Cardiovascular DiseaseCOMITIINCT03054779
Canola Oil Multi-center Intervention Trial II
A study testing Canola Oil, High oleic acid canola oil and Western diet oil combination in people with Cardiovascular Disease and Metabolic Syndrome, run by Penn State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Metabolic Syndrome
- What is being tested?
- Canola Oil, High oleic acid canola oil and Western diet oil combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
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
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.
- Conditions
- Cardiovascular Disease, Metabolic Syndrome
- Being tested
- Canola Oil, High oleic acid canola oil, Western diet oil combination
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canola OilOther
Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
High oleic acid canola oilOther
High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
Western diet oil combinationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Canola oil | Experimental | regular canola oil Receives: Other: Canola Oil |
| High oleic acid canola oil | Experimental | high stability/high oleic canola oil Receives: Other: High oleic acid canola oil |
| Western diet oil combination | Active comparator | 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 Receives: Other: Western diet oil combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Will be measured using DXA
Measured: 1 year 6 months
Plasma lipids
Measured: 1 year 6 months
Flow mediated dilation (FMD) for endothelial function
Measured: 1 year 6 months
Lipoprotein subclasses
Measured: 1 year 6 months
Inflammatory markers
Measured: 1 year 6 months
Lipid Peroxidation
Measured: 1 year 6 months
Secondary outcomes (3)
Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers
Measured: 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)
Measured: 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
Measured: 1 year 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startSep 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Canola Council of Canada, University of Manitoba, Laval University, Unity Health Toronto, St. Boniface Hospital
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054779
- Sponsor's protocol ID
- PKE COMIT II
- Acronym
- COMITII
- Status last verified
- Aug 2023
- First submitted
- 28 Apr 2015
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03054779
- Acronym / sponsor ID
- COMITII / PKE COMIT II
- Conditions
- Cardiovascular Disease, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Canola Council of Canada, University of Manitoba, Laval University, Unity Health Toronto, St. Boniface Hospital
- Study start
- Sep 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Canola oil | Experimental | Other: Canola Oilregular canola oil |
| High oleic acid canola oil | Experimental | Other: High oleic acid canola oilhigh stability/high oleic canola oil |
| Western diet oil combination | Active comparator | Other: Western diet oil combinationa 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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]
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canola OilRegular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily. | Other | Canola oil |
| High oleic acid canola oilHigh oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily. | Other | High oleic acid canola oil |
| Western diet oil combinationA 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 | Other | Western diet oil combination |
Primary outcome
Body composition
Time frame: 1 year 6 months
Will be measured using DXA
Plasma lipids
Time frame: 1 year 6 months
Flow mediated dilation (FMD) for endothelial function
Time frame: 1 year 6 months
Lipoprotein subclasses
Time frame: 1 year 6 months
Inflammatory markers
Time frame: 1 year 6 months
Lipid Peroxidation
Time frame: 1 year 6 months
3 secondary outcomes
Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers
Time frame: 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)
Time frame: 1 year 6 months
Physical activity level
Time frame: 1 year 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny M Kris-Etherton, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canola Oil, High oleic acid canola oil and Western diet oil combination in people with Cardiovascular Disease and Metabolic Syndrome, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 1 year 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.