Comparison of the Effect of Red Wine With Alcohol on Flow-mediated Dilation Versus Red Wine Without Alcohol

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorInstituto de Cardiologia de Santa Catarina

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 volunteers

Qualifiers

consume alcohol sporadically

Disqualifiers

continuous medication, including anti-inflammatories

pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • red wine with alcohol

    Other intervention

    200 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 intervention

    200 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

15 Participants
are divided into 2 treatment groups
Group A: red wine with alcoholExperimental treatment 1 intervention
Group B: red wine without alcoholPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Flow-mediated dilation

Evaluate flow-mediated dilation after the consumption of red wine compared to placebo

Time frame
40 minutes after the substance intake

Secondary outcomes

1

Heart rate

Analyze the difference in heart rate (in bpm) after the consumption of red wine compared to the consumption of non-alcoholic wine.

Time frame
40 minutes after the substance intake
2

Blood pressure

Analyze the difference in blood pressure (in mmHg) after the consumption of red wine compared to the consumption of non-alcoholic wine.

Time frame
40 minutes after the substance intake
3

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.

Time frame
40 minutes after the substance intake
4

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.

Time frame
40 minutes after the substance intake

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: