Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- LDL-cholesterolemia absolute 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 red yeast rice, phytosterols and L-tyrosol. 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
European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol.
In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity.
Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids.
No data are available on the combined effects of these dietary supplement 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
- •Suboptimal LDL level (115-160 mg/dL)
- •TG<400 mg/dL
- •Signed informed consent form
排除标准
- •Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 10 years
- •LDL-C<115 mg/dL or >160 mg/dL, TG>400 mg/dL
- •Obesity (BMI>30 kg/m2) or diabetes mellitus
- •Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism
- •Antihypertensive treatment not stabilized since at least 3 months
- •Known current thyroid, gastrointestinal or liver diseases
- •Any medical or surgical condition that would limit the patient adhesion to the study protocol
结局指标
主要结局
LDL-cholesterolemia absolute reduction from baseline and between groups
时间窗: 8 weeks
Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment
LDL-cholesterolemia % reduction from baseline and between groups
时间窗: 8 weeks
% reduction of LDL-cholesterolemia after 8 weeks of treatment
次要结局
- Flow-mediated dilation improvement from baseline and between groups(8 weeks)
研究者
Claudio Borghi
Principal Investigator, Professor Claudio Borghi
University of Bologna