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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 : May 24, 2019
Sponsor:
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  ICMJE December 9, 2013
First Posted Date  ICMJE January 8, 2014
Last Update Posted Date May 24, 2019
Study Start Date  ICMJE March 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Canola Oil Multi-Centre Intervention Trial II
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Diabetes
  • Metabolic Syndrome
Intervention  ICMJE
  • Other: Regular Canola Oil
  • Other: High Oleic Canola Oil
  • Other: Western Type Diet - Common Dietary Oils
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2016)
125
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2014)
140
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02029833
Other Study ID Numbers  ICMJE B2013:137
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Peter Jones, PhD University of Manitoba
PRS Account University of Manitoba
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP