Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

Atherosclerosis Clinical Trial

Official title:

Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631306
• Other study ID #: 07-003443
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: August 10, 2011
• Start date: February 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Ocean Spray, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The current study was also designed to test the acute effect of double-strength cranberry juice on endothelial function.		45 mins post consumption	No

External Links

•   Mayo Clinic Clinical Trials