Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

August 10, 2011 updated by: Mayo Clinic
This study is being done to determine if the use of double strength cranberry juice in daily diet will improve endothelial function.

Study Overview

Status

Completed

Conditions

Detailed Description

Study participants will be randomized assigned to drink either placebo (a drink that looks and tastes like cranberry juice, but does not contain cranberry juice) or a double strength Ocean Spray light cranberry juice cocktail for four months.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mayo Clinic Patients

Description

Inclusion Criteria:

  • Subjects over the age of 18 years old with known or suspected cardiovascular disease including documented CAD by cardiac catheterization, and multiple cardiovascular risk factors will be included, regardless of severity of endothelial dysfunction or previous history of cardiovascular events.
  • Subjects with no known history of cardiac disease will also be eligible to participate.
  • Subjects must demonstrate endothelial dysfunction via the RH-PAT test (an RH-PAT score of less than 2.0) to continue participating in this study.

Exclusion Criteria:

  • Patients will be excluded if they have confounding factors including, but not limited to, history of renal or liver failure, or relevant food allergies (cranberries, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Bottle number 615
Patients are randomized to either Bottle number 615 or Bottle number 429 (actual product vs. placebo). This is a blinded study.
Bottle number 429
Patients are randomized to either Bottle number 615 or Bottle number 429 (actual product vs. placebo). This is a blinded study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The current study was designed to test the hypothesis that the chronic administration of supplementation with double-strength cranberry juice will improve peripheral endothelial dysfunction.
Time Frame: baseline and 4 months post
baseline and 4 months post

Secondary Outcome Measures

Outcome Measure
Time Frame
The current study was also designed to test the acute effect of double-strength cranberry juice on endothelial function.
Time Frame: 45 mins post consumption
45 mins post consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Ocean Spray, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 12, 2011

Last Update Submitted That Met QC Criteria

August 10, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-003443

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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