A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Changes of Total cholesterol
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol.
详细描述
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into unripe Bokbunja extract 600 mg or placebo group. The investigators measured total cholesterol, lipid profile, arteriosclerosis index, anthropometric index, oxidized LDL.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 20 and 65 years,
- •Total cholesterol 200-239 mg/dl
- •subjects giving written informed consent
排除标准
- •Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction
- •History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnancy or breast feeding etc,.
研究组 & 干预措施
unripe Bokbunja Extract
tablet(1 tablet/d, 600 mg/d) for 12 weeks
干预措施: unripe Bokbunja Extract (Dietary Supplement)
unripe Bokbunja Extract
tablet(1 tablet/d, 600 mg/d) for 12 weeks
干预措施: Placebo (Dietary Supplement)
Placebo
Placebo for 12 weeks
干预措施: unripe Bokbunja Extract (Dietary Supplement)
Placebo
Placebo for 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes of Total cholesterol
时间窗: 12 weeks
Changes of total cholesterol were assessed before and after the intervention
次要结局
- Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)(12 weeks)
- Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)(12 weeks)
- Changes of Arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1)(12 weeks)
- Changes of Oxidized LDL(12 weeks)
研究者
Jong Ho Lee
Professor, Principal Investigator
Yonsei University