULA group (n = 50). Participants will consume one bottle (50 g) of either GLP-1 FORMULA or placebo 30 minutes prior to their first meal each day for 8 weeks, followed by a 4-week post-intervention observation period.

Throughout the study, participants will undergo nutritional assessments including body composition analysis, waist-to-hip ratio measurements, appetite rating scales, gastrointestinal symptom questionnaires, and the Patient Health Questionnaire. Additionally, oral glucose tolerance tests (OGTT), standard blood biochemistry analyses, and fecal sample collection will be conducted at designated time points to evaluate glycemic control, metabolic markers, and gut microbiota composition.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin-Lin Hsu Professor; Phone Number: 04-24730022 Ext. 12222; Email: clhsu@csmu.edu.tw

Study Locations

• Taiwan
  • South
    • Taichung, South, Taiwan, 402 Recruiting
      • Chung Shan Medical University
      • Contact: Chin-Lin Hsu Professor; Phone Number: 04-24730022 Ext. 12222; Email: clhsu@csmu.edu.tw

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged 18 to 70 years.
• Clinically diagnosed with prediabetes (fasting plasma glucose: 100-125 mg/dL or HbA1c: 5.7-6.4%) or with a body mass index (BMI) of 25-34.9 kg/m², male or female.
• Have not participated in similar clinical studies within the past three months.
• Able to comprehend the informed consent form, including the study procedures, potential risks, and benefits, and able to provide written informed consent.

Exclusion Criteria:

• Diagnosed with autoimmune diseases or cancer.
• Diagnosed with gastrointestinal chronic diseases such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, celiac disease, bowel control disorders, fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, ulcerative colitis, lactose intolerance, or chronic diarrhea.
• History of gastrointestinal surgery.
• Planning pregnancy in the near future (including male partners), currently pregnant, or breastfeeding women.
• Known allergy or hypersensitivity to probiotics or any of the study product ingredients.
• History of major psychiatric disorders.
• History of substance abuse or alcohol dependency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLP-1 formula liquid drink; GLP-1 formula liquid drink, 50 g/glass jar	Dietary supplement: GLP-1 formula liquid drink; One glass jar (50 g) of the GLP-1 formula liquid drink was administered once daily, 30 minutes prior to the first meal of the day.
Placebo Comparator: placebo; The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component.	Dietary supplement: Placebo; One glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in BMI at weeks 8 and 12	Assessment of changes in BMI at baseline, week 8, and week 12	Week 0, 8 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood glucose at weeks 8 and 12	Assessment of blood glucose changes at weeks 0, 8, and 12	Week 0, 8 and 12

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 8, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: July 25, 2025
• First Posted (Actual): July 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: CS2-24199

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No