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NCT Number: NCT07082062

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.

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Key information

Conditions

Overweight Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location status: Recruiting

Location contact

Shih-Chien Huang, PhD, Associate Professor

CONTACT

[email protected]

+886424730022

About this study

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 (a probiotic strain), ClpB Formula (a prebiotic mixture composed of kombucha extract, soy peptide powder, L-arabinose, and erythritol), and rocket apple extract, which together are hypothesized to act synergistically to promote endogenous GLP-1 secretion and improve postprandial glucose control.

The study consists of two randomized crossover trials. Trial 1 aims to evaluate the acute effects of the formula on plasma GLP-1 concentrations following a single oral dose. Trial 2 investigates the impact of the formula on postprandial glucose and insulin responses under similar controlled conditions. Participants will undergo two intervention visits in each trial, with a washout period between them. Each visit will last approximately six hours, during which fasting and postprandial blood samples will be collected. In addition to biochemical endpoints, appetite-related indices will also be assessed to explore the formula's potential effect on satiety.

This investigation aims to provide foundational clinical evidence regarding the efficacy of functional dietary components in modulating incretin response and glycemic homeostasis, which may inform future development of non-pharmacological strategies for metabolic regulation in populations with elevated adiposity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Bifidobacterium breve, ClpB formula consists of kombucha, soy peptide powder, L-arabinose and erythritol., Rocket Apple extract

Primary outcomes

  1. Plasma GLP-1 concentration (pmol/L)

    Time frame: 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.

  2. Blood glucose concentration (mg/dL)

    Time frame: 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.

  3. Serum insulin concentration (μIU/mL)

    Time frame: 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 contacts

Contact information is provided by the study sponsor or research team.

Shih-Chien Huang, PhD, Associate Professor

CONTACT

[email protected]

+886424730022

Sponsors and collaborators

Lead sponsor

Shih Chien Huang

Other

Collaborators

  • TCI Co., Ltd.

Registry information

Official study title

Exploring the Effects of GLP-1 Formula on GLP-1 Secretion and Postprandial Glucose Regulation

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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