Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:41 PM
Study NCT ID:
NCT01533857
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2012-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-12', 'studyFirstSubmitDate': '2012-02-05', 'studyFirstSubmitQcDate': '2012-02-12', 'lastUpdatePostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of selected phenolic acids', 'timeFrame': 'up to 30 hrs'}], 'secondaryOutcomes': [{'measure': 'plasma concentration of selected flavonoid metabolites', 'timeFrame': 'up to 30 hrs'}, {'measure': 'Identification of unknown phenolic acids (metabolites of black tea) in plasma', 'timeFrame': 'up to 30 hrs', 'description': 'It is still largely unknown which metabolites are formed in-vivo after black tea ingestions and circulating in human plasma. Untargeted profiling using LC-MS of plasma samples will be used to identify yet unknown polyphenols / phenolics and their conjugates in plasma and thus extent the hit-list of known metabolites in circulation after black tea consumption'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Black tea', 'phenolic acids'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '24673575', 'type': 'DERIVED', 'citation': 'van Duynhoven J, van der Hooft JJ, van Dorsten FA, Peters S, Foltz M, Gomez-Roldan V, Vervoort J, de Vos RC, Jacobs DM. Rapid and sustained systemic circulation of conjugated gut microbial catabolites after single-dose black tea extract consumption. J Proteome Res. 2014 May 2;13(5):2668-78. doi: 10.1021/pr5001253. Epub 2014 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy males\n* not smoking\n\nExclusion Criteria:\n\n* use of NSAIDS and/or antibiotics\n* no blood donation 1 months prior to screening'}, 'identificationModule': {'nctId': 'NCT01533857', 'briefTitle': 'Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea', 'orgStudyIdInfo': {'id': 'FDS-BNH-0379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Black tea', 'description': 'black tea', 'interventionNames': ['Dietary Supplement: Black tea and phenolic acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: hot water']}], 'interventions': [{'name': 'hot water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hot water and placebo capsule', 'armGroupLabels': ['placebo']}, {'name': 'Black tea and phenolic acids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Black tea extract and capsule with phenolic acids', 'armGroupLabels': ['Black tea']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gières', 'country': 'France', 'facility': 'Optimed Eurofins', 'geoPoint': {'lat': 45.17997, 'lon': 5.78935}}], 'overallOfficials': [{'name': 'Yves Donazzolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurofins Optimed'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}