Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease

NCT ID: NCT00631306

Last Updated: 2011-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Atherosclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bottle number 615

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

No interventions assigned to this group

Bottle number 429

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

No interventions assigned to this group

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ocean Spray, Inc.

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Amir Lerman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22382203 (View on PubMed)

Other Identifiers

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07-003443

Identifier Type: -

Identifier Source: org_study_id

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