Evaluation of the Efficacy of the Composite WM Formula in Body Weight Change
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in weight at weeks 2 and 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
WM formula liquid drink
WM formula liquid drink, 50 g/glass jar
干预措施: 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.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from baseline in weight at weeks 2 and 4
时间窗: 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
时间窗: Assessment of changes in GLP-1 concentration at baseline, week 2, and week 4
Change from baseline in weight at weeks 2 and 4
时间窗: 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
时间窗: 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
时间窗: Week 0, 2 and 4
Assessment of blood glucose changes at weeks 0, 2, and 4
次要结局
- 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)