Canola Oil Multi-center Intervention Trial II (COMITII)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Metabolic Syndrome
• Intervention / Treatment: Other: Canola Oil; Other: High oleic acid canola oil; Other: Western diet oil combination

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canola oil; regular canola oil	Other: Canola Oil; Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
Experimental: High oleic acid canola oil; high stability/high oleic canola oil	Other: High oleic acid canola oil; High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
Active Comparator: 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	Other: Western 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: University of Manitoba; Unity Health Toronto; Laval University; Canola Council of Canada; St. Boniface Hospital
• Investigators: Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: PKE COMIT II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No