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

NCT07097974 | Withdrawn

• 1 other identifier: 25-047-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change from plasma DPP-4 concentration (ng/mL) in baseline at weeks 2 and 4

  Week 0, 2 and 4

• Change from plasma PAI-1 concentration (ng/mL) in baseline at weeks 2 and 4

  Week 0, 2 and 4

Study Arms (2)

WM formula liquid drink

EXPERIMENTAL

WM formula liquid drink, 50 g/glass jar

Dietary Supplement: WM formula liquid drink

Placebo

PLACEBO COMPARATOR

The placebo contained the same base ingredients as the WM formula but without the active WM formula component.

Dietary Supplement: Placebo

Interventions

WM formula liquid drink DIETARY_SUPPLEMENT

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.

WM formula liquid drink

Placebo DIETARY_SUPPLEMENT

One glass jar (50 g) of the placebo liquid drink was administered once daily, 1 hour prior to the first meal of the day.

Placebo

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

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2026-05

Locations

TW (1)