Effect of Wine Consumption on Cardiovascular Markers in CHDs Patients
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

Intervention name(s): Cabernet Sauvignon; Tsipouro
Intervention type(s): Other; Other
Intervention description(s): Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.; Tsipouro is a greek spirit which contains 38% alcohol vol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wine; cardiovascular disease; inflammatory biomarkers; platelet aggregation; Platelet Activating Factor; ethanol; PBMCs; Wine microcontsituents