Comparison of the Effect of Red Wine With Alcohol on Flow-mediated Dilation Versus Red Wine Without Alcohol - a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Flow-mediated dilation
研究概览
简要总结
Introduction: Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite being preventable. Moderate wine consumption has been associated with one of the preventative approaches due to its benefits on cardiovascular health, including endothelial protection and antioxidant effects, attributed to its chemical composition, such as flavonoids.
Objective: To assess endothelial function through flow-mediated dilation after the consumption of red wine compared to non-alcoholic wine.
Methodology: A parallel, randomized, placebo-controlled clinical trial with a blinded evaluator will be conducted with 20 healthy participants, evaluated at two distinct time points. Participants will be selected to receive either red wine or non-alcoholic wine and will be crossed over after 7 days to receive the opposite beverage from the initial one. The primary outcome will be the change in flow-mediated dilation of the brachial artery pre- and post-intervention in both groups. The secondary outcomes will include the flow-mediated dilation values, brachial artery diameter after the intervention, and measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •consume alcohol sporadically
排除标准
- •continuous medication, including anti-inflammatories
- •pregnant women
结局指标
主要结局
Flow-mediated dilation
时间窗: 40 minutes after the substance intake
Evaluate flow-mediated dilation after the consumption of red wine compared to placebo
次要结局
- Blood pressure(40 minutes after the substance intake)
- Heart rate(40 minutes after the substance intake)
- Brachial artery diameter at rest(40 minutes after the substance intake)
- Brachial artery diameter after endothelial stress(40 minutes after the substance intake)
研究者
Daniel Medeiros Moreira
Professor of Cardiology
Instituto de Cardiologia de Santa Catarina
