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Peripheral Arterial DiseaseNCT01250275

Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease

A study testing traditional canola oil, high oleic canola oil and soybean oil in people with Peripheral Arterial Disease, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The fatty acid composition of canola oil will have beneficial acute and chronic effects on vascular function in individuals with peripheral arterial disease. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
traditional canola oil, high oleic canola oil and soybean oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteCanada
Study dates
Sep 2011to Feb 2013
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion Criteria:Healthy age-matched participants (acute phase of the study):

  • Healthy volunteers, male or female, > 40 years of age;
  • Body Mass Index 18-30;
  • Glycated hemoglobin <6.5%;
  • Fasting serum total cholesterol <4 mmol/L and triglycerides <2.5 mmol/L;
  • Blood pressure <140/90 mm Hg;
  • Ankle-brachial index of >0.9;
  • Willing to comply with the protocol requirements;
  • Willing to provide informed consent;
  • Participants having completed another food-related study are eligible to participate if it has been more than 3 months since their participation.

Inclusion criteria, peripheral arterial disease participants (acute and chronic phases of the study):

  • Male or female, > 40 years of age;
  • Documented peripheral arterial disease including those with claudication as defined by an ankle brachial index of ≤0.90 or asymptomatic carotid stenosis of >50%; or who have had a previous intervention for peripheral arterial disease;
  • Stable medication profile for the past 3 months with no changes anticipated for the duration of the acute or chronic phases;
  • Willing to comply with the protocol requirements;
  • Willing to provide informed consent;
  • Participants having completed another food study are eligible to participate if it has been more than 3 months since the study was completed.

Exclusion criteria, healthy age-matched participants (acute phase of the study):

  • Currently smoking, or smoking within the last 6 months (Note: cigar smoking on an occasional basis will be permitted);
  • Presence of a clinically diagnosed disease affecting the heart, liver, kidneys, lungs,gastrointestinal, endocrine or blood/immune systems that requires medical treatment;
  • Taking any prescribed medication within the last 3 months with the exception of anti-depressants, birth control and hormone (estrogen) replacement therapy;
  • Pregnancy;
  • Amputation of upper or lower extremity on both sides;
  • Has undergone a surgical procedure requiring local or general anesthetic within the last 3 months;
  • History of gastrointestinal reactions or allergies to dietary oils and other ingredients in banana bread such as wheat and eggs;
  • Daily consumption of omega-3 supplements.

Exclusion Criteria, Peripheral arterial disease participants (acute and chronic phases of the study):

  • Currently smoking, or smoking within the last 6 months (Note: cigar smoking on an occasional basis will be permitted);
  • Renal failure requiring dialysis;
  • Ongoing cardiovascular event (e.g. angina)or medical illness within the last 3 months;
  • Hormone (estrogen) replacement therapy;
  • Amputation of leg, foot, arm or hand; post mastectomy or post lymphadenectomy;
  • History of gastrointestinal reactions or allergies to dietary oils:for the acute study, to ingredients in banana bread such as wheat and eggs, ang for the chronic study, to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed;
  • Inability to adhere to a regular diet;
  • Daily consumption of omega-3 supplements.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • IH Asper Clinical Research Insitute, St. Boniface General Hospital

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease (PAD)

The fatty acid composition of canola oil will have beneficial acute and chronic effects on vascular function in individuals with peripheral arterial disease.

Read the detailed description

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 established cardiovascular disease. Specifically, this study will establish whether canola oil has positive effects on blood vessel function in individuals with peripheral arterial disease by measuring true clinical endpoints such as ankle-brachial index, walking distance, claudication, and vascular function measures. Additionally, since reduced blood flow contributes to cognitive impairment, this study will explore whether improvements in blood vessel function are also associated with improvements in cognitive function. Given the large proportion of the population affected by atherosclerosis and various forms of cardiovascular disease, there is significant potential for greater consumption and utilization of canola oil if there are beneficial effects on blood vessel function and other indicators of cardiovascular disease risk.

Being tested
traditional canola oil, high oleic canola oil, soybean oil, high linoleic safflower oil, coconut oil
Keywords
Canola Oil, Peripheral Arterial Disease, Peripheral Vascular Disease, PAD
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • traditional canola oilOther

    Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from traditional canola oil.

  • high oleic canola oilOther

    Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from high oleic canola oil.

  • soybean oilOther

    Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from soybean oil.

  • high linoleic safflower oilOther

    Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from high linoleic safflower oil.

  • coconut oilOther

    Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from coconut oil.

  • traditional canola oilOther

    Participants with peripheral arterial disease (n=25) will be randomized to daily consumption of food items prepared with traditional canola oil for eight weeks.

