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

Randomized clinical trial evaluating the effect on many molecular markers well established as atherosclerosis/cardiovascular risk factors of moderate different alcoholic beverages consumption on healthy subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15978506
Enrollment
40
Registered
2019-11-01
Start date
2019-11-01
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Atherosclerosis Circulatory System

Interventions

This is a crossover study. Participants will be randomized using computer software to determine whether they consume red wine or cachaça in the first intervention period. Each participant will start

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
C-reactive Protein (CRP) level in blood at days 7, 35, 42 and 70

Secondary

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

Countries

Brazil

Contacts

Public ContactPedro Cellia
pedrohenriquemcellia@gmail.com+5511942324656

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026