An interventional study of Canola Oil and High oleic acid canola oil in Cardiovascular Disease and Metabolic Syndrome, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
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.
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Exclusion Criteria:
regular canola oil
Other: Canola Oil
high stability/high oleic canola oil
Other: High oleic acid canola oil
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
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.
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
Body composition
Will be measured using DXA
Time frame: 1 year 6 months
Plasma lipids
Time frame: 1 year 6 months
Flow mediated dilation (FMD) for endothelial function
Time frame: 1 year 6 months
Lipoprotein subclasses
Time frame: 1 year 6 months
Inflammatory markers
Time frame: 1 year 6 months
Lipid Peroxidation
Time frame: 1 year 6 months
Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers
Time frame: 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)
Time frame: 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
Time frame: 1 year 6 months
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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