Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Total Cholesterol
研究概览
简要总结
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-55 years old
- •Total Cholesterol 200~260 mg/dl or LDL-C 110~190 mg/dl
- •Able to give informed consent
排除标准
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •History of alcohol or substance abuse
- •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
- •Pregnant or lactating women etc.
研究组 & 干预措施
Kochujang Pills
干预措施: Kochujang Pills (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in Total Cholesterol
时间窗: 12 weeks
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)
时间窗: 12 weeks
LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
次要结局
- Changes in Triglyceride(12 weeks)
- Changes in HDL-C(High Density Lipoprotein-cholesterol)(12 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital