Skip to main content
OpenTrials
Completed

NCT Number: NCT04438122

Effect of Wine Consumption on Cardiovascular Markers in CHDs Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

37 year–82 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition-Dietetics, Harokopio University

Athens, 17671, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • positive stress test
  • positive myocardial perfusion scintigraphy with Thallium
  • 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.

Treatment and study plan

Cabernet Sauvignon

Other

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

Tsipouro

Other

Tsipouro is a greek spirit which contains 38% alcohol vol

Primary outcomes

  1. Effect on platelet aggregation against PAF

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Change of EC50 value of platelet aggregation against PAF

  2. Effect on platelet aggregation against ADP

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Change of EC50 value of platelet aggregation against ADP

  3. Effect on platelet aggregation against collagen

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Change of EC50 value of platelet aggregation against collagen

  4. Effect on inflammatory markers (activity of Lyso-PAF-AT)

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Change in the activity of PAF biosynthetic enzyme Lyso-PAF AT

  5. Effect on inflammatory markers (activity of PAF-CPT)

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Change in the activity of PAF biosynthetic enzyme PAF-CPT

  6. Effect on inflammatory markers (activity of PAF-AH)

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Change in the activity of PAF degradation enzyme PAF-AH

  7. Effect on inflammatory markers (activity of LpPLA2)

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Change in the activity of PAF degradation enzyme Lp-PLA2

  8. Effect on inflammatory markers

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Changes of Adiponectin, IL-6, CRP

  9. Cytokine secretion by PBMC

    Time frame: Changes between baseline, 4 and 8 weeks.

    Secretion of TNFa and IL-1β by PBMC under basal and inflammatory (LPS-induced) conditions at 4 and 24h incubation

  10. Effect on endothelial function markers

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Changes of VCAM, P-selectin.

Secondary outcomes

  1. Effect on biochemical indices

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Changes of Total cholesterol, LDL-chol, HDL-chol, triacylglycerols, uric acid, glucose, insulin, SGOT/AST, SGPT/ALT, γ-GT

  2. Effect on oxidative stress markers

    Time frame: Changes between baseline, 4 and 8 weeks.

    % Changes of TBARS, Lag time, GPx

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Registry information

Official study title

Effect of Light to Moderate Wine Consumption on Cardiovascular Markers in Coronary Heart Disease Patients

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2020
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.