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

TCI

Status: Not yet enrolling

Conditions: Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: WM formula liquid drink

Study type: Interventional

Funder types: Industry

Identifiers

NCT07097974

25-047-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

WM formula liquid drink

Experimental group

Description:

WM formula liquid drink, 50 g/glass jar

Treatment:

Dietary Supplement: WM formula liquid drink

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo