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

NCT ID: NCT07082062

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

Participants in the control group will consume 100 mL water

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

GLP-1 formula Group

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TCI Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Shih Chien Huang

OTHER

Sponsor Role lead

Responsible Party

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Shih Chien Huang

PhD, Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shih-Chien Huang, PhD, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shih-Chien Huang, PhD, Associate Professor

Role: CONTACT

+886424730022

Facility Contacts

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Shih-Chien Huang, PhD, Associate Professor

Role: primary

+886424730022

Other Identifiers

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CS2-24173

Identifier Type: -

Identifier Source: org_study_id

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