Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination in Moderately Hypercholesterolemic Subjects in Primary Prevention for Cardiovascular Diseases: a Randomized, Double Blind, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- LDL cholesterolemia reduction from baseline and between groups
研究概览
简要总结
A large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.
详细描述
A large body of literature suggest that the patients are strongly interested in self-medicating them with "natural" products aimed at reducing their plasma level of LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product with these properties in Western countries. However plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. In this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of LDL-reduction in humans.
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
- Double (Participant, 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
- 是
入选标准
- •LDL-cholesterolemia between 130 and 190 mg/dL
排除标准
- •Type 2 diabetes
- •Previous cardiovascular disease
- •Assumption of lipid-lowering drugs or dietary supplements
- •Previous intolerance to red yeast rice
结局指标
主要结局
LDL cholesterolemia reduction from baseline and between groups
时间窗: 8 weeks
Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment
次要结局
- Non-HDL cholesterolemia reduction from baseline and between groups(8 weeks)
- Number of Participants With Treatment-Related Adverse Events(8 weeks)
研究者
Claudio Borghi
Full professor of internal medicine
University of Bologna