Comparing the effect of moderate daily consumption of cachaça and red wine on markers of heart disease in healthy volunteers

Not Applicable

Completed

• Conditions: Atherosclerosis; Circulatory System

• Registration Number: ISRCTN15978506
• Lead Sponsor: Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Brief Summary

2022 Results article in https://doi.org/10.1016/j.clnesp.2022.10.014 (added 05/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-01
• Study Completion: 2020-11-18
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Aged over 18 years
2. Able to drink alcohol
3. Able to abstain from alcohol for 1 week

Exclusion Criteria

1. Established cardiovascular disease, defined as documented atherosclerosis, previous cardiovascular event, myocardial revascularization, heart failure
2. Chronic use of corticosteroids, non-anti-inflammatory steroidal drugs (NSAIDs), statins, oral hypoglycemic agents, insulins, anticoagulants or antiplatelet agents
3. Inability to sign the free and informed consent form
4. History of alcoholism or inability to remain abstinent for the period established in the study
5. Refusal to drink alcohol for the period established
6. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
C-reactive Protein (CRP) level in blood at days 7, 35, 42 and 70

Secondary Outcome Measures

Name	Time	Method
<br> 1. Ultrasensitive Troponin level in blood at days 7, 35, 42 and 70<br> 2. Interleukin 10 (IL-10) level in blood at days 7, 35, 42 and 70<br> 3. Interleukin 6 (IL-6) level in blood at days 7, 35, 42 and 70<br> 4. Apolipoprotein A1 (ApoA1) level in blood at days 7, 35, 42 and 70<br> 5. Apolipoprotein B (ApoB) level in blood at days 7, 35, 42 and 70<br> 6. Fasting glucose level in blood at days 7, 35, 42 and 70<br> 7. Insulin level in blood at days 7, 35, 42 and 70<br> 8. Fibrinogen level in blood at days 7, 35, 42 and 70<br> 9. Total cholesterol and fractions levels in blood at days 7, 35, 42 and 70<br> 10. Platelet aggregability test level using blood taken at days 7, 35, 42 and 70<br>