Effect of Wine Consumption on Cardiovascular Markers in CHDs Patients

NCT ID: NCT04438122

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-06-30

Brief Summary

Many epidemiological studies support that 20-30gr of alcohol consumption per day is related with lower risk for cardiovascular diseases, heart attack as well as mortality related to these diseases. Since the French paradox was reported, a number of experimental and clinical studies have demonstrated the protective effect of red wine compared to other alcoholic drinks on different pathways of the pathogenesis of atherosclerosis. The investigator's previous results revealed that wine contain micro-constituents that exert potent in vitro anti-platelet and anti-inflammatory actions. Also, the wine consumption along with a standardized meal reduced platelet aggregation and biosynthesis of Platelet Activating Factor in healthy men.

Although a large number of studies have reported protective effect of wine against atherosclerosis in healthy people there are few data about the effect of long-term moderate wine consumption in population with CVD. Therefore, the aim of this randomized, intervention clinical study, with control group was to report the effects of regular light to moderate wine consumption on cardiovascular biomarkers in people with CVD.

Detailed Description

The study was a randomized, controlled, three-arm parallel intervention study, designed to evaluate if the light to moderate wine consumption could modulate thrombosis and inflammation, in patients with cardiovascular disease. The study was carried out in accordance with the guidelines laid down in the Declaration of Helsinki (1989) of the World Medical Association and was approved by the Bioethics Committee of Harokopio University. Seventy one men patients with cardiovascular disease were initially recruited to participate in the study. The recruitment took place in several hospitals of Athens in Greece under the supervisor of corresponding cardiologist. Finally 64 met the inclusion criteria. Prior to intervention all participants signed an informed consent All volunteers followed an initial 15 days wash-out period, abstaining from alcohol; then, they randomly assigned to one of the three intervention groups. The randomization code was prepared by a staff member who was not involved in running the trial, by using computer-generated random numbers. Subjects instructed to follow their usual diet and not change their medication during the study. In Group A (control group), participants consumed no alcohol, in Group B (ethanol group) participants consumed 69 mL of tsipouro with 38% alcohol and participants in Group C consumed 200ml of red wine (Cabernet Sauvignon 13.5% alcohol vol.). The ethanol that was consumed in the last two groups was equal at 27gr of ethanol per day and alcoholic beverage was consumed along with the meal (lunch or dinner). Finally, 57 participants completed the study, in particular 20 in Group A, 16 in Group B and 21 in Group C. Intervention lasted two months and biological samples (blood, urine) were collected at the beginning (0 week), in the middle (4 week) and in the end (8 week) of each intervention.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Red Wine group

Participants of this group consumed 200ml of red wine along with a meal (lunch or dinner) every day for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Cabernet Sauvignon

Intervention Type: OTHER

Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.

Ethanol group

Participants of this group consumed 69mL of tsipouro along with a meal (lunch or dinner) every day for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Tsipouro

Intervention Type: OTHER

Tsipouro is a greek spirit which contains 38% alcohol vol

Control group

Participants of this group consumed no alcohol along with a meal (lunch or dinner) every day for 8 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cabernet Sauvignon

Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.

Intervention Type: OTHER

Tsipouro

Tsipouro is a greek spirit which contains 38% alcohol vol

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

The presence of Coronary Heart disease established by angiography or the presence of one of the following:

1. positive stress test

2. positive myocardial perfusion scintigraphy with Thallium

3. positive triplex heart ultrasound with Dobutamine

If nothing of the criteria above existed then hospitalization because of myocardial infarction or stroke.

Stable medication for at least 6 months.

Habit to drink 10-28gr of alcohol per week.

Exclusion Criteria

History of any other inflammatory disease, diabetes, presence of cold or flu, acute respiratory infection, dental problems and renal/hepatic diseases.

• Minimum Eligible Age: 37 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Fragopoulou

Assistant Professor of Biological Chemistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Nutrition-Dietetics, Harokopio University

Athens, , Greece

Countries

Greece

Other Identifiers

HarokopioU

Identifier Type: -

Identifier Source: org_study_id