Evaluation of the Efficacy of the Composite WM Formula in Body Weight Change

This study aims to evaluate the effects of the combined formula WM Formula, used as a dietary supplement, with a focus on improvements in glycemic and lipid parameters, body composition, and gut microbiota profiles.

Study Overview

• Status: Withdrawn
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: WM formula liquid drink; Dietary supplement: Placebo

Detailed Description

This study is a single-center, randomized, double-blind, placebo-controlled human clinical trial designed to evaluate the potential effect of the WM Formula composite supplement on body weight. Eligible participants will be adults aged 18 years or older, screened based on waist circumference or body fat percentage.

Participants will be randomly assigned to one of two groups: one receiving the combined formula WM Formula, and the other receiving a placebo. Each group will take either the WM Formula or placebo, and undergo regular assessments throughout the 4-week study period. Physiological parameters (e.g., height, weight, blood pressure, BMI) and biochemical markers (including liver and kidney function, lipid profile, and blood glucose levels) will be collected at baseline (Week 0), Week 2, and Week 4. In addition, participants will complete appetite assessment questionnaires and other surveys to evaluate changes in appetite and gastrointestinal symptoms.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • TCI Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WM formula liquid drink; WM formula liquid drink, 50 g/glass jar	Dietary supplement: WM formula liquid drink; One glass jar (50 g) of the WM formula liquid drink was administered once daily, 1 hour prior to the first meal of the day.
Placebo Comparator: Placebo; The placebo contained the same base ingredients as the WM formula but without the active WM formula component.	Dietary supplement: Placebo; One glass jar (50 g) of the placebo liquid drink was administered once daily, 1 hour prior to the first meal of the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in weight at weeks 2 and 4	Assessment of changes in weight at baseline, week 2, and week 4	Week 0, 2 and 4
Change from plasma GLP-1 concentration (pmol/L) in baseline at weeks 2 and 4		Assessment of changes in GLP-1 concentration at baseline, week 2, and week 4
Change from baseline in blood glucose at weeks 2 and 4	Assessment of blood glucose changes at weeks 0, 2, and 4	Week 0, 2 and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from plasma DPP-4 concentration (ng/mL) in baseline at weeks 2 and 4	Assessment of plasma DPP-4 concentration changes at weeks 0, 2, and 4	Week 0, 2 and 4
Change from plasma PAI-1 concentration (ng/mL) in baseline at weeks 2 and 4	Assessment of plasma PAI-1 concentration changes at weeks 0, 2, and 4	Week 0, 2 and 4

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: July 30, 2025
• First Posted (Actual): August 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Insulin; Prebiotic; Probiotic; Blood glucose; Glucagon-like peptide-1 (GLP-1)
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Insulin Resistance
• Other Study ID Numbers: 25-047-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No