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.
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
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
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.
- Conditions
- Peripheral Arterial Disease
- 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 group | Role | What they receive |
|---|---|---|
| Acute Phase: traditional canola oil | Experimental | Participants 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 oil | Active comparator | Participants 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 oil | Active comparator | Participants will receive banana bread containing soybean oil once weekly during the 5-week schedule Receives: Other: soybean oil |
| Acute Phase: high linoleic safflower oil | Active comparator | Participants 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 oil | Active comparator | Participants will receive banana bread containing coconut oil once weekly during the 5-week schedule Receives: Other: coconut oil |
| Chronic Phase: traditional canola oil | Experimental | A 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 oil | Active comparator | A 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.
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)
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
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
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.
- First posted30 Nov 2010 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- St. Boniface Hospital
- 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
- 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 17904932Toth 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 19891944Poels 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 17272780Waldstein 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 18025297Aslam 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 19864983Mukherjee 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 19860299Carrero 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 15930443Schiano 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 18237823Al-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 18827914Lane 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 17319466Simon 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 17967818Wang 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 18786091Cohn 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 15867132Stamatelopoulos 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 19571744Zahradka 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.