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

NCT ID: NCT07089732

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-08

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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GLP-1 formula liquid drink

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

Group Type EXPERIMENTAL

GLP-1 formula liquid drink

Intervention Type 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.

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chung Shan Medical University

Taichung, South, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Chin-Lin Hsu Professor

Role: CONTACT

04-24730022 Ext. 12222

Facility Contacts

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Chin-Lin Hsu Professor

Role: primary

04-24730022 Ext. 12222

Other Identifiers

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CS2-24199

Identifier Type: -

Identifier Source: org_study_id

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