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

NCT ID: NCT07097974

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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WM formula liquid drink

WM formula liquid drink, 50 g/glass jar

Group Type EXPERIMENTAL

WM formula liquid drink

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TCI Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TCI Co., Ltd.

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Tong-Lin Wu

Role: CONTACT

+886 975-581-188

Facility Contacts

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Tong-Lin Wu

Role: primary

+886 975-581-188

Other Identifiers

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25-047-A

Identifier Type: -

Identifier Source: org_study_id

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