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Clinical Trial NCT07082062 for Overweight is 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 GLP-1 Formula on GLP-1 and Glucose Regulation 100 Randomized Crossover Design Dietary
Clinical Trial NCT07082062 is an interventional study for Overweight that is recruiting. It started on June 2, 2025 with plans to enroll 100 participants. Led by Shih Chien Huang, it is expected to complete by December 31, 2025. The latest data from ClinicalTrials.gov was last updated on July 24, 2025.
Brief Summary
This clinical trial is designed to evaluate the physiological effects of a GLP-1 Formula on glucagon-like peptide-1 (GLP-1) secretion and glycemic regulation in adults with elevated body fat percentage. The GLP-1 Formula is a multi-component dietary supplement composed of Bifidobacterium breve (probiotic), ClpB Formula-a prebiotic blend containing probiotic kombucha extract, soy peptide powder, L-arabinose, and eryth...Show More
Detailed Description
This study investigates the physiological effects of a multi-component GLP-1 Formula on incretin secretion and glycemic regulation in overweight adults. GLP-1, a key incretin hormone, plays a critical role in enhancing insulin secretion, suppressing glucagon release, and reducing appetite, making it a promising target in metabolic health modulation. The GLP-1 Formula under investigation includes Bifidobacterium breve...Show More
Official Title
Exploring the Effects of GLP-1 Formula on GLP-1 Secretion and Postprandial Glucose Regulation
Conditions
OverweightOther Study IDs
- CS2-24173
NCT ID Number
Start Date (Actual)
2025-06-02
Last Update Posted
2025-07-24
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Probiotic
Prebiotic
Glucagon-like peptide-1 (GLP-1)
Blood glucose
Insulin
Prebiotic
Glucagon-like peptide-1 (GLP-1)
Blood glucose
Insulin
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionControl group Participants in the control group will consume 100 mL water | N/A |
ExperimentalGLP-1 formula Group Participants in the intervention group will consume a single dose of GLP-1 formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract. | GLP-1 formula Group Participants in the intervention group will consume a single dose of GLP-1 formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract. The ClpB formula consists of kombucha, soy peptide powder, L-arabinose and erythritol. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Plasma GLP-1 concentration (pmol/L) | Plasma GLP-1 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the GLP-1 Formula on Days 1 and 7. | Day 1 and Day 7 |
Blood glucose concentration (mg/dL) | Blood glucose levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the GLP-1 Formula on Days 1 and 7. | Day 1 and Day 7 |
Serum insulin concentration (μIU/mL) | Serum insulin levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the GLP-1 Formula on Days 1 and 7. | Day 1 and Day 7 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- Male or female participants aged 18-50 years with a body fat percentage greater than 25%.
- Use of probiotics, weight loss products, or gastrointestinal health-related supplements or medications within the past month.
- Presence of diabetes, autoimmune diseases, cancer, chronic gastrointestinal disorders, lactose intolerance, or chronic diarrhea.
- History of gastrointestinal surgery.
- Pregnant or breastfeeding women.
Shih Chien HuangTCI Co., Ltd.Study Responsible Party
Shih Chien Huang, Sponsor-Investigator, PhD, Assistant Professor, Chung Shan Medical University
Study Central Contact
Contact: Shih-Chien Huang, PhD, Associate Professor, +886424730022, [email protected]
1 Study Locations in 1 Countries
Chung Shan Medical University Hospital, Taichung, 402, Taiwan
Shih-Chien Huang, PhD, Associate Professor, Contact, +886424730022, [email protected]
Recruiting