Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease
1 other identifier
observational
60
1 country
1
Brief Summary
This study is being done to determine if the use of double strength cranberry juice in daily diet will improve endothelial function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 12, 2011
August 1, 2011
1.8 years
February 28, 2008
August 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The current study was also designed to test the acute effect of double-strength cranberry juice on endothelial function.
45 mins post consumption
Study Arms (2)
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 Criteria
Mayo Clinic Patients
You may qualify if:
- 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.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Ocean Spray, Inc.collaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Flammer AJ, Martin EA, Gossl M, Widmer RJ, Lennon RJ, Sexton JA, Loeffler D, Khosla S, Lerman LO, Lerman A. Polyphenol-rich cranberry juice has a neutral effect on endothelial function but decreases the fraction of osteocalcin-expressing endothelial progenitor cells. Eur J Nutr. 2013 Feb;52(1):289-96. doi: 10.1007/s00394-012-0334-4. Epub 2012 Mar 2.
PMID: 22382203DERIVED
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Lerman, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
August 12, 2011
Record last verified: 2011-08