Metabolic SyndromeCOMITNCT01351012
Canola Oil Multicentre Intervention Trial
A study testing Corn and safflower oil, Canola oil and High oleic acid canola oil in people with Metabolic Syndrome, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of the study is to examine how the consumption of different dietary oil varieties affects a broad range of metabolic responses that are important in the development of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Corn and safflower oil, Canola oil and High oleic acid canola oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Apr 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waist circumference ≥94 cm (males) or ≥80 cm (females)
- plus at least one of the following:
- Triglycerides ≥1.7 mmol/L
- High density lipoprotein (HDL) cholesterol <1 mmol/L (males) or <1.3 mmol/L (females)
- Low density lipoprotein (LDL) cholesterol ≥3.5 mmol/L
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
- Glucose ≥5.5 mmol/L
Who cannot join
- Thyroid disease
- Diabetes mellitus
- Kidney disease
- Liver disease
- Smoking
- Heavy drinking
- Use of medication known to affect lipid metabolism during the last 3 months(cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk
The purpose of the study is to examine how the consumption of different dietary oil varieties affects a broad range of metabolic responses that are important in the development of cardiovascular diseases. This study will examine the relationship between dietary oil consumption and arterial function, blood fat content, and blood markers of cardiovascular disease risk. Additionally, the efficiency of the body in converting fat from dietary oils into other specific fat compounds with know health benefits will be examined. Also, the correlation between psychosocial parameters and vascular function will be studied.
Read the detailed description
Although consumption of omega-3 fatty acids favorably modulate circulating lipids and arterial health, there is confusion surrounding the specific health benefits of plant based alpha-linolenic acid (ALA) versus marine derived eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This research will examine the health benefits of ALA from consumption of diets rich in canola oil, novel monounsaturated fatty acid (MUFA) and DHA enriched canola oils, and flax oil compared with a control diet representative of North American diets rich in omega-6 and saturated fats. Treatment oils will be examined for potential influence on endothelial dysfunction, inflammation, oxidation, body composition, and plasma lipoprotein characterization. Furthermore, in an effort to elucidate the genetic factors that promote ALA conversion to EPA/DHA and strengthen the role of ALA in cardiovascular health, a major objective is to correlate common genetic variants in the fatty acid desaturase 1 (FADS1) and fatty acid desaturase 2 (FADS2) gene cluster with ALA conversion to EPA/DHA and n-3 fatty acid composition of serum phospholipids in response to consumption of the treatment oils. Besides, psychosocial predictors of vascular function will be investigated.
- Conditions
- Metabolic Syndrome
- Being tested
- Corn and safflower oil, Canola oil, High oleic acid canola oil, DHA enriched high oleic acid canola oil, Flax and safflower oil
- Keywords
- Canola oil, High oleic canola oil, Flax oil, ALA, DHA, Metabolic syndrome, Cardiovascular disease, Endothelial function, FADS1, Gut microbiome, Body composition, Psychosocial status, Cholesterol, Lipids, Lipoproteins, Inflammation, Lipid peroxidation
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn and safflower oilOther
The oil (60 g/d/3000 kcal) is given in two daily fruit shakes for 4 weeks
Canola oilOther
The oil (60 g/d/3000 kcal providing 3.8 g ALA) is given in two daily fruit shakes for 4 weeks
High oleic acid canola oilOther
The oil (60 g/d/3000 kcal providing 41.2 g oleic acid and 1.2 g ALA) is given in two daily fruit shakes for 4 weeks
DHA enriched high oleic acid canola oilOther
The oil (60 g/d/3000 kcal providing 1.2 g of ALA and 3.6 g of DHA) is given in two daily fruit shakes for 4 weeks
Flax and safflower oilOther
The oil (60 g/d/3000 kcal providing 6.9 g of ALA) is given in two daily fruit shakes for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Corn and safflower oil | Placebo comparator | Not described Receives: Other: Corn and safflower oil |
| Canola oil | Active comparator | Not described Receives: Other: Canola oil |
| High oleic acid canola oil | Active comparator | Not described Receives: Other: High oleic acid canola oil |
| DHA enriched high oleic acid canola oil | Active comparator | Not described Receives: Other: DHA enriched high oleic acid canola oil |
| Flax and safflower oil | Active comparator | Not described Receives: Other: Flax and safflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function
Non-invasive peripheral arterial tonometry (EndoPAT) is used to assess endothelial function.
Measured: Endothelial function will be measured at baseline and at the end of each of the five 4-week treatment phases over a period of nine months.