  • safflower oilOther

    Participants with peripheral arterial disease (n=25) will be randomized to daily consumption of foods prepared with an oil mixture representing the typical western diet

Study groups in NCT01250275
Study groupRoleWhat they receive
Acute Phase: traditional canola oilExperimentalParticipants will receive banana bread containing traditional canola oil once weekly during the 5-week schedule
Receives: Other: traditional canola oil
Acute Phase: high oleic canola oilActive comparatorParticipants will receive banana bread containing high oleic canola oil once weekly during the 5-week schedule
Receives: Other: high oleic canola oil
Acute Phase: soybean oilActive comparatorParticipants will receive banana bread containing soybean oil once weekly during the 5-week schedule
Receives: Other: soybean oil
Acute Phase: high linoleic safflower oilActive comparatorParticipants will receive banana bread containing high linoleic safflower oil once weekly during the 5-week schedule
Receives: Other: high linoleic safflower oil
Acute Phase: coconut oilActive comparatorParticipants will receive banana bread containing coconut oil once weekly during the 5-week schedule
Receives: Other: coconut oil
Chronic Phase: traditional canola oilExperimentalA total of 25 participants with peripheral arterial disease will be assigned foods containing traditional canola oil for a total of 8 weeks
Receives: Other: traditional canola oil
Chronic Phase: safflower oilActive comparatorA total of 25 participants with peripheral arterial disease will be assigned foods containing an oil mixture representing the typical western diet for a total of 8 weeks
Receives: Other: safflower oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute study to identify the relative potency of fatty acid compositions on blood vessel function in healthy participants and individuals with peripheral arterial disease.

    Participants (n=20,10 peripheral arterial disease/10 healthy) will attend 5 weekly visits and receive one food item (banana bread)at each visit. Assessment of endothelial function at 2-hours post consumption. Blood samples will be collected for plasma triglycerides, glucose, insulin, markers of oxidative stress, vascular function, inflammation, and metabolism. Food intake and physical activity will be recorded the day before their first test visit, and the same (foods and activities) will be repeated before each visit. Ankle Brachial Index and Pulse Wave Velocity testing will be done.

    Measured: weekly testing for 5 weeks

Secondary outcomes (3)

  1. To test the effects of canola oil consumption for its effects on vascular function and cardiovascular risk factors in a chronic 8-week study in individuals with peripheral arterial disease.

    Participants (n=50,peripheral arterial disease) will be randomly assigned (25 per group) to food items containing either traditional canola oil or an oil mixutre representing the Western diet. Assessments of vascular function, cognitive function, blood lipid profile, glycated hemoglobin, biomarkers of vascular function, inflammation, oxidative stress, immune function, and metabolism, advanced glycated endproducts, and anthropometrics will be completed at baseline and at 8 weeks.

    Measured: baseline and at 8 weeks

  2. To explore whether improvements in blood vessel function in the chronic 8-week study are also associated with improvements in cognitive function.

    Participants (n=50, 25/group) with peripheral arterial disease will be randomly assigned to receive daily food item(s) containing traditional canola oil or an oil mixture representing the Western diet. Assessment of cognitive function will occur at baseline and at the end of the 8-week study schedule.

    Measured: baseline and at 8 weeks

  3. 4. To assess compliance and tolerability through subjective feedback provided from participants during the chronic 8-week study.

    Participants (n=50, 25/group) with peripheral arterial disease will be randomly assigned to receive a daily food item(s) containing traditional canola oil or an oil mixture representing the Western diet. Compliance and tolerability with food consumption (including side effects) will be assessed from participants' experiences throughout the 8-week study schedule.

    Measured: baseline at at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2010 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2012
  4. Study completionFeb 2013

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01250275
Sponsor's protocol ID
B2010:125
Status last verified
Mar 2013
First submitted
29 Nov 2010
Last updated
27 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • Johnson GH, Keast DR, Kris-Etherton PM. Dietary modeling shows that the substitution of canola oil for fats commonly used in the United States would increase compliance with dietary recommendations for fatty acids. J Am Diet Assoc. 2007 Oct;107(10):1726-34. doi: 10.1016/j.jada.2007.07.015.

    PubMed 17904932

  • Toth PP. An urgent matter-identifying your patients' cardiovascular risk and improving their outcomes. Atherosclerosis: the underlying disease. J Fam Pract. 2009 Nov;58(11 Suppl Urgent):S19-25.

