Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07082062

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight

Full registry criteria

Inclusion Criteria: * Male or female participants aged 18-50 years with a body fat percentage greater than 25%. Exclusion Criteria: * 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.

Treatments and study arms

GLP-1 formula Group

Dietary Supplement

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 outcomes

Plasma GLP-1 concentration (pmol/L)Day 1 and Day 7

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.

Blood glucose concentration (mg/dL)Day 1 and Day 7

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.

Serum insulin concentration (μIU/mL)Day 1 and Day 7

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.

Study locations

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Chung Shan Medical University Hospital🇹🇼 Taichung, Taiwan

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Shih-Chien Huang, PhD, Associate ProfessorContact

Email · Call +886424730022