Secondary outcomes (6)
Change in ALA conversion to EPA/DHA
On day 28 of each experimental phase, a fasting baseline blood sample is taken prior to administration of an oral dose of deuterium oxide containing a higher than normal proportion of the hydrogen isotope deuterium (2H). Fasting blood samples will be obtained 24 h following the tracer dose. Enrichment of 2H in EPA and DHA plasma triglycerides, non-esterified fatty acids, and phosphatidylcholine will be measured by GC-combustion isotope-ratio mass spectrometry.
Measured: Blood samples will be collected at the end of each of the five 4-week treatment phases over a period of nine months.
Change in body composition
Changes in body composition will be assessed using dual-energy X-ray absorptiometry (DXA) scans. Also, a MRI scan will be performed on each subject at the start of the study.
Measured: Measurements will be done at the start and end of each of the five 4-week treatment phases over a period of nine months.
Change in FADS 1 & 2 mRNA and protein expression
mRNA and protein expression of genes/proteins involved in fatty acid metabolism will be analyzed using standard RT-PCR and immunoblotting protocols.
Measured: Blood samples will be collected at the end of each of the five 4-week treatment phases over a nine-month period.
Change in psychosocial correlates
Subjects will complete questionnaires regarding their mood and recent sleep (state questionnaires) and a questionnaire regarding their overall mood, social support and behaviors (trait questionnaire).
Measured: Measurements are done at baseline, at the start of the fifth treatment phase and at the end of each of the five 4-week treatment phases.
Change in plasma lipids and lipoproteins, inflammatory cytokines and peroxidation biomarkers
Measured: Blood samples are collected at the start and end of each of the five 4-week treatment phases over a nine-month period.
Blood Pressure
Blood pressure data (change in both systolic and diastolic) was taken 3 times at the baseline and endpoint of each phase of the trial. 2nd and 3rd measures were averaged.
Measured: Over 3 years; at baseline and endpoint of each 4-week treatment phases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Penn State University, Laval University
- Responsible party
- Principal investigator, Dr. Peter Jones, University of Manitoba
- Investigators
- Peter JH Jones, PhD, Study chair, University of ManitobaDavid Jenkins, PhD, Principal investigator, University of TorontoPenny Kris-Etherton, PhD, RD, Principal investigator, Penn State UniversitySheila West, PhD, Principal investigator, Penn State UniversityBenoit Lamarche, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351012
- Sponsor's protocol ID
- B2010:047
- Acronym
- COMIT
- Status last verified
- Feb 2014
- First submitted
- 14 Mar 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu X, Garban J, Jones PJ, Vanden Heuvel J, Lamarche B, Jenkins DJ, Connelly PW, Couture P, Pu S, Fleming JA, West SG, Kris-Etherton PM. Diets Low in Saturated Fat with Different Unsaturated Fatty Acid Profiles Similarly Increase Serum-Mediated Cholesterol Efflux from THP-1 Macrophages in a Population with or at Risk for Metabolic Syndrome: The Canola Oil Multicenter Intervention Trial. J Nutr. 2018 May 1;148(5):721-728. doi: 10.1093/jn/nxy040.
PubMed 30053283Liu X, Kris-Etherton PM, West SG, Lamarche B, Jenkins DJ, Fleming JA, McCrea CE, Pu S, Couture P, Connelly PW, Jones PJ. Effects of canola and high-oleic-acid canola oils on abdominal fat mass in individuals with central obesity. Obesity (Silver Spring). 2016 Nov;24(11):2261-2268. doi: 10.1002/oby.21584.
PubMed 27804268Jones PJ, MacKay DS, Senanayake VK, Pu S, Jenkins DJ, Connelly PW, Lamarche B, Couture P, Kris-Etherton PM, West SG, Liu X, Fleming JA, Hantgan RR, Rudel LL. High-oleic canola oil consumption enriches LDL particle cholesteryl oleate content and reduces LDL proteoglycan binding in humans. Atherosclerosis. 2015 Feb;238(2):231-8. doi: 10.1016/j.atherosclerosis.2014.12.010. Epub 2014 Dec 9.
PubMed 25528432Baril-Gravel L, Labonte ME, Couture P, Vohl MC, Charest A, Guay V, Jenkins DA, Connelly PW, West S, Kris-Etherton PM, Jones PJ, Fleming JA, Lamarche B. Docosahexaenoic acid-enriched canola oil increases adiponectin concentrations: a randomized crossover controlled intervention trial. Nutr Metab Cardiovasc Dis. 2015 Jan;25(1):52-9. doi: 10.1016/j.numecd.2014.08.003. Epub 2014 Aug 20.
PubMed 25240692Jones PJ, Senanayake VK, Pu S, Jenkins DJ, Connelly PW, Lamarche B, Couture P, Charest A, Baril-Gravel L, West SG, Liu X, Fleming JA, McCrea CE, Kris-Etherton PM. DHA-enriched high-oleic acid canola oil improves lipid profile and lowers predicted cardiovascular disease risk in the canola oil multicenter randomized controlled trial. Am J Clin Nutr. 2014 Jul;100(1):88-97. doi: 10.3945/ajcn.113.081133. Epub 2014 May 14.
