Canola Oil Multi-Centre Intervention Trial II (COMIT2)
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ClinicalTrials.gov Identifier: NCT02029833 |
Recruitment Status :
Completed
First Posted : January 8, 2014
Last Update Posted : March 17, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease Diabetes Metabolic Syndrome | Other: Regular Canola Oil Other: High Oleic Canola Oil Other: Western Type Diet - Common Dietary Oils | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | November 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Regular Canola Oil
60% oleic acid
|
Other: Regular Canola Oil |
Experimental: High Oleic Canola Oil
70% oleic acid
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Other: High Oleic Canola Oil |
Active Comparator: Western Type Diet - Common Dietary Oils
Ghee, Safflower oil, Coconut oil, & flax oil
|
Other: Western Type Diet - Common Dietary Oils |
- Abdominal imaging of visceral and subcutaneous abdominal fat [ Time Frame: 6 weeks ]Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.
- Analysis of fatty acid ethanolamides and precursors [ Time Frame: 6 weeks ]Analysis of FAEs in the blood after consumption of treatment oils. UPLC-MS/MS will be used for FAE measurement.
- Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels [ Time Frame: 6 weeks ]Analysis of blood levels after consumption of treatment oils. Abbott Spectrum CCX Analyzer utilizing enzymatic reagents will be used to analyzed these measurements.
- Plasma insulin level [ Time Frame: 6 weeks ]Assessment of the change in insulin levels after consumption of treatment oils. This measurement will be analyzed by commercially available ELISA kits
- Plasma glucose level [ Time Frame: 6 weeks ]Assessment of changes in fasting glucose levels after consumption of treatment oils. This measurement will be analyzed by Abbott Spectrum CCX Analyzer
- Plasma C-reactive protein level [ Time Frame: 6 weeks ]Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits
- Plasma cytokines level [ Time Frame: 6 weeks ]Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits
- Plant sterols and precursors of cholesterol [ Time Frame: 6 weeks ]Analysis of plasma levels after consumption of treatment oils as indicators of cholesterol absorption and synthesis. These analysis will be conducted by gas chromatography
- Proprotein convertase subtilisin/kexin type 9 (PCSK9) [ Time Frame: 6 weeks ]PCSK9 will be measured as a surrogate marker of bile acid synthesis via Ultra Performance Liquid Chromatography-MS/MS
- Endothelial function [ Time Frame: 6 weeks ]Assessment of arterial wall resistance and arterial elasticity after consumption of treatment oils It will be assessed using flow mediated dilation
- Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids [ Time Frame: 6 weeks ]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
- Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism [ Time Frame: 6 weeks ]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
- Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism [ Time Frame: 6 weeks ]Assessment of levels of gene expression after consumption of treatment oils will be measured using real-time quantitative PCR
- Activity Monitoring [ Time Frame: 6 weeks ]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
- Lipocalin-2 [ Time Frame: 6 weeks ]Fecal and serum lipocalin-2 will be analyzed for subgroup of participants using ELISA kit
- Lipopolysaccharide (LPS) [ Time Frame: 6 weeks ]Serum LPS will be analyzed for subgroup of participants using the LAL assay

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Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Waist circumference ≥94 cm for men and ≥80 cm for women
Participants must meet at least one of the following secondary inclusion criteria:
- Fasting blood glucose of ≥ 5.6 mmol/L
- Triglycerides (TG) ≥1.7 mmol/L
- HDL cholesterol (HDL) <1 mmol/L (males) or <1.3 mmol/L (females)
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic).
Exclusion Criteria:
- Kidney, or liver disease, or unstable thyroid disease
- Diabetes mellitus
- Smokers
- Those consuming >1 alcoholic beverage a day for women and >2 for men.
- Any participant taking medication known to affect lipid metabolism or endothelial function

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029833
United States, Pennsylvania | |
The Pennsylvania State University | |
University Park, Pennsylvania, United States, 16802 | |
Canada, Manitoba | |
St Boniface Hospital Research | |
Winnipeg, Manitoba, Canada, R2H 2A6 | |
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba | |
Winnipeg, Manitoba, Canada, R3T 6C5 | |
Canada, Quebec | |
Institute of Nutrition and Functional Foods, Laval University | |
Quebec City, Quebec, Canada, G1V 0A6 |
Principal Investigator: | Peter Jones, PhD | University of Manitoba |
Responsible Party: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT02029833 |
Other Study ID Numbers: |
B2013:137 |
First Posted: | January 8, 2014 Key Record Dates |
Last Update Posted: | March 17, 2023 |
Last Verified: | April 2021 |
Cardiovascular Diseases Metabolic Syndrome Syndrome Disease Pathologic Processes |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |