Condition category
Circulatory System
Date applied
11/10/2019
Date assigned
01/11/2019
Last edited
01/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Mr Pedro Cellia

ORCID ID

http://orcid.org/0000-0002-0499-7536

Contact details

Rua Oscar Freire
2040 / ap 53
São Paulo
05409011
Brazil
+5511942324656
pedrohenriquemcellia@gmail.com

Type

Scientific

Additional contact

Mr Eduardo Gomes Lima

ORCID ID

http://orcid.org/0000-0001-8501-9867

Contact details

Via Dr. Enéas Carvalho de Aguiar
44
Bloco 1
Segundo Andar
Sala 2 (aterosclerose)
Cerqueira César
São Paulo
05403-900
Brazil
+551126615352
eduglima@yahoo.com.br

Type

Scientific

Additional contact

Mr Carlos Vicente Serrano Jr

ORCID ID

http://orcid.org/0000-0002-9171-1224

Contact details

Via Dr. Enéas Carvalho de Aguiar
44
Bloco 1
Segundo Andar
Sala 2 (aterosclerose)
Cerqueira César
São Paulo
05403-900
Brazil
+551126615352
cvserranojr@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

16758719.6.0000.0068

Study information

Scientific title

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.

Acronym

WICAS

Study hypothesis

Could cachaça positively modify traditional cardiovascular biomarkers in the same proportion as wine?

Ethics approval

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

Study design

Single-center, prospective, interventional, controlled, crossover study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

Atherosclerosis

Intervention

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 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 type

Other

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

01/02/2018

Overall trial end date

01/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/11/2019

Recruitment end date

31/07/2020

Locations

Countries of recruitment

Brazil

Trial 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

Organisation

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

Sponsor details

Av. Dr. Enéas Carvalho de Aguiar
44
São Paulo
05403-900
Brazil
(+55) 11 2661-5000
contato@drpedrohenriquecellia.com.br

Sponsor type

Hospital/treatment centre

Website

http://www.incor.usp.br/sites/incor2013/

Funders

Funder type

Government

Funder name

Fundação de Amparo à Pesquisa do Estado de São Paulo

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To make data public on 2020 ESC congress

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/09/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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].