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

NCT06535620 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-08-16

No results posted yet for this study

Summary

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).

Conditions

  • Healthy
  • Healthy Diet

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)

Sponsors & Collaborators

  • Universidade do Sul de Santa Catarina

    collaborator OTHER_GOV

  • Instituto de Cardiologia de Santa Catarina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2024-10-30
Completion
2024-11-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535620 on ClinicalTrials.gov