Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-07 @ 10:10 PM
Study NCT ID:
NCT02029833
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Canola Oil Multi-Centre Intervention Trial II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal imaging of visceral and subcutaneous abdominal fat', 'timeFrame': '6 weeks', 'description': 'Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.'}], 'secondaryOutcomes': [{'measure': 'Analysis of fatty acid ethanolamides and precursors', 'timeFrame': '6 weeks', 'description': 'Analysis of FAEs in the blood after consumption of treatment oils. UPLC-MS/MS will be used for FAE measurement.'}, {'measure': 'Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels', 'timeFrame': '6 weeks', 'description': 'Analysis of blood levels after consumption of treatment oils. Abbott Spectrum CCX Analyzer utilizing enzymatic reagents will be used to analyzed these measurements.'}, {'measure': 'Plasma insulin level', 'timeFrame': '6 weeks', 'description': 'Assessment of the change in insulin levels after consumption of treatment oils. This measurement will be analyzed by commercially available ELISA kits'}, {'measure': 'Plasma glucose level', 'timeFrame': '6 weeks', 'description': 'Assessment of changes in fasting glucose levels after consumption of treatment oils. This measurement will be analyzed by Abbott Spectrum CCX Analyzer'}, {'measure': 'Plasma C-reactive protein level', 'timeFrame': '6 weeks', 'description': 'Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits'}, {'measure': 'Plasma cytokines level', 'timeFrame': '6 weeks', 'description': 'Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits'}, {'measure': 'Plant sterols and precursors of cholesterol', 'timeFrame': '6 weeks', 'description': 'Analysis of plasma levels after consumption of treatment oils as indicators of cholesterol absorption and synthesis. These analysis will be conducted by gas chromatography'}, {'measure': 'Proprotein convertase subtilisin/kexin type 9 (PCSK9)', 'timeFrame': '6 weeks', 'description': 'PCSK9 will be measured as a surrogate marker of bile acid synthesis via Ultra Performance Liquid Chromatography-MS/MS'}, {'measure': 'Endothelial function', 'timeFrame': '6 weeks', 'description': 'Assessment of arterial wall resistance and arterial elasticity after consumption of treatment oils It will be assessed using flow mediated dilation'}, {'measure': 'Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids', 'timeFrame': '6 weeks', 'description': 'Heavy water enrichment of each fatty acid methyl ester after consumption of treatment oils will be measured using a gas chromatography with combustion isotope-ratio mass spectrometry'}, {'measure': 'Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism', 'timeFrame': '6 weeks', 'description': "Assessment of the potential influence of each SNP in an individual's response to consumption of treatment oils will be conducted using 7500 Fast Real-Time PCR System"}, {'measure': 'Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism', 'timeFrame': '6 weeks', 'description': 'Assessment of levels of gene expression after consumption of treatment oils will be measured using real-time quantitative PCR'}, {'measure': 'Activity Monitoring', 'timeFrame': '6 weeks', 'description': 'Assessment of 24 hour physical activity including steps taken, raw acceleration, activity counts, energy expenditures, physical activity intensity, body position, and sleep/wake measurements after consumption of treatment oils will be measured using ActiGraph GT3X+ activity monitor'}, {'measure': 'Lipocalin-2', 'timeFrame': '6 weeks', 'description': 'Fecal and serum lipocalin-2 will be analyzed for subgroup of participants using ELISA kit'}, {'measure': 'Lipopolysaccharide (LPS)', 'timeFrame': '6 weeks', 'description': 'Serum LPS will be analyzed for subgroup of participants using the LAL assay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Disease', 'Diabetes', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '31291447', 'type': 'DERIVED', 'citation': 'Hammad SS, Eck P, Sihag J, Chen X, Connelly PW, Lamarche B, Couture P, Guay V, Maltais-Giguere J, West SG, Kris-Etherton PM, Bowen KJ, Jenkins DJA, Taylor CG, Perera D, Wilson A, Castillo S, Zahradka P, Jones PJH. Common Variants in Lipid Metabolism-Related Genes Associate with Fat Mass Changes in Response to Dietary Monounsaturated Fatty Acids in Adults with Abdominal Obesity. J Nutr. 2019 Oct 1;149(10):1749-1756. doi: 10.1093/jn/nxz136.'