Cardiovascular DiseaseCOMIT2NCT02029833
Canola Oil Multi-Centre Intervention Trial II
A study testing Regular Canola Oil, High Oleic Canola Oil and Western Type Diet - Common Dietary Oils in people with Cardiovascular Disease and Diabetes, run by University of Manitoba at 4 sites in 2 countries.
Trial summary
The objectives of the study are to examine the health benefits of dietary canola oils on body composition, specifically on android fat, and weight management. COMIT II will also include analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body composition. 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, Diabetes, Metabolic Syndrome
- What is being tested?
- Regular Canola Oil, High Oleic Canola Oil and Western Type Diet - Common Dietary Oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2013to 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
- Participants must meet at least one of the following secondary inclusion criteria:
- Fasting blood glucose of ≥ 5.6 mmol/L
- Triglycerides (TG) ≥1.7 mmol/L
- HDL cholesterol (HDL) <1 mmol/L (males) or <1.3 mmol/L (females)
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic).
Who cannot join
- Kidney, or liver disease, or unstable thyroid disease
- Diabetes mellitus
- Smokers
- Those consuming >1 alcoholic beverage a day for women and >2 for men.
- Any participant taking medication known to affect lipid metabolism or endothelial function
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites
Institute of Nutrition and Functional Foods, Laval University
Québec, Quebec, G1V 0A6
St Boniface Hospital Research
Winnipeg, Manitoba, R2H 2A6
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome
The objectives of the study are to examine the health benefits of dietary canola oils on body composition, specifically on android fat, and weight management. COMIT II will also include analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body composition. Measurement of endothelial function, inflammatory, adiposity, and insulin sensitivity biomarkers will be done to determine the positive health impact of the changes in body composition achieved through canola oil consumption.
Read the detailed description
The proposed multi-center clinical trial would engage the same collaborative team that successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the L'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St. Michael's Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg, Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research program will proceed as a double blind, randomized crossover study consisting of three treatment phases of six weeks, each separated by a 6-week washout period. Participants will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical "Western diet" fat intake as a control treatment comprised largely of saturated fat with substantial levels of omega-6 linoleic acid, common to current North American intakes. Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and consumed at breakfast and supper. The clinical segment of COMIT II is expected to be completed by the mid to end of the second year, with sample analyses to be completed by the end of year three.
- Conditions
- Cardiovascular Disease, Diabetes, Metabolic Syndrome
- Being tested
- Regular Canola Oil, High Oleic Canola Oil, Western Type Diet - Common Dietary Oils
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Canola OilOther
High Oleic Canola OilOther
Western Type Diet - Common Dietary OilsOther
| Study group | Role | What they receive |
|---|---|---|
| Regular Canola Oil | Experimental | 60% oleic acid Receives: Other: Regular Canola Oil |
| High Oleic Canola Oil | Experimental | 70% oleic acid Receives: Other: High Oleic Canola Oil |
| Western Type Diet - Common Dietary Oils | Active comparator | Ghee, Safflower oil, Coconut oil, \& flax oil Receives: Other: Western Type Diet - Common Dietary Oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal imaging of visceral and subcutaneous abdominal fat
Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.
Measured: 6 weeks
Secondary outcomes (15)
Analysis of fatty acid ethanolamides and precursors
Analysis of FAEs in the blood after consumption of treatment oils. UPLC-MS/MS will be used for FAE measurement.
Measured: 6 weeks
Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels
Analysis of blood levels after consumption of treatment oils. Abbott Spectrum CCX Analyzer utilizing enzymatic reagents will be used to analyzed these measurements.
