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Clinical Trial NCT07089732 for Obesity, Prediabetes is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals 100 Dietary
Clinical Trial NCT07089732 is an interventional study for Obesity, Prediabetes and is currently not yet recruiting. Enrollment is planned to begin on August 8, 2025 and continue until the study accrues 100 participants. Led by Chung Shan Medical University, this study is expected to complete by June 30, 2026. The latest data from ClinicalTrials.gov was last updated on July 28, 2025.
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.
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 thei...Show More
Official Title
Evaluation of the Effects of GLP-1 Formula Liquid Drink on Gut Microbiota Modulation and Blood Glucose Regulation in Prediabetic Populations
Conditions
ObesityPrediabetesOther Study IDs
- CS2-24199
NCT ID Number
Start Date (Actual)
2025-08-08
Last Update Posted
2025-07-28
Completion Date (Estimated)
2026-06-30
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGLP-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 Comparatorplacebo 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change from baseline in blood glucose at weeks 8 and 12 | Assessment of blood glucose changes at weeks 0, 8, and 12 | Week 0, 8 and 12 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- 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.
Chung Shan Medical UniversityStudy Central Contact
Contact: Chin-Lin Hsu Professor, 04-24730022 Ext. 12222, [email protected]
1 Study Locations in 1 Countries
South
Chung Shan Medical University, Taichung, South, 402 Recruiting, Taiwan
Chin-Lin Hsu Professor, Contact, 04-24730022 Ext. 12222, [email protected]