Back to resultsThe Effect of Beer, Red Wine and Fruit Juice on Blood Vessel Function in Persons With Cardiovascular Disease
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Moderate daily consumption of Red wine
Moderate daily consumption of beer
Moderate consumption of fruit juice rich in polyphenolics
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Heart Disease focused on measuring Alcohol, Red wine, Endothelial function, Flow-mediated vasodilation, Cardiovascular disease
Eligibility Criteria
Inclusion Criteria:
- Men or postmenopausal women with stable coronary heart disease
- Coronary heart disease should be verified by coronary angiography with at least 50% stenosis in at least one coronary vessel.
Exclusion Criteria:
- Patients with myocardial infarction within the last tree months
- Persons with a present or earlier alcohol abuse
- Persons with a present or earlier drug abuse
- Person with malign disease
- Persons, that we consider unsuitable to carry through the examines.
Sites / Locations
- Department of Cardiology, Aalborg Hospital, Science and Innovation Center
Outcomes
Primary Outcome Measures
Changes in flow-mediated vasodilation after 2 weeks intervention compared with baseline
Secondary Outcome Measures
Lipid status after 2 weeks intervention compared with baseline
Effects in Coagulation factors after 2 weeks intervention
Effects on markers of inflammation after 2 weeks intervention
Effects on markers of endothelial function after 2 weeks intervention
Changes in the overall antioxidant activity in plasma after 2 weeks intervention
Full Information
NCT ID
NCT00382551
First Posted
September 28, 2006
Last Updated
January 29, 2009
Sponsor
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00382551
Brief Title
The Effect of Beer, Red Wine and Fruit Juice on Blood Vessel Function in Persons With Cardiovascular Disease
Official Title
The Effect of Alcohol and Polyphenolic Compounds on Endothelial Function
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Aalborg University Hospital
4. Oversight
5. Study Description
Brief Summary
To study the effect of red wine, beer and fruit juice on endothelial function in patients with coronary Heart disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Alcohol, Red wine, Endothelial function, Flow-mediated vasodilation, Cardiovascular disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Moderate daily consumption of Red wine
Intervention Type
Behavioral
Intervention Name(s)
Moderate daily consumption of beer
Intervention Type
Behavioral
Intervention Name(s)
Moderate consumption of fruit juice rich in polyphenolics
Primary Outcome Measure Information:
Title
Changes in flow-mediated vasodilation after 2 weeks intervention compared with baseline
Secondary Outcome Measure Information:
Title
Lipid status after 2 weeks intervention compared with baseline
Title
Effects in Coagulation factors after 2 weeks intervention
Title
Effects on markers of inflammation after 2 weeks intervention
Title
Effects on markers of endothelial function after 2 weeks intervention
Title
Changes in the overall antioxidant activity in plasma after 2 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or postmenopausal women with stable coronary heart disease
Coronary heart disease should be verified by coronary angiography with at least 50% stenosis in at least one coronary vessel.
Exclusion Criteria:
Patients with myocardial infarction within the last tree months
Persons with a present or earlier alcohol abuse
Persons with a present or earlier drug abuse
Person with malign disease
Persons, that we consider unsuitable to carry through the examines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik B Schmidt, Professor
Organizational Affiliation
Department of Cardiology, Aalborg Hospital , Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cardiology, Aalborg Hospital, Science and Innovation Center
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
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The Effect of Beer, Red Wine and Fruit Juice on Blood Vessel Function in Persons With Cardiovascular Disease
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