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NCT Number: NCT06535620

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

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).

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • consume alcohol sporadically

Exclusion criteria

  • continuous medication, including anti-inflammatories
  • pregnant women

Treatment and study plan

red wine with alcohol

Other

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

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)

Primary outcomes

  1. Flow-mediated dilation

    Time frame: 40 minutes after the substance intake

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

Secondary outcomes

  1. Heart rate

    Time frame: 40 minutes after the substance intake

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

  2. Blood pressure

    Time frame: 40 minutes after the substance intake

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

  3. Brachial artery diameter at rest

    Time frame: 40 minutes after the substance intake

    Evaluate the difference in the diameter (at rest) of the brachial artery (measured in millimeters) before and after consuming red wine.

  4. Brachial artery diameter after endothelial stress

    Time frame: 40 minutes after the substance intake

    Evaluate the difference in the diameter (after endothelial stress) of the brachial artery (measured in millimeters) before and after consuming red wine.

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia de Santa Catarina

Other

Collaborators

  • Universidade do Sul de Santa Catarina

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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