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Effect of Cranberry Juice on Endothelial Function

This study has been completed.
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00553904
First received: November 5, 2007
Last updated: June 16, 2009
Last verified: June 2009
History of Changes
  Purpose

A pilot study of 15 subjects will be completed to determine whether acute consumption of cranberry juice has an effect on endothelial function. We will then complete a randomized, double blind, placebo controlled crossover study designed to investigate the effects of cranberry juice consumption on endothelial function. Participants (n=40) will drink 480 ml of double strength cranberry juice or a similar appearing and tasting placebo per day for four weeks. After a two week rest period, they will cross over to the other beverage. We will examine endothelial function before and after each of the two treatment periods. The study will provide information about the chronic vascular effects of cranberry juice.


Condition Intervention
Coronary Artery Disease
 Dietary Supplement: Cranberry juice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Long-Term Effects of Cranberry Juice on Endothelial Function in Patients With Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carotid-femoral pulse wave velocity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Markers of inflammation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Serum anthocyanins [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Cranberry juice
    480 ml of double strength cranberry juice daily for four weeks
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery disease

Exclusion Criteria:

  • Pregnant and lactating women
  • Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate
  • Treatment with an investigational new drug within the last 30 days
  • History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
  • Treatment with Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 2 weeks of enrollment (subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the RDA will not be excluded).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553904

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston Medical Center
  More Information

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joseph A. Vita, MD, Boston University School of Medicine
ClinicalTrials.gov Identifier: NCT00553904     History of Changes
Other Study ID Numbers: H-26708
Study First Received: November 5, 2007
Last Updated: June 16, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013