Effect of Wine Consumption on Cardiovascular Markers in CHDs Patients
Effect of Light to Moderate Wine Consumption on Cardiovascular Markers in Coronary Heart Disease Patients
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedJune 18, 2020
June 1, 2020
4.8 years
June 16, 2020
June 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Effect on platelet aggregation against PAF
% Change of EC50 value of platelet aggregation against PAF
Changes between baseline, 4 and 8 weeks.
Effect on platelet aggregation against ADP
% Change of EC50 value of platelet aggregation against ADP
Changes between baseline, 4 and 8 weeks.
Effect on platelet aggregation against collagen
% Change of EC50 value of platelet aggregation against collagen
Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers (activity of Lyso-PAF-AT)
% Change in the activity of PAF biosynthetic enzyme Lyso-PAF AT
Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers (activity of PAF-CPT)
% Change in the activity of PAF biosynthetic enzyme PAF-CPT
Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers (activity of PAF-AH)
% Change in the activity of PAF degradation enzyme PAF-AH
Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers (activity of LpPLA2)
% Change in the activity of PAF degradation enzyme Lp-PLA2
Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers
% Changes of Adiponectin, IL-6, CRP
Changes between baseline, 4 and 8 weeks.
Cytokine secretion by PBMC
Secretion of TNFa and IL-1β by PBMC under basal and inflammatory (LPS-induced) conditions at 4 and 24h incubation
Changes between baseline, 4 and 8 weeks.
Effect on endothelial function markers
% Changes of VCAM, P-selectin.
Changes between baseline, 4 and 8 weeks.
Secondary Outcomes (2)
Effect on biochemical indices
Changes between baseline, 4 and 8 weeks.
Effect on oxidative stress markers
Changes between baseline, 4 and 8 weeks.
Study Arms (3)
Red Wine group
ACTIVE COMPARATORParticipants of this group consumed 200ml of red wine along with a meal (lunch or dinner) every day for 8 weeks.
Ethanol group
ACTIVE COMPARATORParticipants of this group consumed 69mL of tsipouro along with a meal (lunch or dinner) every day for 8 weeks.
Control group
NO INTERVENTIONParticipants of this group consumed no alcohol along with a meal (lunch or dinner) every day for 8 weeks
Interventions
Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of any other inflammatory disease, diabetes, presence of cold or flu, acute respiratory infection, dental problems and renal/hepatic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nutrition-Dietetics, Harokopio University
Athens, 17671, Greece
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Biological Chemistry
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 18, 2020
Study Start
September 1, 2013
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
June 18, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share