Cardiovascular DiseasePhase 2NCT00927199
Efficacy of High-oleic Canola and Flaxseed Oils for Hypercholesterolemia and Cardiovascular Disease Risk Factors
A Phase 2 study testing High-Oleic Canola Oil and High-Oleic Canola/Flaxseed Oil Blend in people with Cardiovascular Disease, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to assess the efficacy of high-oleic canola oil and a high-oleic canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- High-Oleic Canola Oil and High-Oleic Canola/Flaxseed Oil Blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Jun 2008
- Phase
- Phase 2
- 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
- Fasting serum LDL-Cholesterol >3.0 mmol/L
- Body mass index (BMI) between 22-36 kg/m2
Who cannot join
- smoking
- use of lipid lowering therapy
- documented cardiovascular/atherosclerotic disease
- inflammatory disease
- diabetes
- uncontrolled hypertension
Show all 11Show fewer
- kidney disease
- other systemic diseases
- cancer
- chronic alcohol consumption (> 2 servings/day)
- excessive exercise expenditure (> 4000 kcal/week)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
About this study
Official title: Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors
The purpose of this study is to assess the efficacy of high-oleic canola oil and a high-oleic canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic patients. Furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid contained in high-oleic canola oil and flaxseed oil will be investigated.
- Conditions
- Cardiovascular Disease
- Being tested
- High-Oleic Canola Oil, High-Oleic Canola/Flaxseed Oil Blend, Western Dietary Control
- Keywords
- High-Oleic Canola Oil, Flaxseed Oil, Monounsaturated Fatty Acids, Polyunsaturated Fatty Acids, Alpha Linolenic Acid, Cardiovascular, Hypercholesterolemia, Lipids, Inflammation, Metabolism
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Oleic Canola OilDietary supplement
Diets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid))
High-Oleic Canola/Flaxseed Oil BlendDietary supplement
Diets contained 35% energy as fat; of which 70% was provided by a 1:1 blend of high-oleic canola oil and flaxseed oil (high in monounsaturated fat (oleic acid) and omega-3 polyunsaturated fat (alpha-linolenic acid))
Western Dietary ControlDietary supplement
Diets contained 35% energy as fat; of which 70% was provided by a blend of oils typical to the Western diet (high in saturated fat and omega-6 polyunsaturated fat (linoleic acid))
| Study group | Role | What they receive |
|---|---|---|
| High-Oleic Canola Oil | Experimental | Not described Receives: Dietary Supplement: High-Oleic Canola Oil |
| High-Oleic Canola/Flaxseed Oil Blend | Experimental | Not described Receives: Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend |
| Western Diet | Active comparator | Not described Receives: Dietary Supplement: Western Dietary Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Lipids
Measured: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Inflammatory Biomarkers: C-Reactive Protein, Interleukin-6, sE-Selectin, sVCAM-1, sICAM-1
Measured: Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Intima-Medial Thickness by Carotid Ultrasound
Measured: Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
Energy Expenditure by Indirect Calorimetry
Measured: Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)
Measured: Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
Oxidation and Conversion of U-13C-Alpha Linolenic Acid
Measured: Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase
Plasma Fatty Acid Concentrations
Measured: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Secondary outcomes (1)
Arterial Stiffness Index by Pulse Wave Analysis
Measured: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canola Council of Canada, Flax Canada 2015 Inc., Agri-Food Research and Development Initiative
- Investigators
- Peter JH Jones, PhD, Principal investigator, University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927199
- Sponsor's protocol ID
- B2007:071
- Status last verified
- Jan 2013
- First submitted
- 17 Jun 2009
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gillingham LG, Harris-Janz S, Jones PJ. Dietary monounsaturated fatty acids are protective against metabolic syndrome and cardiovascular disease risk factors. Lipids. 2011 Mar;46(3):209-28. doi: 10.1007/s11745-010-3524-y. Epub 2011 Feb 10.
PubMed 21308420Gillingham LG, Harding SV, Rideout TC, Yurkova N, Cunnane SC, Eck PK, Jones PJ. Dietary oils and FADS1-FADS2 genetic variants modulate [13C]alpha-linolenic acid metabolism and plasma fatty acid composition. Am J Clin Nutr. 2013 Jan;97(1):195-207. doi: 10.3945/ajcn.112.043117. Epub 2012 Dec 5.
PubMed 23221573Gillingham LG, Robinson KS, Jones PJ. Effect of high-oleic canola and flaxseed oils on energy expenditure and body composition in hypercholesterolemic subjects. Metabolism. 2012 Nov;61(11):1598-605. doi: 10.1016/j.metabol.2012.04.016. Epub 2012 Jun 12.
PubMed 22698766Gillingham LG, Gustafson JA, Han SY, Jassal DS, Jones PJ. High-oleic rapeseed (canola) and flaxseed oils modulate serum lipids and inflammatory biomarkers in hypercholesterolaemic subjects. Br J Nutr. 2011 Feb;105(3):417-27. doi: 10.1017/S0007114510003697. Epub 2010 Sep 29.
