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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 : July 20, 2018
Sponsor:
Collaborators:
Penn State University
University of Toronto
Laval University
St. Boniface General Hospital Research Centre
University at Buffalo
Canola Council of Canada
Dow AgroSciences
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
University of Manitoba

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.

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

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  (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
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. Plasma cytokines level [ Time Frame: 6 weeks ]
    Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Lipocalin-2 [ Time Frame: 6 weeks ]
    Fecal and serum lipocalin-2 will be analyzed for subgroup of participants using ELISA kit

  15. 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
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

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
University of Manitoba
Penn State University
University of Toronto
Laval University
St. Boniface General Hospital Research Centre
University at Buffalo
Canola Council of Canada
Dow AgroSciences
Agriculture and Agri-Food Canada
Investigators
Principal Investigator: Peter Jones, PhD University of Manitoba

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02029833     History of Changes
Other Study ID Numbers: B2013:137
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Syndrome
Cardiovascular Diseases
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases