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Effect of Cranberry Juice on Endothelial Function

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ClinicalTrials.gov Identifier: NCT00553904
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : June 18, 2009
Information provided by:
Boston University

Brief Summary:
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 or disease Intervention/treatment
Coronary Artery Disease Dietary Supplement: Cranberry juice

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Long-Term Effects of Cranberry Juice on Endothelial Function in Patients With Coronary Artery Disease
Study Start Date : February 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Dietary Supplement: Cranberry juice
    480 ml of double strength cranberry juice daily for four weeks

Primary Outcome Measures :
  1. Brachial artery flow-mediated dilation [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Carotid-femoral pulse wave velocity [ Time Frame: 1 month ]
  2. Markers of inflammation [ Time Frame: 1 month ]
  3. Serum anthocyanins [ Time Frame: 1 month ]

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553904

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

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
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009

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