Obesity
Conditions
Keywords
Probiotic, Prebiotic, Glucagon-like peptide-1 (GLP-1), Blood glucose, Insulin
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.
Interventions
DIETARY_SUPPLEMENTWM 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.
DIETARY_SUPPLEMENTPlacebo
One glass jar (50 g) of the placebo liquid drink was administered once daily, 1 hour prior to the first meal of the day.
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in weight at weeks 2 and 4 | 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 | 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 | Week 0, 2 and 4 | Assessment of blood glucose changes at weeks 0, 2, and 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from plasma DPP-4 concentration (ng/mL) in baseline at weeks 2 and 4 | Week 0, 2 and 4 | Assessment of plasma DPP-4 concentration changes at weeks 0, 2, and 4 |
| Change from plasma PAI-1 concentration (ng/mL) in baseline at weeks 2 and 4 | Week 0, 2 and 4 | Assessment of plasma PAI-1 concentration changes at weeks 0, 2, and 4 |
Countries
Taiwan
Outcome results
None listed