Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GLP-1 formula liquid drink, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity, Prediabetes. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effects of GLP-1 Formula Liquid Drink on Gut Microbiota Modulation and Blood Glucose Regulation in Prediabetic Populations
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- Change from baseline in BMI at weeks 8 and 12 [Time frame: Week 0, 8 and 12]
Secondary outcome measures (1)
- Change from baseline in blood glucose at weeks 8 and 12 [Time frame: Week 0, 8 and 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- Chung Shan Medical University — Taichung
Identifiers
NCT: NCT07089732 · CS2-24199