Evaluation of the Efficacy of the Composite WM Formula in Promoting GLP-1 Secretion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasma GLP-1 concentration (pmol/L)
研究概览
简要总结
The goal of this clinical trial is to evaluate the physiological effects of a WM Formula on glucagon-like peptide-1 (GLP-1) secretion and glycemic regulation in adults with elevated body fat percentage. The WM Formula is a multi-component dietary supplement composed of Bifidobacterium breve (Active), Rocket Apple Extract Powder (Active), Probio-kombu Black Tea Powder (Active), Soy Protein (Excipient), Gum Acacia (Excipient), and Erythritol (Excipient).
Participants enrolled in the study will be required to undergo blood collection, height measurement, body composition analysis, and questionnaire completion. Each testing session will take approximately 5 hours, and participants will need to complete two trial visits in total. There will be a 7-day washout period between the two trial sessions (i.e., after completion of the first trial, the second trial will be scheduled at least 7 days later). On each trial day, blood samples and relevant assessments will be conducted at the following time points: before ingestion of the test product or placebo, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion.
详细描述
This study is a double-blind, single-center, crossover clinical trial in which each participant serves as their own control. The aim is to evaluate the effects of the WM Formula dietary supplement on promoting endogenous GLP-1 secretion and suppressing appetite in adults with elevated body fat percentage.
Eligible participants will be adults aged between 18 and 65 years, screened based on body fat percentage and BMI.
Inclusion criteria:
- Body fat percentage 30-45% for females or 25-40% for males.
- BMI 23-34 kg/m2
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（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%-45% for females and 25%-40% for males, and BMI 23 - 34 kg/m
- •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
Experimental: WM formula Group
Participants in the intervention group will consume a single dose of WM formula sachet (800 mg) on the study day. The formula includes Bifidobacterium breve (Active), Rocket Apple Extract Powder (Active), Probio-Kombu Black Tea Powder (Active), Soy Protein (Excipient), Gum Acacia (Excipient), and Erythritol (Excipient).
干预措施: WM formula Group (Dietary Supplement)
No Intervention: Control group
Participants in the control group will consume 800 mg/sachet
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Plasma GLP-1 concentration (pmol/L)
时间窗: Day 1 and Day 7
Plasma GLP-1 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Blood glucose concentration (mg/dL)
时间窗: Day 1 and Day 7
Blood glucose levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Serum insulin concentration (μIU/mL)
时间窗: Day 1 and Day 7
Serum insulin levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Plasma DPP-4 concentration (ng/mL)
时间窗: Day 1 and Day 7
Plasma DPP-4 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Plasma GLP-1 concentration (pmol/L)
时间窗: Day 1 and Day 7
Plasma GLP-1 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Blood glucose concentration (mg/dL)
时间窗: Day 1 and Day 7
Blood glucose levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Plasma DPP-4 concentration (ng/mL)
时间窗: Day 1 and Day 7
Plasma DPP-4 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Serum insulin concentration (μIU/mL)
时间窗: Day 1 and Day 7
Serum insulin levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
次要结局
未报告次要终点