Clinical trial NCT03054779: Canola Oil Multi-center Intervention Trial II
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Metabolic Syndrome
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Canola Council of Canada
name: University of Manitoba
name: Laval University
name: Unity Health Toronto
name: St. Boniface Hospital
First posted: 2017-02-16
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body composition
timeFrame: 1 year 6 months
measure: Plasma lipids
timeFrame: 1 year 6 months
measure: Flow mediated dilation (FMD) for endothelial function
timeFrame: 1 year 6 months
measure: Lipoprotein subclasses
timeFrame: 1 year 6 months
measure: Inflammatory markers
timeFrame: 1 year 6 months
measure: Lipid Peroxidation
timeFrame: 1 year 6 months
Secondary outcomes:
measure: Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers
timeFrame: 1 year 6 months
measure: Genetic analysis to evaluate the association between FADS 1 and FADS 2 mRNA and protein expression in peripheral blood mononuclear blood cells (PBMCs)
timeFrame: 1 year 6 months
measure: Physical activity level
timeFrame: 1 year 6 months
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References: