NCT02492464已完成不适用
Double-blind, Randomized Clinical Trial on the Middle-term Effect of the Red Yeast Rice Intake on Endothelial Function and Arterial Stiffness in Subjects With Suboptimal LDL-cholesterol Level in the Context of the Mediterranean Diet
University of Bologna2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Flow mediated dilation (FMD) change from the baseline to the end of treatment period
研究概览
简要总结
This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL-cholesterol between 130 and 190 mg/dL
排除标准
- •Secundary prevention for cardiovascular disease
- •Type 2 diabetes
- •Assumption of lipid-lowering drug or dietary supplements
- •Previous intolerans to read yeast rice including dietary supplements
结局指标
主要结局
Flow mediated dilation (FMD) change from the baseline to the end of treatment period
时间窗: 6 months
次要结局
- 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period(6 months)
研究者
Claudio Borghi
Professor Claudio Borghi
University of Bologna
研究点 (2)
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