Clinical trial NCT01250275: Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease
Official title: Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease (PAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Canola Oil
Peripheral Arterial Disease
Peripheral Vascular Disease
PAD
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: St. Boniface Hospital
First posted: 2010-11-30
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: weekly testing for 5 weeks
Secondary outcomes:
measure: 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.
timeFrame: baseline and at 8 weeks
measure: To explore whether improvements in blood vessel function in the chronic 8-week study are also associated with improvements in cognitive function.
timeFrame: baseline and at 8 weeks
measure: 4. To assess compliance and tolerability through subjective feedback provided from participants during the chronic 8-week study.
timeFrame: baseline at at 8 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: IH Asper Clinical Research Insitute, St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Carla Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
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