Effect of Cranberry Juice on Endothelial Function
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranberry juice
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Disease
Eligibility 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).
Sites / Locations
- Boston Medical Center
Outcomes
Primary Outcome Measures
Brachial artery flow-mediated dilation
Secondary Outcome Measures
Carotid-femoral pulse wave velocity
Markers of inflammation
Serum anthocyanins
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00553904
Brief Title
Effect of Cranberry Juice on Endothelial Function
Official Title
Long-Term Effects of Cranberry Juice on Endothelial Function in Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry juice
Intervention Description
480 ml of double strength cranberry juice daily for four weeks
Primary Outcome Measure Information:
Title
Brachial artery flow-mediated dilation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Carotid-femoral pulse wave velocity
Time Frame
1 month
Title
Markers of inflammation
Time Frame
1 month
Title
Serum anthocyanins
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Vita, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21411615
Citation
Dohadwala MM, Holbrook M, Hamburg NM, Shenouda SM, Chung WB, Titas M, Kluge MA, Wang N, Palmisano J, Milbury PE, Blumberg JB, Vita JA. Effects of cranberry juice consumption on vascular function in patients with coronary artery disease. Am J Clin Nutr. 2011 May;93(5):934-40. doi: 10.3945/ajcn.110.004242. Epub 2011 Mar 16.
Results Reference
derived
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Effect of Cranberry Juice on Endothelial Function
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