Effects of GLP-1 Formula on GLP-1 and Glucose Regulation

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 erythritol-and rocket apple extract. The study consists of two randomized crossover trials: Trial 1 (n = 50) aims to assess the effects of the formula on circulating GLP-1 concentrations, while Trial 2 (n = 50) investigates its impact on blood glucose and insulin responses. Eligible participants will be healthy adults aged 18 to 50 years with a body fat percentage greater than 25%, recruited via institutional and online outreach. Participants may choose to enroll in either or both trials; if enrolled in both, a washout period of at least one month between trials is required. Each trial consists of two intervention visits following a crossover design, with supplementation switched on day 8. Each visit will last approximately 6 hours, during which physiological and biochemical assessments will be conducted. Primary outcome measures include plasma levels of GLP-1, glucose, and insulin; secondary outcomes include appetite-related indices. This study aims to elucidate the potential of this functional formula to modulate incretin response and glycemic homeostasis in individuals with elevated adiposity.

NCT Number	NCT07082062
Lead Sponsor	Shih Chien Huang Collaborators: TCI Co., Ltd.
Conditions	Overweight
Enrollment	100 participants
Start Date	2025-06-02
Primary Completion	2025-10-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-24