Metabolic SyndromeMETCO-2013NCT01890330
Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome
A study testing Canola Oil 25 g/d and Non-Canola Oil Mixture 25 g/d in people with Metabolic Syndrome, run by University of Manitoba at 1 site in Canada.
Trial summary
MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS is a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low HDL-cholesterol, hypertension, elevated fasting blood glucose) accompanied by low grade chronic inflammation, hepatic steatosis (fatty liver)… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Canola Oil 25 g/d and Non-Canola Oil Mixture 25 g/d
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, or non-pregnant, non-lactating females, aged 20 - 75 years;
- LDL-Cholesterol >2.5 mmol/L and <5.0 mmol/L
- If the participant has 2 or more of the following characteristics of MetS
- Fasting blood glucose >5.6 mmol/L and <7.0 mmol/L;
- Blood pressure >130/85 mm Hg and <150/100;
- Triglycerides >1.7 mmol/L and <4.0 mmol/L;
Show all 13Show fewer
- HDL-cholesterol <1.0 mmol/L in males or <1.3 mmol/L in females;
- Abdominal obesity as defined by a waist circumference of >102 cm (40 inches) in males and >88 cm (35 inches) in females of non-Asian ethnicity, and a waist circumference of >94 cm (37 inches) in males and >80 cm (32 inches) in females of Asian ethnicity.
- Able to read, write and communicate orally in English;
- Willing to maintain a stable level of activity during participation in the study;
- Willing to maintain dietary routine, refrain from consuming omega-3 supplements or omega-3 rich foods (>0.3 grams ALA/serving or, >0.1 grams of EPA and DHA; see handout with examples) and refrain from taking any over-the-counter medications or herbal supplements specified for weight loss, or the lowering of blood lipids, blood glucose or blood pressure from acceptance into the study until the final study visit;
- Willing to comply with protocol requirements and procedures;
- Willing to provide written informed consent.
Who cannot join
- Use of prescribed medications for lowering or managing blood lipids (hyperlipidemia), blood glucose (hyper/hypoglycemia), blood pressure (hypertension) or body weight;
- Regular use of non-prescription products, over-the-counter medications, or herbal supplements designed to lower blood lipids, blood glucose, blood pressure or body weight, or omega-3 supplements or omega-3 rich foods, within the past 3 months;
- Participating in or adhering to a weight loss diet or physical activity program designed to facilitate weight loss.
- Adhering to a physician or dietitian directed lifestyle or dietary modification program for the purpose of lowering hypercholesterolemia;
- Medical history of liver disease, with the exception of fatty liver, or chronic renal disease;
- 5. Any acute medical condition or surgical intervention within the past 3 months; 6. Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results; 7. History of gastrointestinal reactions or allergies to canola oil or to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed; and 8. Currently participating in or having participated in a food intervention study within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Boniface General Hospital - I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
About this study
MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS is a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low HDL-cholesterol, hypertension, elevated fasting blood glucose) accompanied by low grade chronic inflammation, hepatic steatosis (fatty liver) and reduced vascular function.
This study will investigate the effect of a 12 week intervention with canola oil versus the typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS parameters. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.
Read the detailed description
The current, worldwide obesity epidemic is significantly increasing the number of individuals with Metabolic Syndrome (MetS), an early stage combination of risk factors which predisposes individuals to cardiovascular disease (CVD) and other chronic diseases. While it has been shown that modification of dietary fat intake can play an important role in prevention and management of CVD there is an absence of dietary intervention studies focusing on dietary oils and early stage modification of MetS components, particularly those affecting progression to CVD.
The composition of canola oil is considered healthy. However, there is a lack of scientifically sound clinical studies directly comparing canola oil with other fats in the diet. Given that much of the evidence for current dietary recommendations for type and amounts of fatty acids is based on heart disease, the proposed research will contribute to the knowledge base for dietary fat recommendations for individuals with MetS.
Specifically, this study will investigate the effect of a 12 week intervention with canola oil versus the typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS parameters. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.
- Conditions
- Metabolic Syndrome
- Being tested
- Canola Oil 25 g/d, Non-Canola Oil Mixture 25 g/d
- Keywords
- Canola Oil, Metabolic Syndrome, Serum LDL cholesterol
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canola Oil 25 g/dOther
Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.