PubMed 20875216Jones PJ, Lin L, Gillingham LG, Yang H, Omar JM. Modulation of plasma N-acylethanolamine levels and physiological parameters by dietary fatty acid composition in humans. J Lipid Res. 2014 Dec;55(12):2655-64. doi: 10.1194/jlr.P051235. Epub 2014 Sep 28.
PubMed 25262934
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00927199
- Acronym / sponsor ID
- B2007:071
- Conditions
- Cardiovascular Disease
- Keywords
- High-Oleic Canola Oil, Flaxseed Oil, Monounsaturated Fatty Acids, Polyunsaturated Fatty Acids, Alpha Linolenic Acid, Cardiovascular, Hypercholesterolemia, Lipids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canola Council of Canada, Flax Canada 2015 Inc., Agri-Food Research and Development Initiative
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 24 Jun 2009 (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 this study is to assess the efficacy of high-oleic canola oil and a high-oleic canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic patients. Furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid contained in high-oleic canola oil and flaxseed oil will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Oleic Canola Oil | Experimental | Dietary Supplement: High-Oleic Canola Oil |
| High-Oleic Canola/Flaxseed Oil Blend | Experimental | Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend |
| Western Diet | Active comparator | Dietary Supplement: Western Dietary Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fasting serum LDL-Cholesterol >3.0 mmol/L
- Body mass index (BMI) between 22-36 kg/m2
Key exclusion criteria (11 listed)
- smoking
- use of lipid lowering therapy
- documented cardiovascular/atherosclerotic disease
- inflammatory disease
- diabetes
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 |
|---|---|---|
| High-Oleic Canola OilDiets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid)) | Dietary supplement | High-Oleic Canola Oil |
| High-Oleic Canola/Flaxseed Oil BlendDiets contained 35% energy as fat; of which 70% was provided by a 1:1 blend of high-oleic canola oil and flaxseed oil (high in monounsaturated fat (oleic acid) and omega-3 polyunsaturated fat (alpha-linolenic acid)) | Dietary supplement | High-Oleic Canola/Flaxseed Oil Blend |
| Western Dietary ControlDiets contained 35% energy as fat; of which 70% was provided by a blend of oils typical to the Western diet (high in saturated fat and omega-6 polyunsaturated fat (linoleic acid)) | Dietary supplement | Western Diet |
Primary outcome
Serum Lipids
Time frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Inflammatory Biomarkers: C-Reactive Protein, Interleukin-6, sE-Selectin, sVCAM-1, sICAM-1
Time frame: Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Intima-Medial Thickness by Carotid Ultrasound
Time frame: Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
Energy Expenditure by Indirect Calorimetry
Time frame: Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)
Time frame: Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
Oxidation and Conversion of U-13C-Alpha Linolenic Acid
Time frame: Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase
Plasma Fatty Acid Concentrations
Time frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
1 secondary outcome
Arterial Stiffness Index by Pulse Wave Analysis
Time frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
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 1 Feb 2013.
- Background: PubMed 21308420Gillingham LG, Harris-Janz S, Jones PJ. Dietary monounsaturated fatty acids are protective against metabolic syndrome and cardiovascular disease risk factors. Lipids. 2011 Mar;46(3):209-28. doi: 10.1007/s11745-010-3524-y. Epub 2011 Feb 10.
- Results publication: PubMed 23221573Gillingham LG, Harding SV, Rideout TC, Yurkova N, Cunnane SC, Eck PK, Jones PJ. Dietary oils and FADS1-FADS2 genetic variants modulate [13C]alpha-linolenic acid metabolism and plasma fatty acid composition. Am J Clin Nutr. 2013 Jan;97(1):195-207. doi: 10.3945/ajcn.112.043117. Epub 2012 Dec 5.
- Results publication: PubMed 22698766Gillingham LG, Robinson KS, Jones PJ. Effect of high-oleic canola and flaxseed oils on energy expenditure and body composition in hypercholesterolemic subjects. Metabolism. 2012 Nov;61(11):1598-605. doi: 10.1016/j.metabol.2012.04.016. Epub 2012 Jun 12.
- Results publication: PubMed 20875216Gillingham LG, Gustafson JA, Han SY, Jassal DS, Jones PJ. High-oleic rapeseed (canola) and flaxseed oils modulate serum lipids and inflammatory biomarkers in hypercholesterolaemic subjects. Br J Nutr. 2011 Feb;105(3):417-27. doi: 10.1017/S0007114510003697. Epub 2010 Sep 29.
- Derived from this study: PubMed 25262934Jones PJ, Lin L, Gillingham LG, Yang H, Omar JM. Modulation of plasma N-acylethanolamine levels and physiological parameters by dietary fatty acid composition in humans. J Lipid Res. 2014 Dec;55(12):2655-64. doi: 10.1194/jlr.P051235. Epub 2014 Sep 28.
- Richardson Centre for Functional Foods and Nutraceuticals - website home pageLink 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.
Peter JH Jones, PhD principal investigator
University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-Oleic Canola Oil and High-Oleic Canola/Flaxseed Oil Blend in people with Cardiovascular Disease, 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 2 inclusion and 11 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 1 Feb 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum Lipids (time frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase). The study lists 7 primary outcomes in all. 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 NCT00927199, which also lists 5 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 1 Feb 2013.