Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease
This study has been completed.
Sponsor:
Mayo Clinic
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
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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 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 May 23, 2013