Canola Oil Multi-center Intervention Trial II

Study Overview
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Brief Summary
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Building on the findings from the investigators previous study, COMIT I, the purpose of the COMIT II study is to supplement the DEXA measurement of body composition with a supplementary DEXA measurement of visceral adipose tissue and to specifically target the impact of oleic acid consumption on body composition as the primary objective. COMIT II also will include analysis of fatty acid ethanolamines (FAEs) and their precursors to elucidate the mechanisms by which canola oil may be modifying body composition, measurement of endothelial function, inflammatory, adiposity and insulin sensitivity biomarkers, and genetic analyses.

Official Title
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Canola Oil Multi-center Intervention Trial II (COMIT II): Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome Risk Factors

Conditions
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Cardiovascular Disease, Metabolic Syndrome

Intervention / Treatment
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* Other: Canola Oil
* Other: High oleic acid canola oil
* Other: Western diet oil combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: waist circumference ≥94 cm for men and ≥80 cm for women Elevated triglycerides - ≥150 mg/dL and ≤ 400 mg/dL Reduced HDL - < 40 mg/dL for men and < 50 mg/dL for women Fasting glucose - ≥ 100 mg/dl and ≤ 126 mg/dL Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG [Unmedicated participants - upper limit of Stage 1 Hypertension: systolic < 160 and/or diastolic <100 mm HG and participants must be free of end stage/target organ disease symptoms] [BP medicated participants: acceptable as long as individuals meet the specified blood pressure range of <140/90 mmHg, and have been stable for at least 6 months] Exclusion Criteria: Individuals with thyroid**, kidney, or liver disease [Individuals with thyroid disease whose blood values are within normal limits and that have been stable (on medication) for the past 6 months are considered eligible] Individuals with diabetes mellitus Smokers Individuals consuming >14 alcoholic beverages per week Individuals taking lipid lowering medication (ex: cholestyramine, colestipol, niacin, cloribrate, gemfibrozil, probucol, HMG CoA reductase inhibitors) for at least the last 3 months Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canola oil<br>regular canola oil | Other: Canola Oil<br>* Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.<br>|
| Experimental: High oleic acid canola oil<br>high stability/high oleic canola oil | Other: High oleic acid canola oil<br>* High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.<br>|
| Active Comparator: Western diet oil combination<br>a typical Western diet fat intake comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA | Other: Western diet oil combination<br>* A typical Western diet fat intake as a control treatment, comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA, will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Will be measured using DXA | 1 year 6 months | 
| Plasma lipids |  | 1 year 6 months | 
| Flow mediated dilation (FMD) for endothelial function |  | 1 year 6 months | 
| Lipoprotein subclasses |  | 1 year 6 months | 
| Inflammatory markers |  | 1 year 6 months | 
| Lipid Peroxidation |  | 1 year 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers |  | 1 year 6 months | 
| Genetic analysis to evaluate the association between FADS 1 and FADS 2 mRNA and protein expression in peripheral blood mononuclear blood cells (PBMCs) |  | 1 year 6 months | 
| Physical activity level | Will be assessed using an Actigraph GT3X+ activity monitor to be worn for 1 week at the end of each treatment period | 1 year 6 months |