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临床试验/NCT06535620
NCT06535620尚未招募1 期

Comparison of the Effect of Red Wine With Alcohol on Flow-mediated Dilation Versus Red Wine Without Alcohol - a Randomized Clinical Trial

Instituto de Cardiologia de Santa Catarina0 个研究点目标入组 15 人开始时间: 2024年8月13日最近更新:
适应症

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

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

发起方
Instituto de Cardiologia de Santa Catarina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Medeiros Moreira

Professor of Cardiology

Instituto de Cardiologia de Santa Catarina

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