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

I

Instituto de Cardiologia de Santa Catarina

Status and phase

Not yet enrolling
Phase 2
Phase 1

Conditions

Healthy
Healthy Diet

Treatments

Other: red wine with alcohol
Other: red wine without alcohol

Study type

Interventional

Funder types

Other

Identifiers

NCT06535620
78483823.4.0000.0261

Details and patient eligibility

About

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).

Enrollment

15 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • consume alcohol sporadically

Exclusion criteria

  • continuous medication, including anti-inflammatories
  • pregnant women

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups, including a placebo group

red wine with alcohol
Experimental group
Description:
The red wine group
Treatment:
Other: red wine with alcohol
red wine without alcohol
Placebo Comparator group
Description:
The non-alcoholic wine group
Treatment:
Other: red wine without alcohol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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