Back to results

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

About this trial

This is an interventional basic science trial for Coronary Artery Disease

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT00553904

First Posted

November 5, 2007

Last Updated

June 16, 2009

Sponsor

Boston University

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

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

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

Learn more about this trial

Effect of Cranberry Juice on Endothelial Function

We'll reach out to this number within 24 hrs