PubMed 24829493Senanayake VK, Pu S, Jenkins DA, Lamarche B, Kris-Etherton PM, West SG, Fleming JA, Liu X, McCrea CE, Jones PJ. Plasma fatty acid changes following consumption of dietary oils containing n-3, n-6, and n-9 fatty acids at different proportions: preliminary findings of the Canola Oil Multicenter Intervention Trial (COMIT). Trials. 2014 Apr 23;15:136. doi: 10.1186/1745-6215-15-136.
PubMed 24754911
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT01351012
- Acronym / sponsor ID
- COMIT / B2010:047
- Conditions
- Metabolic Syndrome
- Keywords
- Canola oil, High oleic canola oil, Flax oil, ALA, DHA, Metabolic syndrome, Cardiovascular disease, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Toronto, Penn State University, Laval University
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 May 2011 (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 purpose of the study is to examine how the consumption of different dietary oil varieties affects a broad range of metabolic responses that are important in the development of cardiovascular diseases. This study will examine the relationship between dietary oil consumption and arterial function, blood fat content, and blood markers of cardiovascular disease risk. Additionally, the efficiency of the body in converting fat from dietary oils into other specific fat compounds with know health benefits will be examined. Also, the correlation between psychosocial parameters and vascular function will be studied.
Detailed description
Although consumption of omega-3 fatty acids favorably modulate circulating lipids and arterial health, there is confusion surrounding the specific health benefits of plant based alpha-linolenic acid (ALA) versus marine derived eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This research will examine the health benefits of ALA from consumption of diets rich in canola oil, novel monounsaturated fatty acid (MUFA) and DHA enriched canola oils, and flax oil compared with a control diet representative of North American diets rich in omega-6 and saturated fats. Treatment oils will be examined for potential influence on endothelial dysfunction, inflammation, oxidation, body composition, and plasma lipoprotein characterization. Furthermore, in an effort to elucidate the genetic factors that promote ALA conversion to EPA/DHA and strengthen the role of ALA in cardiovascular health, a major objective is to correlate common genetic variants in the fatty acid desaturase 1 (FADS1) and fatty acid desaturase 2 (FADS2) gene cluster with ALA conversion to EPA/DHA and n-3 fatty acid composition of serum phospholipids in response to consumption of the treatment oils. Besides, psychosocial predictors of vascular function will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Corn and safflower oil | Placebo comparator | Other: Corn and safflower oil |
| Canola oil | Active comparator | Other: Canola oil |
| High oleic acid canola oil | Active comparator | Other: High oleic acid canola oil |
| DHA enriched high oleic acid canola oil | Active comparator | Other: DHA enriched high oleic acid canola oil |
| Flax and safflower oil | Active comparator | Other: Flax and safflower oil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Waist circumference ≥94 cm (males) or ≥80 cm (females)
- Triglycerides ≥1.7 mmol/L
- High density lipoprotein (HDL) cholesterol <1 mmol/L (males) or <1.3 mmol/L (females)
- Low density lipoprotein (LDL) cholesterol ≥3.5 mmol/L
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
Key exclusion criteria (7 listed)
- Thyroid disease
- Diabetes mellitus
- Kidney disease
- Liver disease
- Smoking
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 |
|---|---|---|
| Corn and safflower oilThe oil (60 g/d/3000 kcal) is given in two daily fruit shakes for 4 weeks | Other | Corn and safflower oil |
| Canola oilThe oil (60 g/d/3000 kcal providing 3.8 g ALA) is given in two daily fruit shakes for 4 weeks | Other | Canola oil |
| High oleic acid canola oilThe oil (60 g/d/3000 kcal providing 41.2 g oleic acid and 1.2 g ALA) is given in two daily fruit shakes for 4 weeks | Other | High oleic acid canola oil |
| DHA enriched high oleic acid canola oilThe oil (60 g/d/3000 kcal providing 1.2 g of ALA and 3.6 g of DHA) is given in two daily fruit shakes for 4 weeks | Other | DHA enriched high oleic acid canola oil |
| Flax and safflower oilThe oil (60 g/d/3000 kcal providing 6.9 g of ALA) is given in two daily fruit shakes for 4 weeks | Other | Flax and safflower oil |
Primary outcome
Change in endothelial function
Time frame: Endothelial function will be measured at baseline and at the end of each of the five 4-week treatment phases over a period of nine months.
Non-invasive peripheral arterial tonometry (EndoPAT) is used to assess endothelial function.
6 secondary outcomes
Change in ALA conversion to EPA/DHA
Time frame: Blood samples will be collected at the end of each of the five 4-week treatment phases over a period of nine months.
