Randomized Clinical Trial to Evaluate the Middle Term Effect of a Dietary Supplement Containing Red Yeast Rice (Total Monacolin <3 mg/Dose) or Placebo on Plasma Lipids and Proteoma in Subjects With Suboptimal Cholesterolemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment-dependent change in LDL-C
研究概览
简要总结
The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged ≥ 30 years and ≤ 70 years old.
- •Body Mass Index included between 18 Kg/m2 and 35 Kg/m2
- •Total cholesterolemia between 200 and 280 mg/dL and/or LDL-Cholesterol between 130 mg/dL and 190 mg/dL.
- •TG<400 mg/dL.
- •Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
- •Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- •Subjects agree to participate in the study and having dated and signed the informed consent form.
排除标准
- •Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism;
- •Assumption of any kind of drug treatment non-stabilized for at least 3 months;
- •Known current thyroid, gastrointestinal or hepatobiliary diseases (including liver transaminases ≥3ULN), as well as any muscular disorders (even subclinical, including serum CPK ≥3ULN);
- •Current or previous alcohol abuse;
- •Pregnancy and Breastfeeding
- •Known previous intolerance to red yeast rice
- •History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
- •Any medical or surgical condition that would limit the patient adhesion to the study protocol.
结局指标
主要结局
Treatment-dependent change in LDL-C
时间窗: 6 weeks
The primary objective is to evaluate the effect of the tested dietary supplement containing less than 3 mg of total monacolins per daily dose on LDL cholesterol level versus placebo after 6 weeks of treatment vs placebo in healthy subjects with suboptimal cholesterolemia
次要结局
- Treatment-dependent change in plasma proteomic pattern(6 weeks)
- Treatment-dependent change in liver parameters(6 weeks)
- Treatment-dependent change in CPK plasma levels(6 weeks)
- Treatment-dependent change in Total Cholesterol(6 weeks)
- Treatment-dependent change in Non-HDL-C(6 weeks)
研究者
Arrigo F.G. Cicero
Prof. Dr.
University of Bologna