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

NCT07089732 | Not Yet Recruiting

• 1 other identifier: CS2-24199
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Prediabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in blood glucose at weeks 8 and 12

  Week 0, 8 and 12

Study Arms (2)

GLP-1 formula liquid drink

EXPERIMENTAL

GLP-1 formula liquid drink, 50 g/glass jar

Dietary Supplement: GLP-1 formula liquid drink

placebo

PLACEBO COMPARATOR

The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component.

Dietary Supplement: Placebo

Interventions

GLP-1 formula liquid drink DIETARY_SUPPLEMENT

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.

GLP-1 formula liquid drink

Placebo DIETARY_SUPPLEMENT

One glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day.

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, South, 402 Recruiting, Taiwan

Location

MeSH Terms

Conditions

Obesity; Prediabetic State

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Chin-Lin Hsu Professor

CONTACT

04-24730022 Ext. 12222; clhsu@csmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 28, 2025
• Study Start: August 8, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

TW (1)