Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-05 @ 5:07 AM
Study NCT ID:
NCT01264666
Status:
COMPLETED
Last Update Posted:
2010-12-22
First Post:
2010-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-21', 'studyFirstSubmitDate': '2010-12-21', 'studyFirstSubmitQcDate': '2010-12-21', 'lastUpdatePostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum sample', 'timeFrame': '4 hours', 'description': 'blood samples were collected at 0,0.5,1,2,4 hours postprandially to get serum sample.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chinese tea flavor liquor', 'postprandial', 'uric acid', 'high-sensitive C-reactive protein'], 'conditions': ['Alcohols', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor liquor may be beneficial to CVD risk factors postprandially.\n\nDesign: three-way crossover design with one week wash time.16 young men were included to consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45% alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours postprandially.\n\nTested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no CVD history or liver disease, healthy young men\n\nExclusion Criteria:\n\n* smokers'}, 'identificationModule': {'nctId': 'NCT01264666', 'acronym': 'TFL', 'briefTitle': 'Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Phase I Study of Chinese Tea Flavor Liquor on Human Health', 'orgStudyIdInfo': {'id': 'Acute Chinese liquor study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese tea flavor liquor', 'interventionNames': ['Dietary Supplement: Chinese tea flavor liquor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Water', 'description': 'Water combined with meal as control.', 'interventionNames': ['Dietary Supplement: Water control']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Chinese Meijiao Liquor', 'interventionNames': ['Dietary Supplement: Chinese Meijiao liquor']}], 'interventions': [{'name': 'Chinese tea flavor liquor', 'type': 'DIETARY_SUPPLEMENT', 'description': '60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal.', 'armGroupLabels': ['Chinese tea flavor liquor']}, {'name': 'Chinese Meijiao liquor', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Chinese Meijiao Liquor']}, {'name': 'Water control', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310029', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Department of Food Science of Nutrition, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guizhou Meijiao Co., Ltd, China', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Jusheng Zheng', 'oldOrganization': 'Department of food science of nutrition, Zhejiang University'}}}}