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

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

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06535620
Enrollment
15
Registered
2024-08-02
Start date
2024-08-13
Completion date
2024-11-15
Last updated
2024-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Healthy Diet

Keywords

wine, cardiovascular disease

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).

Interventions

OTHERred 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)

OTHERred 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

Universidade do Sul de Santa Catarina
CollaboratorOTHER_GOV
Instituto de Cardiologia de Santa Catarina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* consume alcohol sporadically

Exclusion criteria

* continuous medication, including anti-inflammatories * pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Flow-mediated dilation40 minutes after the substance intakeEvaluate flow-mediated dilation after the consumption of red wine compared to placebo

Secondary

MeasureTime frameDescription
Heart rate40 minutes after the substance intakeAnalyze the difference in heart rate (in bpm) after the consumption of red wine compared to the consumption of non-alcoholic wine.
Blood pressure40 minutes after the substance intakeAnalyze the difference in blood pressure (in mmHg) after the consumption of red wine compared to the consumption of non-alcoholic wine.
Brachial artery diameter at rest40 minutes after the substance intakeEvaluate 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 stress40 minutes after the substance intakeEvaluate the difference in the diameter (after endothelial stress) of the brachial artery (measured in millimeters) before and after consuming red wine.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026