The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ApoA-I level
研究概览
简要总结
Although much effort has been done to lower LDL-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite many initiatives, no new widely applicable intervention strategies with proven efficacy have been developed.
Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human intervention studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 45 and 70 years
- •HDL-C <1.0 mmol/L (men)
- •HDL-C <1.3 mmol/L (women)
- •serum total cholesterol <8.0 mmol/L
- •plasma glucose <7.0 mmol/L
- •BMI between 25 - 35 kg/m2
- •non-smoking
- •willingness to abstain from resveratrol rich products from two weeks prior to the study and the duration of the study:
- •grapes and grape juice
- •wine (red and white)
- •all berries
- •peanut butter
- •soy (products)
- •pomegranate
排除标准
- •unstable body weight (weight gain or loss >3 kg in the past 3 months)
- •indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- •use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism
- •Active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
- •not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
- •men: consumption of >21 glasses of alcohol-containing drinks per week women: consumption of >14 glasses of alcohol-containing drinks per week
- •abuse of drugs
- •pregnant or breastfeeding women
- •participation in another biomedical study within 1 month prior to the screening visit
- •having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
- •impossible or difficult to puncture as evidenced during the screening visits
结局指标
主要结局
ApoA-I level
时间窗: Measured at baseline, after 4 weeks, 8 weeks and 12 weeks
次要结局
- Lipid and glucose metabolism during the fasting and postprandial phase(Measured at baseline, after 4 weeks, 8 weeks and 12 weeks)
- biomarkers for low-grade systemic inflammation and endothelial function(Measured at baseline, after 4 weeks, 8 weeks and 12 weeks)
- Endothelial function of the retinal microvasculature(Measured in weeks 4 and 12)
- Endothelial function and arterial stiffness(Measured in weeks 4 and 12)