Cardiovascular Disease, Metabolic Syndrome
Conditions
Brief summary
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.
Interventions
OTHERCanola Oil
Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
OTHERWestern diet oil combination
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
Sponsors
Canola Council of Canada
University of Manitoba
Laval University
Unity Health Toronto
St. Boniface Hospital
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Peroxidation | 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 | — |
| Body composition | 1 year 6 months | Will be measured using DXA |
| Plasma lipids | 1 year 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year 6 months | Will be assessed using an Actigraph GT3X+ activity monitor to be worn for 1 week at the end of each treatment period |
| Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers | 1 year 6 months | — |
Countries
United States
Outcome results
None listed