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| Name | Class |
|---|---|
| Universidade do Sul de Santa Catarina | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| red wine with alcohol | Experimental | The red wine group |
|
| red wine without alcohol | Placebo Comparator | The non-alcoholic wine group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Flow-mediated dilation | Evaluate flow-mediated dilation after the consumption of red wine compared to placebo | 40 minutes after the substance intake |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Analyze the difference in heart rate (in bpm) after the consumption of red wine compared to the consumption of non-alcoholic wine. | 40 minutes after the substance intake |
| Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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) |
|
Analyze the difference in blood pressure (in mmHg) after the consumption of red wine compared to the consumption of non-alcoholic wine.
| 40 minutes after the substance intake |
| Brachial artery diameter at rest | Evaluate the difference in the diameter (at rest) of the brachial artery (measured in millimeters) before and after consuming red wine. | 40 minutes after the substance intake |
| Brachial artery diameter after endothelial stress | Evaluate the difference in the diameter (after endothelial stress) of the brachial artery (measured in millimeters) before and after consuming red wine. | 40 minutes after the substance intake |