About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
consume alcohol sporadically
Disqualifiers
continuous medication, including anti-inflammatories
pregnant women
Trial design
Parallel
Treatments tested in this trial
red wine with alcohol
Other intervention200 ml of red wine - Demi sec Bordeaux wine 'La Dorni' (alcohol content at 20ºC of 10.1% - Alves \& Martins Bebidas Especiais LTDA - Bandeirantes, Parana - Brazil)
red wine without alcohol
Other intervention200 ml of red wine without alcohol - Demi sec Bordeaux wine 'Casa Navaronne' (alcohol content at 20ºC of 0.23% - Alves \& Martins Bebidas Especiais LTDA - Bandeirantes, Parana - Brazil)
Treatment groups
Trial outcomes
Primary outcomes
Flow-mediated dilation
Evaluate flow-mediated dilation after the consumption of red wine compared to placebo
Secondary outcomes
Heart rate
Analyze the difference in heart rate (in bpm) after the consumption of red wine compared to the consumption of non-alcoholic wine.
Blood pressure
Analyze the difference in blood pressure (in mmHg) after the consumption of red wine compared to the consumption of non-alcoholic wine.
Brachial artery diameter at rest
Evaluate the difference in the diameter (at rest) of the brachial artery (measured in millimeters) before and after consuming red wine.
Brachial artery diameter after endothelial stress
Evaluate the difference in the diameter (after endothelial stress) of the brachial artery (measured in millimeters) before and after consuming red wine.
Locations
Sponsors and contacts
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Instituto de Cardiologia de Santa Catarina
Lead sponsor
Universidade do Sul de Santa Catarina
Collaborator
This trial is not recruiting at the moment. You can still explore other options: