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

NCT07097987 | Completed

• 1 other identifier: 25-048-A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 (Active), Rocket Apple Extract Powder (Active), Probio-kombu Black Tea Powder (Active), Soy Protein (Excipient), Gum Acacia (Excipient), and Erythritol (Excipient). 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 placebo, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Plasma GLP-1 concentration (pmol/L)

  Plasma GLP-1 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.

  Day 1 and Day 7

• Blood glucose concentration (mg/dL)

  Blood glucose levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.

  Day 1 and Day 7

• Serum insulin concentration (μIU/mL)

  Serum insulin levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.

  Day 1 and Day 7

• Plasma DPP-4 concentration (ng/mL)

  Plasma DPP-4 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.

  Day 1 and Day 7

Study Arms (2)

No Intervention: Control group

PLACEBO COMPARATOR

Participants in the control group will consume 50 mL water

Other: Control group

Experimental: WM formula Group

ACTIVE COMPARATOR

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.

Dietary Supplement: WM formula Group

Interventions

WM formula Group DIETARY_SUPPLEMENT

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, arabic gum (gum acacia) and erythritol.

Also known as: Bifidobacterium breve, Rocket Apple extract, kombucha, soy peptide powder, arabic gum (gum acacia), erythritol

Experimental: WM formula Group

Control group OTHER

Participants in the control group will consume 50 mL water

No Intervention: Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older who are willing to sign the informed consent form.
• Body fat percentage: ≥30% for females and ≥25% for males.
• Non-pregnant and non-lactating women who agree to use physical contraceptive methods (e.g., condoms, intrauterine devices) throughout the study period.

You may not qualify if:

• Use of GLP-1 receptor agonists approved in Taiwan (e.g., liraglutide, semaglutide, dulaglutide), blood glucose-regulating medications, weight loss-related drugs or functional foods, probiotics, or gastrointestinal health-related supplements or medications within 30 days prior to the start of the study.
• History of chronic gastrointestinal disorders, seizure disorders or epilepsy, hepatic or renal diseases, malignancies, endocrine disorders, psychiatric illnesses, alcohol or drug abuse, or other major organic diseases based on medical history.
• History of gastrointestinal surgery, organ transplantation, or other major surgeries.
• History of hypoglycemia.
• Known lactose intolerance.
• Chronic diarrhea.
• Acute gastroenteritis within 2 weeks prior to study initiation.
• Known allergy to any ingredient in the investigational product.
• Employees or immediate family members of TCI Co., Ltd.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

TCI Co., Ltd.

Taipei, Taiwan

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Kombucha Tea; Gum Arabic; Erythritol; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tea; Plant Preparations; Biological Products; Complex Mixtures; Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Food and Beverages; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Sugar Alcohols; Alcohols; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 1, 2025
• Study Start: April 15, 2026
• Primary Completion: April 24, 2026
• Study Completion: April 24, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

TW (1)