Clinical trial NCT04438122: Effect of Wine Consumption on Cardiovascular Markers in CHDs Patients
Official title: Effect of Light to Moderate Wine Consumption on Cardiovascular Markers in Coronary Heart Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: wine
cardiovascular disease
inflammatory biomarkers
platelet aggregation
Platelet Activating Factor
ethanol
PBMCs
Wine microcontsituents
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 57
Sex: MALE
Minimum age (years): 37
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effect on platelet aggregation against PAF
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on platelet aggregation against ADP
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on platelet aggregation against collagen
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on inflammatory markers (activity of Lyso-PAF-AT)
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on inflammatory markers (activity of PAF-CPT)
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on inflammatory markers (activity of PAF-AH)
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on inflammatory markers (activity of LpPLA2)
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on inflammatory markers
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Cytokine secretion by PBMC
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on endothelial function markers
timeFrame: Changes between baseline, 4 and 8 weeks.
Secondary outcomes:
measure: Effect on biochemical indices
timeFrame: Changes between baseline, 4 and 8 weeks.
measure: Effect on oxidative stress markers
timeFrame: Changes between baseline, 4 and 8 weeks.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Nutrition-Dietetics, Harokopio University
Study officials:
References: