Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

Sponsors

Lead Sponsor: Mayo Clinic

Collaborator: Ocean Spray, Inc.

Source Mayo Clinic
Brief Summary

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

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.

Overall Status Completed
Start Date February 2008
Completion Date December 2010
Primary Completion Date December 2009
Study Type Observational
Primary 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. baseline and 4 months post
Secondary Outcome
Measure Time Frame
The current study was also designed to test the acute effect of double-strength cranberry juice on endothelial function. 45 mins post consumption
Enrollment 60
Condition
Eligibility

Sampling Method: Non-Probability Sample

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.).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Amir Lerman, MD Principal Investigator Mayo Clinic
Location
Facility: Mayo Clinic
Location Countries

United States

Verification Date

August 2011

Responsible Party

Name Title: Amir Lerman, MD

Organization: Mayo Clinic

Has Expanded Access No
Condition Browse
Arm Group

Label: Bottle number 615

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

Label: Bottle number 429

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

Study Design Info

Observational Model: Case Control

Time Perspective: Prospective

Source: ClinicalTrials.gov