Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01008020
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2009-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-14', 'studyFirstSubmitDate': '2009-10-29', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence rates of influenza infection', 'timeFrame': 'Until 5 months consumption of the study capsules'}], 'secondaryOutcomes': [{'measure': 'the incidence rates of upper respiratory tract infections', 'timeFrame': 'Until 5 months consumption of the study capsules'}, {'measure': 'the severity of the symptoms and the duration of the cold among incident cases', 'timeFrame': 'Until 5 months consumption of the study capsules'}, {'measure': 'occurrence of the adverse events', 'timeFrame': 'Until 5 months consumption of the study capsules'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tea catechin extracts', 'influenza infection', 'prophylaxis', 'supplements', 'adults over 20 years old', 'both men and women'], 'conditions': ['Influenza Infection']}, 'referencesModule': {'references': [{'pmid': '21338496', 'type': 'DERIVED', 'citation': 'Matsumoto K, Yamada H, Takuma N, Niino H, Sagesaka YM. Effects of green tea catechins and theanine on preventing influenza infection among healthcare workers: a randomized controlled trial. BMC Complement Altern Med. 2011 Feb 21;11:15. doi: 10.1186/1472-6882-11-15.'}]}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.', 'detailedDescription': 'Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent experimental studies have revealed that tea catechin extracts prevent influenza infection, but few studies have been conducted on the clinical effects of tea catechin consumption on the prophylaxis of influenza infection. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of 5 months tea catechin consumption on the prophylaxis of influenza infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged over 20 years\n* possible to maintain without drinking tea more than 250 ml per day during the study\n* possible to maintain without taking supplements or herbal products including catechin extracts during the study\n* possible to fill out a questionnaire personally\n* Obtained written informed consent before participation\n\nExclusion Criteria:\n\n* Possessing some chronic infectious diseases in need of therapy\n* Possessing tea or catechin allergy\n* Possessing a history of influenza infection before six months prior to the study\n* diagnosed as inadequate for other reasons to participate the study by principal investigator'}, 'identificationModule': {'nctId': 'NCT01008020', 'briefTitle': 'Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Shizuoka'}, 'officialTitle': 'A Randomized Controlled Study on the Effects of Tea Catechin Consumption on the Prevention of Influenza Infection in Healthy Adults', 'orgStudyIdInfo': {'id': 'CT2009002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Dietary supplement: placebo'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tea catechin extracts', 'interventionNames': ['Dietary Supplement: tea catechin extracts']}], 'interventions': [{'name': 'tea catechin extracts', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Tea catechin extracts 540 mg/day, are consumed for 5 months.', 'armGroupLabels': ['Tea catechin extracts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '189-0021', 'city': 'Higashimurayama', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'White Cross Nursing Home', 'geoPoint': {'lat': 35.75459, 'lon': 139.46852}}], 'overallOfficials': [{'name': 'Hiroshi Yamada, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Shizuoka'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masahiro Morikawa', 'class': 'OTHER'}, 'collaborators': [{'name': 'White Cross Nursing Home', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Trials management office', 'investigatorFullName': 'Masahiro Morikawa', 'investigatorAffiliation': 'University of Shizuoka'}}}}