Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease - Full Text View

Sponsors and Collaborators:	Mayo Clinic Ocean Spray, Inc.
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00631306

Purpose

This study is being done to determine if the use of double strength cranberry juice in daily diet will improve endothelial function.

Condition
Atherosclerosis

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

blood

Estimated Enrollment:	60
Study Start Date:	February 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Study Population

Mayo Clinic Patients

Criteria

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.).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631306

Contacts

Contact: Jennifer Schreiber, BS

507-255-2649

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Schreiber, BS 507-255-2649 schreiber.jennifer@mayo.edu
Contact: Becky Nelson, CCRC 507-255-8388 nelson.rebecca@mayo.edu
Principal Investigator: Amir Lerman, MD

Sponsors and Collaborators

Mayo Clinic

Ocean Spray, Inc.

Investigators

Principal Investigator:

Amir Lerman, MD

Mayo Clinic

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Clinic ( Amir Lerman, MD )
Study ID Numbers:	07-003443
Study First Received:	February 28, 2008
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00631306
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009