Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT01789359
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2013-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anthocyanins and Phase 2 anthocyanin conjugates in urine', 'timeFrame': '5 weeks'}], 'secondaryOutcomes': [{'measure': 'White blood cell gene expression at start and end of study', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anthocyanin', 'bioavailability', 'urine', 'long-term'], 'conditions': ['Bioavailability']}, 'referencesModule': {'references': [{'pmid': '24432743', 'type': 'DERIVED', 'citation': 'Kalt W, Liu Y, McDonald JE, Vinqvist-Tymchuk MR, Fillmore SA. Anthocyanin metabolites are abundant and persistent in human urine. J Agric Food Chem. 2014 May 7;62(18):3926-34. doi: 10.1021/jf500107j. Epub 2014 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. To examine how anthocyanin absorption and metabolism may be affected this study will examine urinary excretion of anthocyanins over one month, followed by a one week washout, and then one more dose of blueberry juice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provided written consent (see: Information and Consent Form)\n* Fluent in English\n* Complete a confidential medical questionnaire (Appendix 6)\n* Able and willing to abide by the dietary restrictions as described\n* Able and willing to abide by the urine collection protocols as described\n\nExclusion Criteria:\n\n* No written consent\n* No confidential medical questionnaire\n* Unable to comply with diet restrictions and other study requirements'}, 'identificationModule': {'nctId': 'NCT01789359', 'briefTitle': 'Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Atlantic Food and Horticulture Research Center'}, 'officialTitle': 'Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding', 'orgStudyIdInfo': {'id': 'BBAnthoUrine'}, 'secondaryIdInfos': [{'id': 'AAFC-WBANA', 'type': 'OTHER_GRANT', 'domain': 'Agriculture & Agri-Food Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'anthocyanin-free diet', 'description': 'Maintain anthocyanin-free diet throughout study. Day 1 to day 30, consume daily 250 ml single strength blueberry juice containing 229 mg anthocyanins, taken either as 1 morning dose or 1/3 dose morning, 1/3 mid-day and 1/3 evening. At d 31-38 continue anthocyanin-free diet. On d 39 consume daily dose.', 'interventionNames': ['Other: Blueberry Juice']}], 'interventions': [{'name': 'Blueberry Juice', 'type': 'OTHER', 'otherNames': ['Single strength wild blueberry juice, commercially prepared.'], 'description': 'Dietary intervention', 'armGroupLabels': ['anthocyanin-free diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B4N 1J5', 'city': 'Kentville', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Atlantic Food & Horticulture Research Centre', 'geoPoint': {'lat': 45.0771, 'lon': -64.49605}}], 'overallOfficials': [{'name': 'Wilhelmina - Kalt, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Scientist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Food and Horticulture Research Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}