Canola Oil Multicentre Intervention Trial (COMIT)
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|ClinicalTrials.gov Identifier: NCT01351012|
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : February 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Other: Corn and safflower oil Other: Canola oil Other: High oleic acid canola oil Other: DHA enriched high oleic acid canola oil Other: Flax and safflower oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||April 2012|
|Placebo Comparator: Corn and safflower oil||
Other: Corn and safflower oil
The oil (60 g/d/3000 kcal) is given in two daily fruit shakes for 4 weeks
|Active Comparator: Canola oil||
Other: Canola oil
The oil (60 g/d/3000 kcal providing 3.8 g ALA) is given in two daily fruit shakes for 4 weeks
|Active Comparator: High oleic acid canola oil||
Other: High oleic acid canola oil
The oil (60 g/d/3000 kcal providing 41.2 g oleic acid and 1.2 g ALA) is given in two daily fruit shakes for 4 weeks
|Active Comparator: DHA enriched high oleic acid canola oil||
Other: DHA enriched high oleic acid canola oil
The oil (60 g/d/3000 kcal providing 1.2 g of ALA and 3.6 g of DHA) is given in two daily fruit shakes for 4 weeks
|Active Comparator: Flax and safflower oil||
Other: Flax and safflower oil
The oil (60 g/d/3000 kcal providing 6.9 g of ALA) is given in two daily fruit shakes for 4 weeks
- Change in endothelial function [ Time Frame: Endothelial function will be measured at baseline and at the end of each of the five 4-week treatment phases over a period of nine months. ]Non-invasive peripheral arterial tonometry (EndoPAT) is used to assess endothelial function.
- Change in ALA conversion to EPA/DHA [ Time Frame: Blood samples will be collected at the end of each of the five 4-week treatment phases over a period of nine months. ]On day 28 of each experimental phase, a fasting baseline blood sample is taken prior to administration of an oral dose of deuterium oxide containing a higher than normal proportion of the hydrogen isotope deuterium (2H). Fasting blood samples will be obtained 24 h following the tracer dose. Enrichment of 2H in EPA and DHA plasma triglycerides, non-esterified fatty acids, and phosphatidylcholine will be measured by GC-combustion isotope-ratio mass spectrometry.
- Change in body composition [ Time Frame: Measurements will be done at the start and end of each of the five 4-week treatment phases over a period of nine months. ]Changes in body composition will be assessed using dual-energy X-ray absorptiometry (DXA) scans. Also, a MRI scan will be performed on each subject at the start of the study.
- Change in FADS 1 & 2 mRNA and protein expression [ Time Frame: Blood samples will be collected at the end of each of the five 4-week treatment phases over a nine-month period. ]mRNA and protein expression of genes/proteins involved in fatty acid metabolism will be analyzed using standard RT-PCR and immunoblotting protocols.
- Change in psychosocial correlates [ Time Frame: Measurements are done at baseline, at the start of the fifth treatment phase and at the end of each of the five 4-week treatment phases. ]Subjects will complete questionnaires regarding their mood and recent sleep (state questionnaires) and a questionnaire regarding their overall mood, social support and behaviors (trait questionnaire).
- Change in plasma lipids and lipoproteins, inflammatory cytokines and peroxidation biomarkers [ Time Frame: Blood samples are collected at the start and end of each of the five 4-week treatment phases over a nine-month period. ]
- Blood Pressure [ Time Frame: Over 3 years; at baseline and endpoint of each 4-week treatment phases ]Blood pressure data (change in both systolic and diastolic) was taken 3 times at the baseline and endpoint of each phase of the trial. 2nd and 3rd measures were averaged.
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): NCT01351012
|Richardson Centre for Functional Foods and Nutraceuticals|
|Winnipeg, Manitoba, Canada, R3T 2N2|
|Study Chair:||Peter JH Jones, PhD||University of Manitoba|
|Principal Investigator:||David Jenkins, PhD||University of Toronto|
|Principal Investigator:||Penny Kris-Etherton, PhD, RD||Penn State University|
|Principal Investigator:||Sheila West, PhD||Penn State University|
|Principal Investigator:||Benoit Lamarche, PhD||Laval University|