Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-31 @ 7:18 PM
Study NCT ID:
NCT01294995
Status:
COMPLETED
Last Update Posted:
2011-02-14
First Post:
2011-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Short-term Chinese Tea-flavor Liquor Consumption
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-11', 'studyFirstSubmitDate': '2011-02-11', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['short term consumption', 'Chinese liquor', 'serum lipids', 'uric acid', 'inflammation biomarkers'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor fermented from above 5 grains plus green tea.\n\nForty-five volunteers(23 males, 22 females) were selected to participate a paralleled randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids, inflammation biomarkers and CVD risk factors.\n\nTFL could significantly decrease systolic blood pressure of males, but increase diastolic blood pressure of females. TFL could also decreased blood lipid of volunteers, especially for females. Both liquor significantly decrease serum uric acid and glucose in males and females. The effect of the two liquors on inflammation biomarkers were complicated and needs further research work.\n\nTFL may possess more beneficial effect on CVD risk factors than GML probably because of the special fermentation products of green tea with other grains.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female volunteers\n\nExclusion Criteria:\n\n* Subjects with a history of liver disease, diabetes, or heart disease\n* Smokers'}, 'identificationModule': {'nctId': 'NCT01294995', 'acronym': 'ESTCTFLC', 'briefTitle': 'Effect of Short-term Chinese Tea-flavor Liquor Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Phase 1 Study of Chinese Tea-flavor Liquor', 'orgStudyIdInfo': {'id': 'ST Chinese liquor study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tea-flavor Liquor, taken with meal', 'description': 'including 12 males and 11 females', 'interventionNames': ['Dietary Supplement: Tea-flavor Liquor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Guizhou Meijiao Liquor, taken with meal', 'description': 'including 11 males and 11 females', 'interventionNames': ['Dietary Supplement: Guizhou Meijiao Liquor']}], 'interventions': [{'name': 'Tea-flavor Liquor', 'type': 'DIETARY_SUPPLEMENT', 'description': '30 mL of Tea-flavor Liquor(45% alcohol content)', 'armGroupLabels': ['Tea-flavor Liquor, taken with meal']}, {'name': 'Guizhou Meijiao Liquor', 'type': 'DIETARY_SUPPLEMENT', 'description': '30 mL of Guizhou Meijiao Liquor (45% alcohol content)', 'armGroupLabels': ['Guizhou Meijiao Liquor, taken with meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310029', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Department of food science and nutrition', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guizhou Meijiao Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Department of Food Science and Nutrition', 'oldOrganization': 'Department of Food Science and Nutrition'}}}}