Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-29 @ 7:10 AM
Study NCT ID:
NCT01185769
Status:
COMPLETED
Last Update Posted:
2010-08-20
First Post:
2010-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tocotrienol Absorption and Distribution Under Different Fat Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D024508', 'term': 'Tocotrienols'}], 'ancestors': [{'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-19', 'studyFirstSubmitDate': '2010-08-19', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in absorption and distribution of Tocoterienols during high fat and low fat meal by measuring the plasma, chylomicron, and HDL level of tocotrienol', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin E', 'Absorption'], 'conditions': ['Absorption']}, 'descriptionModule': {'briefSummary': 'Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans remains unclear especially with different fat diets.This study aimed at evaluating the absorption and distribution of tocotrienols in plasma and lipoproteins in associations with high and low fat diets. Different fat level will affect the absorption and distribution of tocotrienols', 'detailedDescription': 'There is a possibility that the absorption and distribution of tocotrienols may occur differently compared with tocopherols, especially under different fat status'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male aged 22-25\n* body mass index 18.5 \\< X \\< 30 kg/m2\n* plasma cholesterol \\< 5.2 mmol/L,\n* TAG \\< 1.7 mmol/L\n\nExclusion Criteria:\n\n* history of cardiovascular disease\n* diabetic\n* body mass index \\< 18.5 or \\> 30 kg/m2\n* plasma cholesterol \\> 5.2 mmol/L,\n* TAG \\> 1.7 mmol/L\n* hypertension\n* currently taking Vitamin E supplement\n* current use of medication\n* smoking.'}, 'identificationModule': {'nctId': 'NCT01185769', 'briefTitle': 'Study of Tocotrienol Absorption and Distribution Under Different Fat Status', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Malaysia Palm Oil Board'}, 'officialTitle': 'Mechanism of Absorption and Distribution of Tocotrienols Under Different Food Status', 'orgStudyIdInfo': {'id': 'PD141/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High fat', 'description': '500 mg of tocotrienol will be administered at single dose after consumption of high fat diet', 'interventionNames': ['Dietary Supplement: Tocotrienol']}, {'type': 'EXPERIMENTAL', 'label': 'Low fat', 'description': '500 mg of tocotrienol will be administered at single dose after consumption of low fat diet', 'interventionNames': ['Dietary Supplement: Tocotrienol']}], 'interventions': [{'name': 'Tocotrienol', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg of tocotrienol will be administered after consumption of high fat diet', 'armGroupLabels': ['High fat']}, {'name': 'Tocotrienol', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg of tocotrienol will be administered after consumption of low fat diet', 'armGroupLabels': ['Low fat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43000', 'city': 'Bangi', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Malaysian Palm Oil Board', 'geoPoint': {'lat': 2.9, 'lon': 101.78333}}], 'overallOfficials': [{'name': 'Weng-Yew Wong, Bsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Malaysia Palm Oil Board'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malaysia Palm Oil Board', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Malaya', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Wong Weng-Yew / Research Officer', 'oldOrganization': 'Malaysian Palm Oil Board'}}}}