Canola Oil Multi-Centre Intervention Trial II (COMIT2)

University of Manitoba

Status: Completed

Conditions: Diabetes; Metabolic Syndrome; Cardiovascular Disease

Treatments: Other: Western Type Diet - Common Dietary Oils; Other: High Oleic Canola Oil; Other: Regular Canola Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02029833

B2013:137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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125 participants in 3 patient groups

Regular Canola Oil

Experimental group

Description:

60% oleic acid

Treatment:

Other: Regular Canola Oil

High Oleic Canola Oil

Experimental group

Description:

70% oleic acid

Treatment:

Other: High Oleic Canola Oil

Western Type Diet - Common Dietary Oils

Active Comparator group

Description:

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

Treatment:

Other: Western Type Diet - Common Dietary Oils