Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-04 @ 3:50 PM
Study NCT ID:
NCT02802904
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2016-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL)', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer'}], 'secondaryOutcomes': [{'measure': 'changes of serum HDL cholesterol', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer'}, {'measure': 'changes of serum LDL cholesterol', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer'}, {'measure': 'changes of serum Triacylglycerol (TAG)', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer'}, {'measure': 'changes of serum non-esterified fatty acids (NEFA)', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'analysed by ELISA kits'}, {'measure': 'changes of serum LDL sub-fractions', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'analysed with LIPOPRINT System'}, {'measure': 'changes of serum Lp(a)', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer'}, {'measure': 'changes of Blood pressure', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'measured by blood pressure meter'}, {'measure': 'Changes of body mass index (BMI)', 'timeFrame': 'week 0 (baseline) and week 4', 'description': 'measured by Tanita Segmental Body Fat Analysis'}, {'measure': 'changes of Waist circumference', 'timeFrame': 'week 0 (baseline) and week 4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Healthy subjects'], 'conditions': ['Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': 'Fats and oils are made up of \\>90% triacylglycerol fat molecules which consist of a glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations have come to be known as or explained by the "sn-2 hypothesis". New evidence have also emerged to show that saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a rat model. In this proposed study, the effects on the outcome measures investigated of three test fats \\[namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)\\], with oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated', 'detailedDescription': 'To investigate the effects of different dietary fats with primarily oleic acid in the sn-2 position on the cardiovascular risk profile in healthy Malaysian volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy adult male or female, aged 20-50 years\n* BMI 18.5- 24.9 kg/m2 as per WHO Classification (1998)\n\nExclusion criteria:\n\n* Hyperlipidemia (TC\\>6.2 mmol/L, TAG \\>2.0 mmol/L)\n* History of chronic disease- type 2 DM, heart disease, cancer\n* Habitual smokers (\\>2 sticks a day)\n* Hypertensives: \\>140/90 mmHg\n* On medication/nutraceuticals to reduce blood lipids, blood pressure\n* Pregnant or lactating women\n* Planned trip abroad/overseas during period of study'}, 'identificationModule': {'nctId': 'NCT02802904', 'acronym': 'MC1', 'briefTitle': 'Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Malaysia Palm Oil Board'}, 'officialTitle': 'Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers', 'orgStudyIdInfo': {'id': 'PD205/15- STUDY 1 (A)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palm olein IV 64', 'description': 'Palm olein IV 64, n= 15, 4 weeks intervention', 'interventionNames': ['Other: Diet: Palm olein IV64']}, {'type': 'EXPERIMENTAL', 'label': 'Cocoa butter', 'description': 'Cocoa butter, n= 15, 4 weeks intervention', 'interventionNames': ['Other: Diet: Cocoa butter']}, {'type': 'EXPERIMENTAL', 'label': 'Virgin olive oil', 'description': 'Virgin olive oil, n= 15, 4 weeks intervention', 'interventionNames': ['Other: Diet: Virgin olive oil']}], 'interventions': [{'name': 'Diet: Palm olein IV64', 'type': 'OTHER', 'description': 'Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat Palm Olein IV64 which was incorporated into daily snacks (\\~50g of test fats, brownies (\\~15g test fat each) for breakfast and 4 pieces cookies (\\~5g test fat each) with low fat palm olein based background diet daily.', 'armGroupLabels': ['Palm olein IV 64']}, {'name': 'Diet: Cocoa butter', 'type': 'OTHER', 'description': 'Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat cocoa butter which was incorporated into daily snacks (\\~50g of test fats, brownies (\\~15g test fat each) for breakfast and 4 pieces cookies (\\~5g test fat each) with low fat palm olein based background diet daily.', 'armGroupLabels': ['Cocoa butter']}, {'name': 'Diet: Virgin olive oil', 'type': 'OTHER', 'description': 'Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat virgin olive oil which incorporated into daily snacks (\\~50g of test fats, brownies (\\~15g test fat each) for breakfast and 4 pieces cookies (\\~5g test fat each) with low fat palm olein based background diet daily.', 'armGroupLabels': ['Virgin olive oil']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Datuk Dr. Choo Yuen May, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'MPOB'}, {'name': 'Emeritus Prof. Datuk Dr. Augustine Ong Soon Hock, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Malaysian Oil Scientists and Technologists' Association (MOSTA)"}, {'name': 'Assoc Prof Dr Tony Ng Kock Wai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMU'}, {'name': 'Dr Kanga Rani Selvaduray, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MPOB'}, {'name': 'Radhika Loganathan, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MPOB'}, {'name': 'Dr Darren Gouk Siew Wah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MPOB'}, {'name': 'Gowri Nagapan, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MPOB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malaysia Palm Oil Board', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'IMU University, Malaysia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}