Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava Extract in Hypercholesterolemic Korean Subjects: a Randomized Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 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 Ecklonia cava extract on hyperlipidemia.
详细描述
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia. The investigators measured improvement of lipid profile, including total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild hypercholesterolemic subjects(≥200mg/dL of total cholesterol or ≥110mg/dL of LDL-cholesterol)
排除标准
- •Self-reported pregnancy, lactation
- •Prevalent heart disease, cancer, renal disorder, or diabetes mellitus, and use of lipid-lowering drugs
研究组 & 干预措施
ECG (Ecklonia cava extract)
ECE 200mg, twice a day
干预措施: ECE (Ecklonia cava extract) (Dietary Supplement)
Placebo
Placebo 200mg, twice a day
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in total cholesterol
时间窗: 12 weeks
Changes in LDL-cholesterol
时间窗: 12 weeks
次要结局
- Changes in triglyceride(12 weeks)
- Changes in HDL-cholesterol(12 weeks)
- Changes in waist to hip ratio(12 weeks)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Food
Chonbuk National University Hospital