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Completed

NCT Number: NCT03054779

Canola Oil Multi-center Intervention Trial II

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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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canola Oil

Other

Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.

High oleic acid canola oil

Other

High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.

Western diet oil combination

Other

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

Primary outcomes

  1. Body composition

    Time frame: 1 year 6 months

    Will be measured using DXA

  2. Plasma lipids

    Time frame: 1 year 6 months

  3. Flow mediated dilation (FMD) for endothelial function

    Time frame: 1 year 6 months

  4. Lipoprotein subclasses

    Time frame: 1 year 6 months

  5. Inflammatory markers

    Time frame: 1 year 6 months

  6. Lipid Peroxidation

    Time frame: 1 year 6 months

Secondary outcomes

  1. Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers

    Time frame: 1 year 6 months

  2. 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

  3. Physical activity level

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Canola Council of Canada
  • Laval University
  • St. Boniface Hospital
  • Unity Health Toronto
  • University of Manitoba

Registry information

Official study 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

Acronym: COMITII

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2017
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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