Non-Canola Oil Mixture 25 g/dOther
Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Canola Oil 25 g/d | Experimental | Participants randomized to this arm will be provided with food items including entrées, side dishes, salad dressing, baked goods, and desserts prepared with traditional canola oil to incorporate into their usual eating pattern. They will consume one or two food items per day containing a total of 25 g/d of Canola oil. Receives: Other: Canola Oil 25 g/d |
| Non-Canola Oil Mixture 25 g/d | Active comparator | Participants randomized to this arm will be provided with food items including entrées, side dishes, salad dressing, baked goods, and desserts prepared with an oil mixture representing the typical Western diet to incorporate into their usual eating pattern. They will consume one or two food items per day containing a total of 25 g/d of the non-canola oil mixture. Receives: Other: Non-Canola Oil Mixture 25 g/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fasting Serum LDL-cholesterol
Fasting blood sample will be taken at Baseline (Day 1), Week 6 (Day 56) amd Week 12 (Day 84) for purpose of analysis of Serum LDL-Cholesterol.
Measured: Baseline, Week 6 and Week 12
Secondary outcomes (13)
Change in Blood Vessel Function
Blood vessel function will assessed and compared at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) via pulse wave analysis and pulse ave velocity.
Measured: Baseline, Week 6 and Week 12
Change in Total Cholesterol
A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of serum total cholesterol
Measured: Baseline, Week 6, and Week 12
Change in Advanced Glycation Endproducts (AGEs)
Advanced Glycation Endproducts (AGEs) will be obtained and compared at Baseline (Day 1), Week 6 (Day 56), and Week 12 (Day 84) using the AGE Reader.
Measured: Baseline, Week 6, and Week 12
Change in Biomarkers of Vascular Function
A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56), and Week 12 (Day 84) for the assessment and comparison of biomarkers of vascular function, inflammation, oxidative stress, and immune function.
Measured: Baseline, Week 6 and Week 12
Change in Total Body Fat Composition
Participants will undergo a body composition scan using a GE Lunar Dual Energy X-Ray Absorptiometry scanner to determine the percentage of total body fat, abdominal fat, and percentage of lean muscle mass at Baseline (Day 1) and Week 12 (Day 84).
Measured: Baseline and Week 12
Change in Fatty Liver
Fatty liver will be assessed through serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Measured: Baseline and Week 12
Change in Anthropometrics
Weight, body mass index (BMI), and waist circumference and will be obtained and compared at with Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84).
Measured: Baseline, Week 6 and Week 12
Change in HDL-Cholesterol
A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of HDL-cholesterol.
Measured: Baseline, Week 6, and Week 12
Change in Triglycerides
A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of serum triglycerides.
Measured: Baseline, Week 6, and Week 12
Change in Fasting Blood Glucose
A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of glucose.
Measured: Baseline, Week 6 and Week 12
Change in Fasting Insulin
A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of insulin (and calculation of insulin sensitivity using HOMA-IR, QUICKI).
Measured: Baseline, Week 6 and Week 12
Change in Glycated Hemoglobin (HbA1c)
A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of glycated hemoglobin (HbA1c).
Measured: Baseline, Week 6 and Week 12
Change in fasting C-reactive protein
A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of C-reactive protein.
Measured: Baseline, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Bio Solutions, Alberta Canola Producers Commission, Canola Council of Canada
- Responsible party
- Principal investigator, Dr. Carla Taylor, University of Manitoba
- Investigators
- Carla Taylor, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890330
- Sponsor's protocol ID
- B2013:006
- Acronym
- METCO-2013
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2013
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
PubMed 17167477Jakobsen MU, O'Reilly EJ, Heitmann BL, Pereira MA, Balter K, Fraser GE, Goldbourt U, Hallmans G, Knekt P, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Ascherio A. Major types of dietary fat and risk of coronary heart disease: a pooled analysis of 11 cohort studies. Am J Clin Nutr. 2009 May;89(5):1425-32. doi: 10.3945/ajcn.2008.27124. Epub 2009 Feb 11.
PubMed 19211817Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.
PubMed 33380172
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01890330
- Acronym / sponsor ID
- METCO-2013 / B2013:006
- Conditions
- Metabolic Syndrome
- Keywords
- Canola Oil, Metabolic Syndrome, Serum LDL cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Alberta Innovates Bio Solutions, Alberta Canola Producers Commission, Canola Council of Canada
- Study start
- Jul 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Jul 2013 (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.
MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS is a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low HDL-cholesterol, hypertension, elevated fasting blood glucose) accompanied by low grade chronic inflammation, hepatic steatosis (fatty liver) and reduced vascular function.
This study will investigate the effect of a 12 week intervention with canola oil versus the typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS parameters. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.
Detailed description
The current, worldwide obesity epidemic is significantly increasing the number of individuals with Metabolic Syndrome (MetS), an early stage combination of risk factors which predisposes individuals to cardiovascular disease (CVD) and other chronic diseases. While it has been shown that modification of dietary fat intake can play an important role in prevention and management of CVD there is an absence of dietary intervention studies focusing on dietary oils and early stage modification of MetS components, particularly those affecting progression to CVD.
The composition of canola oil is considered healthy. However, there is a lack of scientifically sound clinical studies directly comparing canola oil with other fats in the diet. Given that much of the evidence for current dietary recommendations for type and amounts of fatty acids is based on heart disease, the proposed research will contribute to the knowledge base for dietary fat recommendations for individuals with MetS.
Specifically, this study will investigate the effect of a 12 week intervention with canola oil versus the typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS parameters. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canola Oil 25 g/d | Experimental | Other: Canola Oil 25 g/dParticipants randomized to this arm will be provided with food items including entrées, side dishes, salad dressing, baked goods, and desserts prepared with traditional canola oil to incorporate into their usual eating pattern. They will consume one or two food items per day containing a total of 25 g/d of Canola oil. |
| Non-Canola Oil Mixture 25 g/d | Active comparator | Other: Non-Canola Oil Mixture 25 g/dParticipants randomized to this arm will be provided with food items including entrées, side dishes, salad dressing, baked goods, and desserts prepared with an oil mixture representing the typical Western diet to incorporate into their usual eating pattern. They will consume one or two food items per day containing a total of 25 g/d of the non-canola oil mixture. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male, or non-pregnant, non-lactating females, aged 20 - 75 years;
- LDL-Cholesterol >2.5 mmol/L and <5.0 mmol/L
- If the participant has 2 or more of the following characteristics of MetS
- Able to read, write and communicate orally in English;
- Willing to maintain a stable level of activity during participation in the study;
Key exclusion criteria (6 listed)
- Use of prescribed medications for lowering or managing blood lipids (hyperlipidemia), blood glucose (hyper/hypoglycemia), blood pressure (hypertension) or body weight;
- Regular use of non-prescription products, over-the-counter medications, or herbal supplements designed to lower blood lipids, blood glucose, blood pressure or body weight, or omega-3 supplements or omega-3 rich foods, within the past 3 months;
- Participating in or adhering to a weight loss diet or physical activity program designed to facilitate weight loss.
- Adhering to a physician or dietitian directed lifestyle or dietary modification program for the purpose of lowering hypercholesterolemia;
- Medical history of liver disease, with the exception of fatty liver, or chronic renal disease;
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 Oil 25 g/dDaily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks. | Other | Canola Oil 25 g/d |
| Non-Canola Oil Mixture 25 g/dDaily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks. | Other | Non-Canola Oil Mixture 25 g/d |
Primary outcome
Change in Fasting Serum LDL-cholesterol
Time frame: Baseline, Week 6 and Week 12
Fasting blood sample will be taken at Baseline (Day 1), Week 6 (Day 56) amd Week 12 (Day 84) for purpose of analysis of Serum LDL-Cholesterol.
13 secondary outcomes
Change in Blood Vessel Function
Time frame: Baseline, Week 6 and Week 12
Change in Total Cholesterol
Time frame: Baseline, Week 6, and Week 12
Change in Advanced Glycation Endproducts (AGEs)
Time frame: Baseline, Week 6, and Week 12
Change in Biomarkers of Vascular Function
Time frame: Baseline, Week 6 and Week 12
Change in Total Body Fat Composition
Time frame: Baseline and Week 12
Change in Fatty Liver
Time frame: Baseline and Week 12
Change in Anthropometrics
Time frame: Baseline, Week 6 and Week 12
Change in HDL-Cholesterol
Time frame: Baseline, Week 6, and Week 12
Change in Triglycerides
Time frame: Baseline, Week 6, and Week 12
Change in Fasting Blood Glucose
Time frame: Baseline, Week 6 and Week 12
Change in Fasting Insulin
Time frame: Baseline, Week 6 and Week 12
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, Week 6 and Week 12
Change in fasting C-reactive protein
Time frame: Baseline, Week 6 and Week 12
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 8 Sep 2025.
- Background: PubMed 17167477Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
- Results publication: PubMed 19211817Jakobsen MU, O'Reilly EJ, Heitmann BL, Pereira MA, Balter K, Fraser GE, Goldbourt U, Hallmans G, Knekt P, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Ascherio A. Major types of dietary fat and risk of coronary heart disease: a pooled analysis of 11 cohort studies. Am J Clin Nutr. 2009 May;89(5):1425-32. doi: 10.3945/ajcn.2008.27124. Epub 2009 Feb 11.
- Derived from this study: PubMed 33380172Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.
- Canadian Centre for Agri-Food Research in Health and MedicineLink provided by the sponsor.
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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.
Carla Taylor, PhD principal investigator
University of Manitoba
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 25 g/d and Non-Canola Oil Mixture 25 g/d 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 13 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 8 Sep 2025. 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. 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 Fasting Serum LDL-cholesterol (time frame: Baseline, Week 6 and Week 12). 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 NCT01890330, which also lists 3 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 8 Sep 2025.