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Completed

NCT Number: NCT07097987

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TCI Co., Ltd.

Taipei, Taiwan

About this study

This study is a double-blind, single-center, crossover clinical trial in which each participant serves as their own control. The aim is to evaluate the effects of the WM Formula dietary supplement on promoting endogenous GLP-1 secretion and suppressing appetite in adults with elevated body fat percentage.

Eligible participants will be adults aged between 18 and 65 years, screened based on body fat percentage and BMI.

Inclusion criteria

  • Body fat percentage 30-45% for females or 25-40% for males.
  • BMI 23-34 kg/m2

Exclusion criteria

  • Prior use of GLP-1 receptor agonists approved in Taiwan (e.g., liraglutide, semaglutide, dulaglutide),
  • Use of blood glucose-regulating medications,
  • Presence of major organic diseases, Or a history of hypoglycemia.

After enrollment, participants will be required to visit TCI Co., Ltd. for blood collection, height and body composition measurements, and completion of questionnaires. Each study visit will take approximately 5 hours, and participants will undergo two test sessions, separated by a 7-day washout period (i.e., after completing the first test, the second will occur at least 7 days later).

On each test day, blood samples (~14 mL per time point) will be collected via an indwelling venous catheter 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. The blood samples will be analyzed for GLP-1, DPP-4, complete blood count (CBC), blood glucose, and insulin concentrations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Bifidobacterium breve, Rocket Apple extract, kombucha, soy peptide powder, arabic gum (gum acacia), erythritol

Control Group

Other

Participants in the control group will consume 50 mL water

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 WM 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 WM 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 WM Formula on Days 1 and 7.

  4. Plasma DPP-4 concentration (ng/mL)

    Time frame: Day 1 and Day 7

    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.

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
May 13, 2026

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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