Canola Oil Multi-Centre Intervention Trial II

N/ACompletedNCT02029833

University of Manitoba125 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Conditions

Cardiovascular Disease Diabetes Metabolic Syndrome

Interventions

Regular Canola OilOTHER

High Oleic Canola OilOTHER

Western Type Diet - Common Dietary OilsOTHER

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

The Pennsylvania State University

University Park, Pennsylvania, United States

St Boniface Hospital Research

Winnipeg, Manitoba, Canada

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, Canada

Institute of Nutrition and Functional Foods, Laval University

Québec, Quebec, Canada

Outcomes

Primary Outcomes

Abdominal imaging of visceral and subcutaneous abdominal fat

Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.

Time frame: 6 weeks

Secondary Outcomes

Analysis of fatty acid ethanolamides and precursors

Analysis of FAEs in the blood after consumption of treatment oils. UPLC-MS/MS will be used for FAE measurement.

Time frame: 6 weeks

Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels

Analysis of blood levels after consumption of treatment oils. Abbott Spectrum CCX Analyzer utilizing enzymatic reagents will be used to analyzed these measurements.

Time frame: 6 weeks

Plasma insulin level

Assessment of the change in insulin levels after consumption of treatment oils. This measurement will be analyzed by commercially available ELISA kits

Time frame: 6 weeks

Plasma glucose level

Assessment of changes in fasting glucose levels after consumption of treatment oils. This measurement will be analyzed by Abbott Spectrum CCX Analyzer

Time frame: 6 weeks

Plasma C-reactive protein level

Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits

Time frame: 6 weeks

Plasma cytokines level

Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits

Data from ClinicalTrials.gov

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