Canola Oil Multi-Centre Intervention Trial II (COMIT2)

• ClinicalTrials.gov Identifier: NCT02029833
• Recruitment Status: Completed
• First Posted: January 8, 2014
• Last Update Posted: May 24, 2019
• Sponsor: University of Manitoba
• Collaborators: Penn State University; University of Toronto; Laval University; St. Boniface Hospital; University at Buffalo; Canola Council of Canada; Dow AgroSciences; Agriculture and Agri-Food Canada
• Information provided by (Responsible Party): University of Manitoba

Tracking Information

• First Submitted Date: December 9, 2013
• First Posted Date: January 8, 2014
• Last Update Posted Date: May 24, 2019
• Study Start Date: March 2013
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 1, 2015)

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.

Original Primary Outcome Measures (submitted: January 6, 2014)

Abdominal imaging of visceral and subcutaneous abdominal fat [ Time Frame: Up to three years ]

Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.

Current Secondary Outcome Measures (submitted: March 1, 2017)

• 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

Original Secondary Outcome Measures (submitted: January 6, 2014)

Analysis of fatty acid ethanolamides and precursors [ Time Frame: Up to three years ]

Analysis of FAEs in the blood after consumption of treatment oils. UPLC-MS/MS will be used for FAE measurement.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Canola Oil Multi-Centre Intervention Trial II
• Official Title: Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Cardiovascular Disease
• Diabetes
• Metabolic Syndrome

Intervention

• Other: Regular Canola Oil
• Other: High Oleic Canola Oil
• Other: Western Type Diet - Common Dietary Oils

Study Arms

• Experimental: Regular Canola Oil
  60% oleic acid
  Intervention: Other: Regular Canola Oil
• Experimental: High Oleic Canola Oil
  70% oleic acid
  Intervention: Other: High Oleic Canola Oil
• Active Comparator: Western Type Diet - Common Dietary Oils
  Ghee, Safflower oil, Coconut oil, & flax oil
  Intervention: Other: Western Type Diet - Common Dietary Oils

Publications *

• Hammad SS, Eck P, Sihag J, Chen X, Connelly PW, Lamarche B, Couture P, Guay V, Maltais-Giguère 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-Giguère 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2016): 125
• Original Estimated Enrollment (submitted: January 6, 2014): 140
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT02029833
• Other Study ID Numbers: B2013:137
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Manitoba
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Manitoba
• Original Study Sponsor: Same as current

Collaborators

• Penn State University
• University of Toronto
• Laval University
• St. Boniface Hospital
• University at Buffalo
• Canola Council of Canada
• Dow AgroSciences
• Agriculture and Agri-Food Canada

Investigators

• Principal Investigator: Peter Jones, PhD; University of Manitoba

• PRS Account: University of Manitoba
• Verification Date: May 2019