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
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