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Not yet recruiting NCT06535620

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

Phase I / Phase II Interventional Healthy Healthy Diet

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: red wine with alcohol, red wine without alcohol.
Who it may be relevant to
Registry conditions: Healthy, Healthy Diet. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Other red wine with alcohol
    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)
  • Other red wine without alcohol
    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 outcome measures

  • Flow-mediated dilation [Time frame: 40 minutes after the substance intake]
Secondary outcome measures (4)
  • Heart rate [Time frame: 40 minutes after the substance intake]
  • Blood pressure [Time frame: 40 minutes after the substance intake]
  • Brachial artery diameter at rest [Time frame: 40 minutes after the substance intake]
  • Brachial artery diameter after endothelial stress [Time frame: 40 minutes after the substance intake]

Eligibility criteria

Inclusion criteria

  • consume alcohol sporadically

Exclusion criteria

  • continuous medication, including anti-inflammatories
  • pregnant women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06535620 · 78483823.4.0000.0261

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