Canola Oil Multi-Centre Intervention Trial II
COMIT2
Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome
1 other identifier
interventional
125
2 countries
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 17, 2023
April 1, 2021
3.7 years
December 9, 2013
March 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Abdominal imaging of visceral and subcutaneous abdominal fat
Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.
6 weeks
Secondary Outcomes (15)
Analysis of fatty acid ethanolamides and precursors
6 weeks
Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels
6 weeks
Plasma insulin level
6 weeks
Plasma glucose level
6 weeks
Plasma C-reactive protein level
6 weeks
- +10 more secondary outcomes
Study Arms (3)
Regular Canola Oil
EXPERIMENTAL60% oleic acid
High Oleic Canola Oil
EXPERIMENTAL70% oleic acid
Western Type Diet - Common Dietary Oils
ACTIVE COMPARATORGhee, Safflower oil, Coconut oil, \& flax oil
Interventions
Eligibility Criteria
You may qualify if:
- \- Waist circumference ≥94 cm for men and ≥80 cm for women
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Penn State Universitycollaborator
- University of Torontocollaborator
- Laval Universitycollaborator
- St. Boniface Hospitalcollaborator
- University at Buffalocollaborator
- Canola Council of Canadacollaborator
- Agriculture and Agri-Food Canadacollaborator
Study Sites (4)
The Pennsylvania State University
University Park, Pennsylvania, 16802, United States
St Boniface Hospital Research
Winnipeg, Manitoba, R2H 2A6, Canada
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5, Canada
Institute of Nutrition and Functional Foods, Laval University
Québec, Quebec, G1V 0A6, Canada
Related Publications (2)
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: 31291447DERIVEDBowen 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.
PMID: 30773586DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Jones, PhD
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2013
First Posted
January 8, 2014
Study Start
March 1, 2013
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
March 17, 2023
Record last verified: 2021-04