NCT06628791已完成不适用
Effects of Oral Intake of BK329 on Body Fat Reduction in Adults With Overweight or Obesity: a Randomized, Double-blind, Placebo-controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total body fat (kg)
研究概览
简要总结
This clinical trial aims to determine whether BK329 reduces body fat in adults with overweight or obesity and to assess its safety.
The main questions are:
- Does BK329 reduce body fat in participants?
- What side effects occur when participants take BK329?
详细描述
Researchers will compare BK329 to a placebo to evaluate its effectiveness in reducing body fat.
Participants will:
- Take BK329 or a placebo daily for 12 weeks.
- Visit the clinic every six weeks for checkups and tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals with a Body Mass Index (BMI) between 23 and 30 kg/m
- •Individuals who have provided written consent on the consent form.
排除标准
- •Subjects with severe cerebrovascular disease (e.g., stroke, cerebral hemorrhage), heart disease (e.g., angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumors within the last 6 months. (However, subjects with a history of these diseases who are clinically stable may participate at the investigator's discretion.)
- •Uncontrolled hypertensive patients (blood pressure ≥160/100mmHg, measured after 10 minutes of rest).
- •Diabetic patients with poor blood glucose control (fasting glucose ≥160mg/dL).
- •Subjects undergoing treatment for hypothyroidism or hyperthyroidism.
- •Subjects with creatinine levels ≥ 2 times the upper limit of the research institution's normal range.
- •Subjects with aspartate transaminase or alanine transaminase levels ≥ 3 times the upper limit of the research institution's normal range.
- •Subjects experiencing severe gastrointestinal symptoms such as heartburn or indigestion (lactose intolerance).
- •Subjects who have taken weight-altering drugs (absorption inhibitors, appetite suppressants, obesity-related supplements, psychiatric drugs, beta-blockers, diuretics, contraceptives, steroids, or female hormones) within the last month.
- •Subjects who have participated in commercial weight loss programs within the last 3 months.
- •Subjects who have participated in or plan to participate in another clinical trial within the last month.
- •Alcohol abusers.
- •Subjects who quit smoking within the last 3 months.
- •Pregnant or breastfeeding women or those planning pregnancy during the trial period.
- •Subjects with allergies to any components of the study foods.
- •Subjects deemed inappropriate for the study by the investigator for other reasons.
研究组 & 干预措施
BK329 group
Experimental
This group takes BK329 for 12 weeks.
干预措施: BK329 (Dietary Supplement)
Placebo group
Placebo Comparator
This group takes placebo for 12 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Total body fat (kg)
时间窗: 12 weeks
Using dual-energy X-ray absorptiometry at baseline and 12 weeks
次要结局
- Body fat percentage(12 weeks)
- Lean body mass (kg)(12 weeks)
- Body mass index (kg/m2)(12 weeks)
- Body weight (kg)(12 weeks)
- Waist-to-hip ratio(12 weeks)
- Total cholesterol level (mg/dl)(12 weeks)
- Triglycerides level (mg/dL)(12 weeks)
- High-density lipoprotein cholesterol levels (mg/dL)(12 weeks)
- Low-density lipoprotein cholesterol levels (mg/dL)(12 weeks)
- Free fatty acid level (mg/dL)(12 weeks)
- High-sensitivity C-reactive protein (mg/dL)(12 weeks)
- Total immunoglobulin E level (IU/mL)(12 weeks)
- Neutrophil-to-lymphocyte ratio(12 weeks)
研究者
Sang Yeoup Lee
Professor, MD, PhD
Pusan National University Yangsan Hospital
研究点 (1)
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