Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-02-11 @ 8:58 AM
Study NCT ID:
NCT00553904
Status:
COMPLETED
Last Update Posted:
2009-06-18
First Post:
2007-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cranberry Juice on Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-16', 'studyFirstSubmitDate': '2007-11-05', 'studyFirstSubmitQcDate': '2007-11-05', 'lastUpdatePostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brachial artery flow-mediated dilation', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Carotid-femoral pulse wave velocity', 'timeFrame': '1 month'}, {'measure': 'Markers of inflammation', 'timeFrame': '1 month'}, {'measure': 'Serum anthocyanins', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '21411615', 'type': 'DERIVED', 'citation': 'Dohadwala MM, Holbrook M, Hamburg NM, Shenouda SM, Chung WB, Titas M, Kluge MA, Wang N, Palmisano J, Milbury PE, Blumberg JB, Vita JA. Effects of cranberry juice consumption on vascular function in patients with coronary artery disease. Am J Clin Nutr. 2011 May;93(5):934-40. doi: 10.3945/ajcn.110.004242. Epub 2011 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'A pilot study of 15 subjects will be completed to determine whether acute consumption of cranberry juice has an effect on endothelial function. We will then complete a randomized, double blind, placebo controlled crossover study designed to investigate the effects of cranberry juice consumption on endothelial function. Participants (n=40) will drink 480 ml of double strength cranberry juice or a similar appearing and tasting placebo per day for four weeks. After a two week rest period, they will cross over to the other beverage. We will examine endothelial function before and after each of the two treatment periods. The study will provide information about the chronic vascular effects of cranberry juice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Coronary artery disease\n\nExclusion Criteria:\n\n* Pregnant and lactating women\n* Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate\n* Treatment with an investigational new drug within the last 30 days\n* History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.\n* Treatment with Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 2 weeks of enrollment (subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the RDA will not be excluded)."}, 'identificationModule': {'nctId': 'NCT00553904', 'briefTitle': 'Effect of Cranberry Juice on Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Long-Term Effects of Cranberry Juice on Endothelial Function in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'H-26708'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cranberry juice', 'type': 'DIETARY_SUPPLEMENT', 'description': '480 ml of double strength cranberry juice daily for four weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Joseph A Vita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joseph A. Vita, MD', 'oldOrganization': 'Boston University School of Medicine'}}}}