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Canola Oil Multi-center Intervention Trial II (COMITII)

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ClinicalTrials.gov Identifier: NCT03054779
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Collaborators:
Canola Council of Canada
University of Manitoba
Laval University
St. Michael's Hospital, Toronto
St. Boniface General Hospital Research Centre
Information provided by (Responsible Party):
Penny Kris-Etherton, 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Metabolic Syndrome Other: Canola Oil Other: High oleic acid canola oil Other: Western diet oil combination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : September 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054779


Locations
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United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Canola Council of Canada
University of Manitoba
Laval University
St. Michael's Hospital, Toronto
St. Boniface General Hospital Research Centre
Investigators
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Principal Investigator: Penny M Kris-Etherton, PhD Penn State University

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Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT03054779     History of Changes
Other Study ID Numbers: PKE COMIT II
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Cardiovascular Diseases
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases