Evaluation of the Efficacy of the Composite WM Formula in Body Weight Change
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- TCI Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from baseline in weight at weeks 2 and 4
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
WM formula liquid drink
WM formula liquid drink, 50 g/glass jar
Intervention: WM formula liquid drink (Dietary Supplement)
Placebo
The placebo contained the same base ingredients as the WM formula but without the active WM formula component.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change from baseline in weight at weeks 2 and 4
Time Frame: Week 0, 2 and 4
Assessment of changes in weight at baseline, week 2, and week 4
Change from plasma GLP-1 concentration (pmol/L) in baseline at weeks 2 and 4
Time Frame: Assessment of changes in GLP-1 concentration at baseline, week 2, and week 4
Change from baseline in weight at weeks 2 and 4
Time Frame: Week 0, 2 and 4
Assessment of changes in weight at baseline, week 2, and week 4
Change from plasma GLP-1 concentration (pmol/L) in baseline at weeks 2 and 4
Time Frame: 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
Time Frame: Week 0, 2 and 4
Assessment of blood glucose changes at weeks 0, 2, and 4
Secondary Outcomes
- 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)