NCT07097987

Evaluation of the Efficacy of the Composite WM Formula in Promoting GLP-1 Secretion

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: TCI Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the physiological effects of a WM Formula on glucagon-like peptide-1 (GLP-1) secretion and glycemic regulation in adults with elevated body fat percentage. The WM 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. Participants enrolled in the study will be required to undergo blood collection, height measurement, body composition analysis, and questionnaire completion. Each testing session will take approximately 5 hours, and participants will need to complete two trial visits in total. There will be a 7-day washout period between the two trial sessions (i.e., after completion of the first trial, the second trial will be scheduled at least 7 days later). On each trial day, blood samples and relevant assessments will be conducted at the following time points: before ingestion of the test product or water, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion.

Detailed description

This study is a single-center, crossover clinical trial in which each participant serves as their own control. The aim is to evaluate the effects of the WM Formula dietary supplement on promoting endogenous GLP-1 secretion and suppressing appetite in adults with elevated body fat percentage. Eligible participants will be adults aged 18 years or older, screened based on body fat percentage. Inclusion criteria: -Body fat percentage ≥30% for females or ≥25% for males. Exclusion criteria: * Prior use of GLP-1 receptor agonists approved in Taiwan (e.g., liraglutide, semaglutide, dulaglutide), * Use of blood glucose-regulating medications, * Presence of major organic diseases, Or a history of hypoglycemia. After enrollment, participants will be required to visit TCI Co., Ltd. for blood collection, height and body composition measurements, and completion of questionnaires. Each study visit will take approximately 5 hours, and participants will undergo two test sessions, separated by a 7-day washout period (i.e., after completing the first test, the second will occur at least 7 days later). On each test day, blood samples (\~14 mL per time point) will be collected via an indwelling venous catheter at the following time points: before ingestion of the test product or water, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion. The blood samples will be analyzed for GLP-1, DPP-4, complete blood count (CBC), blood glucose, and insulin concentrations.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	WM formula Group	Participants in the intervention group will consume a single dose of WM 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.
OTHER	Control group	Participants in the control group will consume 50 mL water

Timeline

• Start date: 2025-08-31
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2025-08-01
• Last updated: 2025-08-01

Locations

1 site across 1 country: Taiwan