}, {'pmid': '30773586', 'type': 'DERIVED', 'citation': 'Bowen KJ, Kris-Etherton PM, West SG, Fleming JA, Connelly PW, Lamarche B, Couture P, Jenkins DJA, Taylor CG, Zahradka P, Hammad SS, Sihag J, Chen X, Guay V, Maltais-Giguere J, Perera D, Wilson A, Juan SCS, Rempel J, Jones PJH. Diets Enriched with Conventional or High-Oleic Acid Canola Oils Lower Atherogenic Lipids and Lipoproteins Compared to a Diet with a Western Fatty Acid Profile in Adults with Central Adiposity. J Nutr. 2019 Mar 1;149(3):471-478. doi: 10.1093/jn/nxy307.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of the study are to examine the health benefits of dietary canola oils on body composition, specifically on android fat, and weight management. COMIT II will also include analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body composition. Measurement of endothelial function, inflammatory, adiposity, and insulin sensitivity biomarkers will be done to determine the positive health impact of the changes in body composition achieved through canola oil consumption.', 'detailedDescription': 'The proposed multi-center clinical trial would engage the same collaborative team that successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the L\'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St. Michael\'s Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg, Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research program will proceed as a double blind, randomized crossover study consisting of three treatment phases of six weeks, each separated by a 6-week washout period. Participants will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical "Western diet" fat intake as a control treatment comprised largely of saturated fat with substantial levels of omega-6 linoleic acid, common to current North American intakes. Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and consumed at breakfast and supper. The clinical segment of COMIT II is expected to be completed by the mid to end of the second year, with sample analyses to be completed by the end of year three.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Waist circumference ≥94 cm for men and ≥80 cm for women\n\nParticipants must meet at least one of the following secondary inclusion criteria:\n\n* Fasting blood glucose of ≥ 5.6 mmol/L\n* Triglycerides (TG) ≥1.7 mmol/L\n* HDL cholesterol (HDL) \\<1 mmol/L (males) or \\<1.3 mmol/L (females)\n* Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic).\n\nExclusion Criteria:\n\n* Kidney, or liver disease, or unstable thyroid disease\n* Diabetes mellitus\n* Smokers\n* Those consuming \\>1 alcoholic beverage a day for women and \\>2 for men.\n* Any participant taking medication known to affect lipid metabolism or endothelial function'}, 'identificationModule': {'nctId': 'NCT02029833', 'acronym': 'COMIT2', 'briefTitle': 'Canola Oil Multi-Centre Intervention Trial II', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'B2013:137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regular Canola Oil', 'description': '60% oleic acid', 'interventionNames': ['Other: Regular Canola Oil']}, {'type': 'EXPERIMENTAL', 'label': 'High Oleic Canola Oil', 'description': '70% oleic acid', 'interventionNames': ['Other: High Oleic Canola Oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Western Type Diet - Common Dietary Oils', 'description': 'Ghee, Safflower oil, Coconut oil, \\& flax oil', 'interventionNames': ['Other: Western Type Diet - Common Dietary Oils']}], 'interventions': [{'name': 'Regular Canola Oil', 'type': 'OTHER', 'armGroupLabels': ['Regular Canola Oil']}, {'name': 'High Oleic Canola Oil', 'type': 'OTHER', 'armGroupLabels': ['High Oleic Canola Oil']}, {'name': 'Western Type Diet - Common Dietary Oils', 'type': 'OTHER', 'armGroupLabels': ['Western Type Diet - Common Dietary Oils']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Pennsylvania State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}, {'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'St Boniface Hospital Research', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'R3T 6C5', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'G1V 0A6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institute of Nutrition and Functional Foods, Laval University', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Peter Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Penn State University', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'Laval University', 'class': 'OTHER'}, {'name': 'St. Boniface Hospital', 'class': 'OTHER'}, {'name': 'University at Buffalo', 'class': 'OTHER'}, {'name': 'Canola Council of Canada', 'class': 'OTHER'}, {'name': 'Agriculture and Agri-Food Canada', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}