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

ISRCTN ISRCTN15978506
DOI https://doi.org/10.1186/ISRCTN15978506
Secondary identifying numbers 16758719.6.0000.0068
Submission date
11/10/2019
Registration date
01/11/2019
Last edited
05/12/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Cardiovascular (heart and blood vessel) disease remains the most common cause of death worldwide. Coronary atherosclerosis is when the blood vessels around the heart become blocked and stiffened. This is a major cause of cardiovascular disease. Drinking alcohol in moderate amounts has been shown to reduce inflammation, reduce blood clot formation and improve cholesterol levels, all of which are involved in atherosclerosis. It is known that moderate wine consumption is associated with improved cardiovascular health. Other studies have shown a similar effect for other alcoholic drinks such as beer and spirits. However it is not known whether the Brazilian spirit cachaça has the same effect. This study will investigate the levels of substances in the body that are associated with cardiovascular health or disease after periods of moderate consumption of cachaça and red wine, separately, in the same participants.

Who can participate?
Healthy adults who are willing to drink no alcohol for three separate weeks and to drink wine and cachaça daily at the required amounts for 28 days.

What does the study involve?
The participants will be randomly allocated to one of two groups. Both groups will have 7 days of not drinking any alcohol. One group will drink cachaça daily for 28 days and the other group will drink red wine daily for 28 days. Then both groups will drink no alcohol for 7 days, then the group who drank cachaça in the first period will drink red wine daily for 28 days and the the group who drank red wine in the first period will drink cachaça daily for 28 days.

What are the possible benefits and risks of participating?
There will be no payment for those wishing to participate in the study. Alcoholic beverages will be provided by the study. Side effects are the same as related to the consumption of any alcoholic beverage. The abuse of the beverages provided by the study is totally discouraged by the researchers.

Where is the study run from?
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) [Hospital of the Faculty of Medicine of the University of Sao Paulo] (Brazil)

When is the study starting and how long is it expected to run for?
February 2018 to December 2020

Who is funding the study?
Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) [Sao Paulo State Support for Research] (Brazil)

Who is the main contact?
Pedro Henrique de Moraes Cellia, pedrohenriquemcellia@gmail.com

Contact information

Mr Pedro Cellia
Public

Rua Oscar Freire, 2040 / ap 53
São Paulo
05409011
Brazil

ORCiD logoORCID ID 0000-0002-0499-7536
Phone +5511942324656
Email pedrohenriquemcellia@gmail.com
Mr Eduardo Gomes Lima
Scientific

Via Dr. Enéas Carvalho de Aguiar, 44
Bloco 1, Segundo Andar, Sala 2 (aterosclerose)
Cerqueira César
São Paulo
05403-900
Brazil

ORCiD logoORCID ID 0000-0001-8501-9867
Phone +551126615352
Email eduglima@yahoo.com.br
Mr Carlos Vicente Serrano Jr
Scientific

Via Dr. Enéas Carvalho de Aguiar, 44
Bloco 1, Segundo Andar, Sala 2 (aterosclerose)
Cerqueira César
São Paulo
05403-900
Brazil

ORCiD logoORCID ID 0000-0002-9171-1224
Phone +551126615352
Email cvserranojr@gmail.com

Study information

Study designSingle-center, prospective, interventional, controlled, crossover study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet.
Scientific titleRandomized 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.
Study acronymWICAS
Study objectivesCould cachaça positively modify traditional cardiovascular biomarkers in the same proportion as wine?
Ethics approval(s)Approved 07/08/2019, Comissão de Ética para Análise de Projetos de Pesquisa do HCFMUSP [HCFMUSP Research Ethics Committee] (225 Rua Ovídio Pires de Campos, 5th floor, Prédio da Administração, São Paulo, Brazil; +55 2661-7585;cappesq.adm@hc.fm.usp.br), ref: 3.491.738
Health condition(s) or problem(s) studiedAtherosclerosis
InterventionThis 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 with 7 days of abstinence from all alcohol , then a period of 28 days of moderate consumption of red wine or cachaça, then another 7 days of abstinence, then 28 days of the other alcoholic beverage. Beverages will be provided by the study organizers. They will consume 28 g of alcohol (2 servings, equivalent to 90 ml of cachaça 40% or 230 ml of 12% wine) per day for men and 14 g for women (1 serving per day) in the form of wine or cachaça. The total duration of treatment is 5 weeks and there is no additional follow-up.
Intervention typeOther
Primary outcome measureC-reactive Protein (CRP) level in blood at days 7, 35, 42 and 70
Secondary outcome measures1. 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
Overall study start date01/02/2018
Completion date18/11/2020

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Total final enrolment42
Key inclusion criteria1. Aged over 18 years
2. Able to drink alcohol
3. Able to abstain from alcohol for 1 week
Key exclusion criteria1. 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
Date of first enrolment01/11/2019
Date of final enrolment31/07/2020

Locations

Countries of recruitment

  • Brazil

Study participating centre

Instituto do Coração do Hospital das Clínicas de São Paulo (InCor)
Av. Dr. Enéas Carvalho de Aguiar, 44
São Paulo
05403-900
Brazil

Sponsor information

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
Hospital/treatment centre

Av. Dr. Enéas Carvalho de Aguiar, 44
São Paulo
05403-900
Brazil

Phone (+55) 11 2661-5000
Email contato@drpedrohenriquecellia.com.br
Website http://www.incor.usp.br/sites/incor2013/
ROR logo "ROR" https://ror.org/02ddkpn78

Funders

Funder type

Government

Fundação de Amparo à Pesquisa do Estado de São Paulo

No information available

Results and Publications

Intention to publish date31/07/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planTo make data public on 2020 ESC congress
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 27/10/2022 05/12/2022 Yes No

Editorial Notes

05/12/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
04/12/2020: The following changes have been made:
1. The overall trial end date has been changed from 01/12/2020 to 18/11/2020.
2. The intention to publish date has been changed from 01/09/2020 to 31/07/2021.
16/10/2019: Trial's existence confirmed by Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) [Sao Paulo State Support for Research] and Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) [Hospital of the Faculty of Medicine of the University of Sao Paulo].