Change in body composition
Time frame: Measurements will be done at the start and end of each of the five 4-week treatment phases over a period of nine months.
Change in FADS 1 & 2 mRNA and protein expression
Time frame: Blood samples will be collected at the end of each of the five 4-week treatment phases over a nine-month period.
Change in psychosocial correlates
Time frame: Measurements are done at baseline, at the start of the fifth treatment phase and at the end of each of the five 4-week treatment phases.
Change in plasma lipids and lipoproteins, inflammatory cytokines and peroxidation biomarkers
Time frame: Blood samples are collected at the start and end of each of the five 4-week treatment phases over a nine-month period.
Blood Pressure
Time frame: Over 3 years; at baseline and endpoint of each 4-week treatment phases
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 19 Feb 2014.
- Derived from this study: PubMed 30053283Liu X, Garban J, Jones PJ, Vanden Heuvel J, Lamarche B, Jenkins DJ, Connelly PW, Couture P, Pu S, Fleming JA, West SG, Kris-Etherton PM. Diets Low in Saturated Fat with Different Unsaturated Fatty Acid Profiles Similarly Increase Serum-Mediated Cholesterol Efflux from THP-1 Macrophages in a Population with or at Risk for Metabolic Syndrome: The Canola Oil Multicenter Intervention Trial. J Nutr. 2018 May 1;148(5):721-728. doi: 10.1093/jn/nxy040.
- Derived from this study: PubMed 27804268Liu X, Kris-Etherton PM, West SG, Lamarche B, Jenkins DJ, Fleming JA, McCrea CE, Pu S, Couture P, Connelly PW, Jones PJ. Effects of canola and high-oleic-acid canola oils on abdominal fat mass in individuals with central obesity. Obesity (Silver Spring). 2016 Nov;24(11):2261-2268. doi: 10.1002/oby.21584.
- Derived from this study: PubMed 25528432Jones PJ, MacKay DS, Senanayake VK, Pu S, Jenkins DJ, Connelly PW, Lamarche B, Couture P, Kris-Etherton PM, West SG, Liu X, Fleming JA, Hantgan RR, Rudel LL. High-oleic canola oil consumption enriches LDL particle cholesteryl oleate content and reduces LDL proteoglycan binding in humans. Atherosclerosis. 2015 Feb;238(2):231-8. doi: 10.1016/j.atherosclerosis.2014.12.010. Epub 2014 Dec 9.
- Derived from this study: PubMed 25240692Baril-Gravel L, Labonte ME, Couture P, Vohl MC, Charest A, Guay V, Jenkins DA, Connelly PW, West S, Kris-Etherton PM, Jones PJ, Fleming JA, Lamarche B. Docosahexaenoic acid-enriched canola oil increases adiponectin concentrations: a randomized crossover controlled intervention trial. Nutr Metab Cardiovasc Dis. 2015 Jan;25(1):52-9. doi: 10.1016/j.numecd.2014.08.003. Epub 2014 Aug 20.
- Derived from this study: PubMed 24829493Jones PJ, Senanayake VK, Pu S, Jenkins DJ, Connelly PW, Lamarche B, Couture P, Charest A, Baril-Gravel L, West SG, Liu X, Fleming JA, McCrea CE, Kris-Etherton PM. DHA-enriched high-oleic acid canola oil improves lipid profile and lowers predicted cardiovascular disease risk in the canola oil multicenter randomized controlled trial. Am J Clin Nutr. 2014 Jul;100(1):88-97. doi: 10.3945/ajcn.113.081133. Epub 2014 May 14.
- Derived from this study: PubMed 24754911Senanayake VK, Pu S, Jenkins DA, Lamarche B, Kris-Etherton PM, West SG, Fleming JA, Liu X, McCrea CE, Jones PJ. Plasma fatty acid changes following consumption of dietary oils containing n-3, n-6, and n-9 fatty acids at different proportions: preliminary findings of the Canola Oil Multicenter Intervention Trial (COMIT). Trials. 2014 Apr 23;15:136. doi: 10.1186/1745-6215-15-136.
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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 JH Jones, PhD study chair
University of Manitoba
David Jenkins, PhD principal investigator
University of Toronto
Penny Kris-Etherton, PhD, RD 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 Corn and safflower oil, Canola oil and High oleic acid canola oil in people with Metabolic Syndrome, run by University of Manitoba at 1 site in Canada.
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 7 inclusion and 7 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 19 Feb 2014. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Change in endothelial function (time frame: Endothelial function will be measured at baseline and at the end of each of the five 4-week treatment phases over a period of nine months.). 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 NCT01351012, which also lists 6 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 19 Feb 2014; AzTrials last refreshed its copy on 2 Nov 2026.