Measured: 6 weeks
Plasma insulin level
Assessment of the change in insulin levels after consumption of treatment oils. This measurement will be analyzed by commercially available ELISA kits
Measured: 6 weeks
Plasma glucose level
Assessment of changes in fasting glucose levels after consumption of treatment oils. This measurement will be analyzed by Abbott Spectrum CCX Analyzer
Measured: 6 weeks
Plasma C-reactive protein level
Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits
Measured: 6 weeks
Plasma cytokines level
Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits
Measured: 6 weeks
Plant sterols and precursors of cholesterol
Analysis of plasma levels after consumption of treatment oils as indicators of cholesterol absorption and synthesis. These analysis will be conducted by gas chromatography
Measured: 6 weeks
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
PCSK9 will be measured as a surrogate marker of bile acid synthesis via Ultra Performance Liquid Chromatography-MS/MS
Measured: 6 weeks
Endothelial function
Assessment of arterial wall resistance and arterial elasticity after consumption of treatment oils It will be assessed using flow mediated dilation
Measured: 6 weeks
Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids
Heavy water enrichment of each fatty acid methyl ester after consumption of treatment oils will be measured using a gas chromatography with combustion isotope-ratio mass spectrometry
Measured: 6 weeks
Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism
Assessment of the potential influence of each SNP in an individual's response to consumption of treatment oils will be conducted using 7500 Fast Real-Time PCR System
Measured: 6 weeks
Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism
Assessment of levels of gene expression after consumption of treatment oils will be measured using real-time quantitative PCR
Measured: 6 weeks
Activity Monitoring
Assessment of 24 hour physical activity including steps taken, raw acceleration, activity counts, energy expenditures, physical activity intensity, body position, and sleep/wake measurements after consumption of treatment oils will be measured using ActiGraph GT3X+ activity monitor
Measured: 6 weeks
Lipocalin-2
Fecal and serum lipocalin-2 will be analyzed for subgroup of participants using ELISA kit
Measured: 6 weeks
Lipopolysaccharide (LPS)
Serum LPS will be analyzed for subgroup of participants using the LAL assay
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, University of Toronto, Laval University, St. Boniface Hospital, University at Buffalo, Canola Council of Canada, Agriculture and Agri-Food Canada
- Responsible party
- Sponsor
- Investigators
- Peter Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029833
- Sponsor's protocol ID
- B2013:137
- Acronym
- COMIT2
- Status last verified
- Apr 2021
- First submitted
- 9 Dec 2013
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Hammad SS, Eck P, Sihag J, Chen X, Connelly PW, Lamarche B, Couture P, Guay V, Maltais-Giguere J, West SG, Kris-Etherton PM, Bowen KJ, Jenkins DJA, Taylor CG, Perera D, Wilson A, Castillo S, Zahradka P, Jones PJH. Common Variants in Lipid Metabolism-Related Genes Associate with Fat Mass Changes in Response to Dietary Monounsaturated Fatty Acids in Adults with Abdominal Obesity. J Nutr. 2019 Oct 1;149(10):1749-1756. doi: 10.1093/jn/nxz136.
PubMed 31291447Bowen KJ, Kris-Etherton PM, West SG, Fleming JA, Connelly PW, Lamarche B, Couture P, Jenkins DJA, Taylor CG, Zahradka P, Hammad SS, Sihag J, Chen X, Guay V, Maltais-Giguere J, Perera D, Wilson A, Juan SCS, Rempel J, Jones PJH. Diets Enriched with Conventional or High-Oleic Acid Canola Oils Lower Atherogenic Lipids and Lipoproteins Compared to a Diet with a Western Fatty Acid Profile in Adults with Central Adiposity. J Nutr. 2019 Mar 1;149(3):471-478. doi: 10.1093/jn/nxy307.
PubMed 30773586
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02029833
- Acronym / sponsor ID
- COMIT2 / B2013:137
- Conditions
- Cardiovascular Disease, Diabetes, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Penn State University, University of Toronto, Laval University, St. Boniface Hospital, University at Buffalo, Canola Council of Canada, Agriculture and Agri-Food Canada
- Study start
- Mar 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Jan 2014 (estimated)
- 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.
The objectives of the study are to examine the health benefits of dietary canola oils on body composition, specifically on android fat, and weight management. COMIT II will also include analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body composition. Measurement of endothelial function, inflammatory, adiposity, and insulin sensitivity biomarkers will be done to determine the positive health impact of the changes in body composition achieved through canola oil consumption.
