Completed

COMIT2Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Regular Canola Oil

+ High Oleic Canola Oil

+ Western Type Diet - Common Dietary Oils

Other
Who is being recruted

Cardiovascular Diseases+6

+ Diabetes Mellitus

+ Endocrine System Diseases

From 20 to 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Manitoba
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleEffects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome
NCT02029833
Principal SponsorUniversity of Manitoba
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

125 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusEndocrine System DiseasesHyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesMetabolic SyndromeGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate
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).

5 exclusion criteria prevent from participating
Kidney, or liver disease, or unstable thyroid disease

Diabetes mellitus

Smokers

Those consuming >1 alcoholic beverage a day for women and >2 for men.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
60% oleic acid

Group II

Experimental
70% oleic acid

Group III

Active Comparator
Ghee, Safflower oil, Coconut oil, \& flax oil

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

The Pennsylvania State University

University Park, United StatesOpen The Pennsylvania State University in Google Maps
Suspended

St Boniface Hospital Research

Winnipeg, Canada
Suspended

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Canada
Suspended

Institute of Nutrition and Functional Foods, Laval University

Québec, Canada
Completed4 Study Centers
COMIT2 | Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome | PatLynk