Effect of Cranberry Juice on Endothelial Function

Coronary Artery Disease Clinical Trial

Official title:

Long-Term Effects of Cranberry Juice on Endothelial Function in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553904
• Other study ID #: H-26708
• Status: Completed
• Phase: N/A
• First received: November 5, 2007
• Last updated: June 16, 2009
• Start date: February 2008
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery flow-mediated dilation		1 month	No
Secondary	Carotid-femoral pulse wave velocity		1 month	No
Secondary	Markers of inflammation		1 month	No
Secondary	Serum anthocyanins		1 month	No