Canola Oil Multi-center Intervention Trial II

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Metabolic Syndrome
• Interventions: Other: Canola Oil; Other: High oleic acid canola oil; Other: Western diet oil combination

• Registration Number: NCT03054779
• Lead Sponsor: Penn State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-04-28
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Canola oil	Canola Oil	regular canola oil
High oleic acid canola oil	High oleic acid canola oil	high stability/high oleic canola oil
Western diet oil combination	Western diet oil combination	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

Primary Outcome Measures

Name	Time	Method
Inflammatory markers	1 year 6 months
Body composition	1 year 6 months	Will be measured using DXA
Plasma lipids	1 year 6 months
Lipid Peroxidation	1 year 6 months
Lipoprotein subclasses	1 year 6 months
Flow mediated dilation (FMD) for endothelial function	1 year 6 months

Secondary Outcome Measures

Name	Time	Method
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
Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers	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

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States