NCT00382551

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

First QC Date

September 28, 2006

Last Update Submit

January 29, 2009

Conditions

Coronary Heart Disease

Keywords

AlcoholRed wineEndothelial functionFlow-mediated vasodilationCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Changes in flow-mediated vasodilation after 2 weeks intervention compared with baseline

Secondary Outcomes (5)

  • 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

Interventions

Moderate daily consumption of Red wineBEHAVIORAL
Moderate daily consumption of beerBEHAVIORAL
Moderate consumption of fruit juice rich in polyphenolicsBEHAVIORAL

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Aalborg Hospital, Science and Innovation Center

Aalborg, Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Coronary DiseaseCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular Diseases

Study Officials

  • Erik B Schmidt, Professor

    Department of Cardiology, Aalborg Hospital , Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

October 1, 2006

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

DK(1)