Canola Oil Multi-center Intervention Trial II
COMITII
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedAugust 21, 2023
August 1, 2023
2.2 years
April 28, 2015
August 16, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (3)
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
1 year 6 months
Study Arms (3)
Canola oil
EXPERIMENTALregular canola oil
High oleic acid canola oil
EXPERIMENTALhigh stability/high oleic canola oil
Western diet oil combination
ACTIVE COMPARATORa 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
Interventions
Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
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
Eligibility Criteria
You may qualify if:
- 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 \[Unmedicated participants - upper limit of Stage 1 Hypertension: systolic \< 160 and/or diastolic \<100 mm HG and participants must be free of end stage/target organ disease symptoms\] \[BP medicated participants: acceptable as long as individuals meet the specified blood pressure range of \<140/90 mmHg, and have been stable for at least 6 months\]
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penn State Universitylead
- Canola Council of Canadacollaborator
- University of Manitobacollaborator
- Laval Universitycollaborator
- Unity Health Torontocollaborator
- St. Boniface Hospitalcollaborator
Study Sites (1)
Penn State University
University Park, Pennsylvania, 16802, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penny M Kris-Etherton, PhD
Penn State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
February 16, 2017
Study Start
September 1, 2014
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
August 21, 2023
Record last verified: 2023-08