Canola Oil Multicentre Intervention Trial (COMIT)

This study has been completed.
Sponsor:
Collaborators:
University of Toronto
Penn State University
Laval University
Information provided by (Responsible Party):
Dr. Peter Jones, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01351012
First received: March 14, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to examine how the consumption of different dietary oil varieties affects a broad range of metabolic responses that are important in the development of cardiovascular diseases. This study will examine the relationship between dietary oil consumption and arterial function, blood fat content, and blood markers of cardiovascular disease risk. Additionally, the efficiency of the body in converting fat from dietary oils into other specific fat compounds with know health benefits will be examined. Also, the correlation between psychosocial parameters and vascular function will be studied.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Non-invasive peripheral arterial tonometry (EndoPAT) is used to assess endothelial function.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: Over 3 years; at baseline and endpoint of each 4-week treatment phases ] [ Designated as safety issue: No ]
    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.


Enrollment: 140
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Although consumption of omega-3 fatty acids favorably modulate circulating lipids and arterial health, there is confusion surrounding the specific health benefits of plant based alpha-linolenic acid (ALA) versus marine derived eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This research will examine the health benefits of ALA from consumption of diets rich in canola oil, novel monounsaturated fatty acid (MUFA) and DHA enriched canola oils, and flax oil compared with a control diet representative of North American diets rich in omega-6 and saturated fats. Treatment oils will be examined for potential influence on endothelial dysfunction, inflammation, oxidation, body composition, and plasma lipoprotein characterization. Furthermore, in an effort to elucidate the genetic factors that promote ALA conversion to EPA/DHA and strengthen the role of ALA in cardiovascular health, a major objective is to correlate common genetic variants in the fatty acid desaturase 1 (FADS1) and fatty acid desaturase 2 (FADS2) gene cluster with ALA conversion to EPA/DHA and n-3 fatty acid composition of serum phospholipids in response to consumption of the treatment oils. Besides, psychosocial predictors of vascular function will be investigated.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Waist circumference ≥94 cm (males) or ≥80 cm (females)

plus at least one of the following:

  • Triglycerides ≥1.7 mmol/L
  • High density lipoprotein (HDL) cholesterol <1 mmol/L (males) or <1.3 mmol/L (females)
  • Low density lipoprotein (LDL) cholesterol ≥3.5 mmol/L
  • Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
  • Glucose ≥5.5 mmol/L

Exclusion Criteria:

  • Thyroid disease
  • Diabetes mellitus
  • Kidney disease
  • Liver disease
  • Smoking
  • Heavy drinking
  • Use of medication known to affect lipid metabolism during the last 3 months(cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351012

Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
University of Toronto
Penn State University
Laval University
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Peter Jones, Director of the Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
ClinicalTrials.gov Identifier: NCT01351012     History of Changes
Other Study ID Numbers: B2010:047
Study First Received: March 14, 2011
Last Updated: February 18, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Canola oil
High oleic canola oil
Flax oil
ALA
DHA
Metabolic syndrome
Cardiovascular disease
Endothelial function
FADS1
Gut microbiome
Body composition
Psychosocial status
Cholesterol
Lipids
Lipoproteins
Inflammation
Lipid peroxidation

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

ClinicalTrials.gov processed this record on October 19, 2014