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

NCT06535620 | Not Yet Recruiting Phase 1

• 1 other identifier: 78483823.4.0000.0261
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

wine; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Flow-mediated dilation

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

  40 minutes after the substance intake

Secondary Outcomes (4)

• Heart rate

  40 minutes after the substance intake

• Blood pressure

  40 minutes after the substance intake

• Brachial artery diameter at rest

  40 minutes after the substance intake

• Brachial artery diameter after endothelial stress

  40 minutes after the substance intake

Study Arms (2)

red wine with alcohol

EXPERIMENTAL

The red wine group

Other: red wine with alcohol

red wine without alcohol

PLACEBO COMPARATOR

The non-alcoholic wine group

Other: red wine without alcohol

Interventions

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 with alcohol

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)

red wine without alcohol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• consume alcohol sporadically

You may not qualify if:

• continuous medication, including anti-inflammatories
• pregnant women

Sponsors & Collaborators

• Instituto de Cardiologia de Santa Catarina: lead
• Universidade do Sul de Santa Catarina: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 2, 2024
• Study Start: August 13, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 15, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share