Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT00631306
Status:
COMPLETED
Last Update Posted:
2011-08-12
First Post:
2008-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-10', 'studyFirstSubmitDate': '2008-02-28', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'baseline and 4 months post'}], 'secondaryOutcomes': [{'measure': 'The current study was also designed to test the acute effect of double-strength cranberry juice on endothelial function.', 'timeFrame': '45 mins post consumption'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '22382203', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to determine if the use of double strength cranberry juice in daily diet will improve endothelial function.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mayo Clinic Patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Subjects with no known history of cardiac disease will also be eligible to participate.\n* 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.\n\nExclusion Criteria:\n\n* 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.).'}, 'identificationModule': {'nctId': 'NCT00631306', 'briefTitle': 'Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease', 'orgStudyIdInfo': {'id': '07-003443'}}, 'armsInterventionsModule': {'armGroups': [{'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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Amir Lerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ocean Spray, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Amir Lerman, MD', 'oldOrganization': 'Mayo Clinic'}}}}