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

Phase 1

Not yet recruiting

• Conditions: Healthy; Healthy Diet
• Interventions: Other: red wine without alcohol; Other: red wine with alcohol

• Registration Number: NCT06535620
• Lead Sponsor: Instituto de Cardiologia de Santa Catarina

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-30
• Status Verified: 2024-08
• Study First Posted: 2024-08-02
• Study Start: 2024-08-13
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-16
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• consume alcohol sporadically

Exclusion Criteria

• continuous medication, including anti-inflammatories
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
red wine without alcohol	red wine without alcohol	The non-alcoholic wine group
red wine with alcohol	red wine with alcohol	The red wine group

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilation	40 minutes after the substance intake	Evaluate flow-mediated dilation after the consumption of red wine compared to placebo

Secondary Outcome Measures

Name	Time	Method
Blood pressure	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.
Heart rate	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.
Brachial artery diameter at rest	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.
Brachial artery diameter after endothelial stress	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.