Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborator:
Ocean Spray, Inc.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00631306
First received: February 28, 2008
Last updated: August 10, 2011
Last verified: August 2011
  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

Resource links provided by NLM:


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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Mayo Clinic

Additional 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
Study First Received: February 28, 2008
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014