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Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631306
First Posted: March 7, 2008
Last Update Posted: August 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ocean Spray, Inc.
Information provided by:
Mayo Clinic
  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: Observational Model: Case Control
Time Perspective: 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 ]

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 ]

Biospecimen Retention:   Samples Without DNA
blood

Estimated Enrollment: 60
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: December 2009 (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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631306


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Ocean Spray, Inc.
Investigators
Principal Investigator: Amir Lerman, MD Mayo Clinic
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amir Lerman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00631306     History of Changes
Other Study ID Numbers: 07-003443
First Submitted: February 28, 2008
First Posted: March 7, 2008
Last Update Posted: August 12, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases