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NCT00382551 Clinical Trial

The Effect of Beer, Red Wine and Fruit Juice on Blood Vessel Function in Persons With Cardiovascular Disease

Coronary Heart Disease Clinical Trial

Official title:
The Effect of Alcohol and Polyphenolic Compounds on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00382551
Other study ID # VN-20060043
Secondary ID
Status Completed
Phase Phase 0
First received September 28, 2006
Last updated January 29, 2009
Start date October 2006

Study information
Verified date January 2009
Source Aalborg Universitetshospital
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of HealthDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

To study the effect of red wine, beer and fruit juice on endothelial function in patients with coronary Heart disease.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Moderate daily consumption of Red wine

• Moderate daily consumption of beer

• Moderate consumption of fruit juice rich in polyphenolics

Locations
Country Name City State
Denmark Department of Cardiology, Aalborg Hospital, Science and Innovation Center Aalborg

Sponsors (1)
Lead Sponsor Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in flow-mediated vasodilation after 2 weeks intervention compared with baseline
Secondary Lipid status after 2 weeks intervention compared with baseline
Secondary Effects in Coagulation factors after 2 weeks intervention
Secondary Effects on markers of inflammation after 2 weeks intervention
Secondary Effects on markers of endothelial function after 2 weeks intervention
Secondary Changes in the overall antioxidant activity in plasma after 2 weeks intervention
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