Randomised Clinical Trial to Assess the Medium-term Effect of 30 g/Day of a Vitaminised Corn Oil or Olive Oil, on Lipid Parameters, Vascular Risk Markers Blood Pressure and Endothelial Function, in Moderately Hypercholesterolemic Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period
研究概览
简要总结
This will be a randomized clinical trial carried out on subjects with suboptimal control of cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9
详细描述
In order to assess the mid term effects of vitaminized corn oil on endothelial function and on early markers of functional damage of the arterial wall, moderately hypercholesterolemic subjects will be supplemented for 8 weeks with 30 g/day of both a vitaminized corn oil (plus B6 and E vitamins) or olive oil. The two intervention periods will be spaced by a 4 week washout period.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total cholesterol between 200 and 280 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL
- •Triglycerides lower than 200 mg/dL
- •Cardiovascular risk at 10 years lower than 10%
- •Informed consent
排除标准
- •Secundary prevention for cardiovascular diseases
- •BMI higher than 30
- •Assumption of lipid lowering drug or supplement
- •Alcohol abuse
- •Alterations in thyroid, liver or kidney functions, muscle diseases
结局指标
主要结局
Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period
时间窗: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
12 hour fasting lipid profile change from the baseline to the end of the intervention period
时间窗: At the first visit (run-in) at the beginning, after 4 and 8 weeks of both intervention periods (up to 24 weeks)
PCSK9 levels change from the baseline to the end of the intervention period
时间窗: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
次要结局
- Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period(At the beginning and after 8 weeks of both intervention periods (up to 24 weeks))
- Blood pressure change from the baseline to the end of the intervention period(6 months)
- Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period(At the beginning and after 8 weeks of both intervention periods (up to 24 weeks))
研究者
Claudio Borghi
Chief Internal Medicine Unit
University of Bologna