    PubMed 19891944

  • Poels MM, van Oijen M, Mattace-Raso FU, Hofman A, Koudstaal PJ, Witteman JC, Breteler MM. Arterial stiffness, cognitive decline, and risk of dementia: the Rotterdam study. Stroke. 2007 Mar;38(3):888-92. doi: 10.1161/01.STR.0000257998.33768.87. Epub 2007 Feb 1.

    PubMed 17272780

  • Waldstein SR, Rice SC, Thayer JF, Najjar SS, Scuteri A, Zonderman AB. Pulse pressure and pulse wave velocity are related to cognitive decline in the Baltimore Longitudinal Study of Aging. Hypertension. 2008 Jan;51(1):99-104. doi: 10.1161/HYPERTENSIONAHA.107.093674. Epub 2007 Nov 19.

    PubMed 18025297

  • Aslam F, Haque A, Foody J, Lee LV. Peripheral arterial disease: current perspectives and new trends in management. South Med J. 2009 Nov;102(11):1141-9. doi: 10.1097/SMJ.0b013e3181bb9ab8.

    PubMed 19864983

  • Mukherjee D, Cho L. Peripheral arterial disease: considerations in risks, diagnosis, and treatment. J Natl Med Assoc. 2009 Oct;101(10):999-1008. doi: 10.1016/s0027-9684(15)31066-x.

    PubMed 19860299

  • Carrero JJ, Lopez-Huertas E, Salmeron LM, Baro L, Ros E. Daily supplementation with (n-3) PUFAs, oleic acid, folic acid, and vitamins B-6 and E increases pain-free walking distance and improves risk factors in men with peripheral vascular disease. J Nutr. 2005 Jun;135(6):1393-9. doi: 10.1093/jn/135.6.1393.

    PubMed 15930443

  • Schiano V, Laurenzano E, Brevetti G, De Maio JI, Lanero S, Scopacasa F, Chiariello M. Omega-3 polyunsaturated fatty acid in peripheral arterial disease: effect on lipid pattern, disease severity, inflammation profile, and endothelial function. Clin Nutr. 2008 Apr;27(2):241-7. doi: 10.1016/j.clnu.2007.11.007. Epub 2008 Jan 31.

    PubMed 18237823

  • Al-Qaisi M, Kharbanda RK, Mittal TK, Donald AE. Measurement of endothelial function and its clinical utility for cardiovascular risk. Vasc Health Risk Manag. 2008;4(3):647-52. doi: 10.2147/vhrm.s2769.

    PubMed 18827914

  • Lane HA, Smith JC, Davies JS. Noninvasive assessment of preclinical atherosclerosis. Vasc Health Risk Manag. 2006;2(1):19-30. doi: 10.2147/vhrm.2006.2.1.19.

    PubMed 17319466

  • Simon A, Chironi G, Levenson J. Comparative performance of subclinical atherosclerosis tests in predicting coronary heart disease in asymptomatic individuals. Eur Heart J. 2007 Dec;28(24):2967-71. doi: 10.1093/eurheartj/ehm487. Epub 2007 Oct 29.

    PubMed 17967818

  • Wang X, Keith JC Jr, Struthers AD, Feuerstein GZ. Assessment of arterial stiffness, a translational medicine biomarker system for evaluation of vascular risk. Cardiovasc Ther. 2008 Fall;26(3):214-23. doi: 10.1111/j.1755-5922.2008.00051.x.

    PubMed 18786091

  • Cohn JN, Duprez DA, Grandits GA. Arterial elasticity as part of a comprehensive assessment of cardiovascular risk and drug treatment. Hypertension. 2005 Jul;46(1):217-20. doi: 10.1161/01.HYP.0000165686.50890.c3. Epub 2005 May 2.

    PubMed 15867132

  • Stamatelopoulos K, Karatzi K, Sidossis LS. Noninvasive methods for assessing early markers of atherosclerosis: the role of body composition and nutrition. Curr Opin Clin Nutr Metab Care. 2009 Sep;12(5):467-73. doi: 10.1097/MCO.0b013e32832f0d99.

    PubMed 19571744

  • Zahradka P, Guzman R, Weighell W, Wright B, Baldwin A, Louis S, et al. Increased consumption of legumes improves arterial stiffness in peripheral vascular disease independent of blood pressure, weight and serum cholesterol. Experimental Biology '09, April 18-22, New Orleans, LA 2009.

Questions about this trial

What is this clinical trial studying?

A study testing traditional canola oil, high oleic canola oil and soybean oil in people with Peripheral Arterial 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?

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 27 Mar 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.

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?

Acute study to identify the relative potency of fatty acid compositions on blood vessel function in healthy participants and individuals with peripheral arterial disease. (time frame: weekly testing for 5 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 NCT01250275, which also lists 36 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 27 Mar 2013.

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