NCT00938249已完成不适用
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Fasting triglyceride level
研究概览
简要总结
The purpose of the study is to determine the effect of monascus garlic fermented extract on serum lipid concentrations in subjects with moderately elevated serum triglyceride.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as based on medical history and physical examination
- •Fasting serum triglyceride 120 to 200mg/dl
- •Willing not to serve as blood donor during the study
- •Informed consent signed
排除标准
- •Female subjects who are pregnant or nursing a child
- •Participation in any clinical trial up to 90 days before Day 1 of this study
- •Renal or hepatic dysfunction
- •Heart disease
- •Under medication
- •Subjects who are taking functional food designed for weight loss or serum lipid reduction
结局指标
主要结局
Fasting triglyceride level
时间窗: Every 4 weeks (Overall 20 weeks)
次要结局
- Abdominal circumference(Every 4 weeks (Overall 20 weeks))
- Visceral fat area by CT scan(Week 0 and Week 12)
- Serum total cholesterol and LDL cholesterol levels(Every 4 weeks (Overall 20 weeks))
- Serum adiponectin level(Week 0 and Week 12)
研究者
研究点 (2)
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