Detailed description
The proposed multi-center clinical trial would engage the same collaborative team that successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the L'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St. Michael's Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg, Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research program will proceed as a double blind, randomized crossover study consisting of three treatment phases of six weeks, each separated by a 6-week washout period. Participants will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical "Western diet" fat intake as a control treatment comprised largely of saturated fat with substantial levels of omega-6 linoleic acid, common to current North American intakes. Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and consumed at breakfast and supper. The clinical segment of COMIT II is expected to be completed by the mid to end of the second year, with sample analyses to be completed by the end of year three.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular Canola Oil | Experimental | Other: Regular Canola Oil60% oleic acid |
| High Oleic Canola Oil | Experimental | Other: High Oleic Canola Oil70% oleic acid |
| Western Type Diet - Common Dietary Oils | Active comparator | Other: Western Type Diet - Common Dietary OilsGhee, Safflower oil, Coconut oil, \& flax oil |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Waist circumference ≥94 cm for men and ≥80 cm for women
- Fasting blood glucose of ≥ 5.6 mmol/L
- Triglycerides (TG) ≥1.7 mmol/L
- HDL cholesterol (HDL) <1 mmol/L (males) or <1.3 mmol/L (females)
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic).
Key exclusion criteria (5 listed)
- Kidney, or liver disease, or unstable thyroid disease
- Diabetes mellitus
- Smokers
- Those consuming >1 alcoholic beverage a day for women and >2 for men.
- Any participant taking medication known to affect lipid metabolism or endothelial function
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 |
|---|---|---|
| Regular Canola Oil | Other | Regular Canola Oil |
| High Oleic Canola Oil | Other | High Oleic Canola Oil |
| Western Type Diet - Common Dietary Oils | Other | Western Type Diet - Common Dietary Oils |
Primary outcome
Abdominal imaging of visceral and subcutaneous abdominal fat
Time frame: 6 weeks
Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.
15 secondary outcomes
Analysis of fatty acid ethanolamides and precursors
Time frame: 6 weeks
Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels
Time frame: 6 weeks
Plasma insulin level
Time frame: 6 weeks
Plasma glucose level
Time frame: 6 weeks
Plasma C-reactive protein level
Time frame: 6 weeks
Plasma cytokines level
Time frame: 6 weeks
Plant sterols and precursors of cholesterol
Time frame: 6 weeks
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Time frame: 6 weeks
Endothelial function
Time frame: 6 weeks
Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids
Time frame: 6 weeks
Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism
Time frame: 6 weeks
Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism
Time frame: 6 weeks
Activity Monitoring
Time frame: 6 weeks
Lipocalin-2
Time frame: 6 weeks
Lipopolysaccharide (LPS)
Time frame: 6 weeks
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 17 Mar 2023.
- Derived from this study: PubMed 31291447Hammad SS, Eck P, Sihag J, Chen X, Connelly PW, Lamarche B, Couture P, Guay V, Maltais-Giguere J, West SG, Kris-Etherton PM, Bowen KJ, Jenkins DJA, Taylor CG, Perera D, Wilson A, Castillo S, Zahradka P, Jones PJH. Common Variants in Lipid Metabolism-Related Genes Associate with Fat Mass Changes in Response to Dietary Monounsaturated Fatty Acids in Adults with Abdominal Obesity. J Nutr. 2019 Oct 1;149(10):1749-1756. doi: 10.1093/jn/nxz136.
- Derived from this study: PubMed 30773586Bowen KJ, Kris-Etherton PM, West SG, Fleming JA, Connelly PW, Lamarche B, Couture P, Jenkins DJA, Taylor CG, Zahradka P, Hammad SS, Sihag J, Chen X, Guay V, Maltais-Giguere J, Perera D, Wilson A, Juan SCS, Rempel J, Jones PJH. Diets Enriched with Conventional or High-Oleic Acid Canola Oils Lower Atherogenic Lipids and Lipoproteins Compared to a Diet with a Western Fatty Acid Profile in Adults with Central Adiposity. J Nutr. 2019 Mar 1;149(3):471-478. doi: 10.1093/jn/nxy307.
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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.
Peter Jones, PhD principal investigator
University of Manitoba
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Canola Oil, High Oleic Canola Oil and Western Type Diet - Common Dietary Oils in people with Cardiovascular Disease and Diabetes, run by University of Manitoba at 4 sites in 2 countries.
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 6 inclusion and 5 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 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, 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?
Abdominal imaging of visceral and subcutaneous abdominal fat (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02029833, which also lists 2 linked publications.
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 17 Mar 2023.