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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Diabetes; Metabolic Syndrome
• Intervention / Treatment: Other: Regular Canola Oil; Other: High Oleic Canola Oil; Other: Western Type Diet - Common Dietary Oils

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 6C5
      • Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St Boniface Hospital Research
  • Quebec
    • Quebec City, Quebec, Canada, G1V 0A6
      • Institute of nutrition and functional foods, Laval University
• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regular Canola Oil; 60% oleic acid	Other: Regular Canola Oil
Experimental: High Oleic Canola Oil; 70% oleic acid	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of fatty acid ethanolamides and precursors	Analysis of FAEs in the blood after consumption of treatment oils. UPLC-MS/MS will be used for FAE measurement.	6 weeks
Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels	Analysis of blood levels after consumption of treatment oils. Abbott Spectrum CCX Analyzer utilizing enzymatic reagents will be used to analyzed these measurements.	6 weeks
Plasma insulin level	Assessment of the change in insulin levels after consumption of treatment oils. This measurement will be analyzed by commercially available ELISA kits	6 weeks
Plasma glucose level	Assessment of changes in fasting glucose levels after consumption of treatment oils. This measurement will be analyzed by Abbott Spectrum CCX Analyzer	6 weeks
Plasma C-reactive protein level	Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits	6 weeks
Plasma cytokines level	Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits	6 weeks
Plant sterols and precursors of cholesterol	Analysis of plasma levels after consumption of treatment oils as indicators of cholesterol absorption and synthesis. These analysis will be conducted by gas chromatography	6 weeks
Proprotein convertase subtilisin/kexin type 9 (PCSK9)	PCSK9 will be measured as a surrogate marker of bile acid synthesis via Ultra Performance Liquid Chromatography-MS/MS	6 weeks
Endothelial function	Assessment of arterial wall resistance and arterial elasticity after consumption of treatment oils It will be assessed using flow mediated dilation	6 weeks
Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids	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	6 weeks
Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism	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	6 weeks
Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism	Assessment of levels of gene expression after consumption of treatment oils will be measured using real-time quantitative PCR	6 weeks
Activity Monitoring	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	6 weeks
Lipocalin-2	Fecal and serum lipocalin-2 will be analyzed for subgroup of participants using ELISA kit	6 weeks
Lipopolysaccharide (LPS)	Serum LPS will be analyzed for subgroup of participants using the LAL assay	6 weeks

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: University of Toronto; University at Buffalo; Penn State University; Agriculture and Agri-Food Canada; Laval University; Canola Council of Canada; St. Boniface Hospital
• Investigators: Principal Investigator: Peter Jones, PhD, University of Manitoba

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: B2013:137