- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438122
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Athens, Greece, 17671
- Department of Nutrition-Dietetics, Harokopio University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Red Wine group
Participants of this group consumed 200ml of red wine along with a meal (lunch or dinner) every day for 8 weeks.
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Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.
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Active Comparator: Ethanol group
Participants of this group consumed 69mL of tsipouro along with a meal (lunch or dinner) every day for 8 weeks.
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Tsipouro is a greek spirit which contains 38% alcohol vol
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No Intervention: Control group
Participants of this group consumed no alcohol along with a meal (lunch or dinner) every day for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on platelet aggregation against PAF
Time Frame: Changes between baseline, 4 and 8 weeks.
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% Change of EC50 value of platelet aggregation against PAF
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Changes between baseline, 4 and 8 weeks.
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Effect on platelet aggregation against ADP
Time Frame: Changes between baseline, 4 and 8 weeks.
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% Change of EC50 value of platelet aggregation against ADP
|
Changes between baseline, 4 and 8 weeks.
|
Effect on platelet aggregation against collagen
Time Frame: Changes between baseline, 4 and 8 weeks.
|
% Change of EC50 value of platelet aggregation against collagen
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Changes between baseline, 4 and 8 weeks.
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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
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Changes between baseline, 4 and 8 weeks.
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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
|
Changes between baseline, 4 and 8 weeks.
|
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
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Changes between baseline, 4 and 8 weeks.
|
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
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Changes between baseline, 4 and 8 weeks.
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Effect on inflammatory markers
Time Frame: Changes between baseline, 4 and 8 weeks.
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% Changes of Adiponectin, IL-6, CRP
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Changes between baseline, 4 and 8 weeks.
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Cytokine secretion by PBMC
Time Frame: Changes between baseline, 4 and 8 weeks.
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Secretion of TNFa and IL-1β by PBMC under basal and inflammatory (LPS-induced) conditions at 4 and 24h incubation
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Changes between baseline, 4 and 8 weeks.
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Effect on endothelial function markers
Time Frame: Changes between baseline, 4 and 8 weeks.
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% Changes of VCAM, P-selectin.
|
Changes between baseline, 4 and 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Changes between baseline, 4 and 8 weeks.
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Effect on oxidative stress markers
Time Frame: Changes between baseline, 4 and 8 weeks.
|
% Changes of TBARS, Lag time, GPx
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Changes between baseline, 4 and 8 weeks.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HarokopioU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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