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
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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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-08-08
2026-06-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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GLP-1 formula liquid drink
GLP-1 formula liquid drink, 50 g/glass jar
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
The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Chung Shan Medical University
OTHER
Responsible Party
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Locations
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Chung Shan Medical University
Taichung, South, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CS2-24199
Identifier Type: -
Identifier Source: org_study_id
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