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

N/ANot Yet RecruitingNCT07089732

Chung Shan Medical University100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Obesity Prediabetes

Interventions

GLP-1 formula liquid drinkDIETARY_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.

PlaceboDIETARY_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Chung Shan Medical University

Taichung, South, Taiwan

Outcomes

Primary Outcomes

Change from baseline in BMI at weeks 8 and 12

Assessment of changes in BMI at baseline, week 8, and week 12

Time frame: Week 0, 8 and 12

Secondary Outcomes

Change from baseline in blood glucose at weeks 8 and 12

Assessment of blood glucose changes at weeks 0, 8, and 12

Time frame: Week 0, 8 and 12

Central Contacts

Chin-Lin Hsu Professor

CONTACT

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

Data from ClinicalTrials.gov

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