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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07082062
Enrollment
100
Registered
2025-07-24
Start date
2025-06-02
Completion date
2025-12-31
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

Probiotic, Prebiotic, Glucagon-like peptide-1 (GLP-1), Blood glucose, Insulin

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTGLP-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.

Sponsors

TCI Co., Ltd.
CollaboratorINDUSTRY
Shih Chien Huang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma GLP-1 concentration (pmol/L)Day 1 and Day 7Plasma 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 7Blood 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 7Serum 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.

Countries

Taiwan

Contacts

Primary ContactShih-Chien Huang, PhD, Associate Professor
schuang@csmu.edu.tw+886424730022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026