Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-28 @ 4:02 PM
Study NCT ID:
NCT02087735
Status:
COMPLETED
Last Update Posted:
2016-10-10
First Post:
2014-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Urinary Catabolites of PACs as Biomarkers of Consumption of Cranberry Extracts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2014-03-13', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary catabolites of PACs', 'timeFrame': 'within 9 hours following the intake of cranberry extracts'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cranberry', 'Proanthocyanidins', 'Urinary catabolites'], 'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this cross over pilot study is to investigate the urinary catabolites of Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women.\n* 18 to 40 years.\n\nExclusion Criteria:\n\n* No internet access.\n* No refrigerator access during the 9 hours of sample collection.\n* Women who had or expect to take antibiotic.\n* Women who had or expect to take cranberries, blueberries or bilberries in the form of berries, juice or extracts.\n* Women who had or expect to take dark chocolate.\n* Women who had personal history of acute or chronic renal failure.'}, 'identificationModule': {'nctId': 'NCT02087735', 'acronym': 'CUPACS', 'briefTitle': 'Measurement of Urinary Catabolites of PACs as Biomarkers of Consumption of Cranberry Extracts', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Measurement of Urinary Catabolites of the Proanthocyanidines (PACs) in Healthy Young Women as Biomarkers of Consumption of Cranberry Extracts.', 'orgStudyIdInfo': {'id': 'PACS-2013-SD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cranberry extract 1', 'description': 'One capsule with a proanthocyanidin standardized cranberry extract of 36 mg and one capsule of placebo cranberry extract.', 'interventionNames': ['Dietary Supplement: Cranberry extract']}, {'type': 'EXPERIMENTAL', 'label': 'cranberry extract 2.', 'description': 'Two capsules with a proanthocyanidin standardized cranberry extract of 36 mg.', 'interventionNames': ['Dietary Supplement: Cranberry extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cranberry extract 3.', 'description': 'Two capsules with a proanthocyanidin standardized cranberry extract of 2 mg.', 'interventionNames': ['Dietary Supplement: Cranberry extract']}], 'interventions': [{'name': 'Cranberry extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The aim of this pilot study is to evaluate the urinary catabolites of PACs as a biomarker of consumption of cranberry extracts within 9 hours of intercourse. Once a week, for 3 weeks, the women will receive a sequence of 3 different cranberry extracts (72 mg, 36 mg and 2mg (placebo)). The participant will have to collect its urine for a period of 9 hours in 3 different containers (one different container for 3 hours).', 'armGroupLabels': ['cranberry extract 1', 'cranberry extract 2.', 'cranberry extract 3.']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 0A6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Laval University, Department of Medecine, Institut sur la nutrition et les aliments fonctionnels (INAF).', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Sylvie Dodin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sylvie Dodin, MD', 'investigatorFullName': 'Sylvie Dodin', 'investigatorAffiliation': 'Laval University'}}}}