Status:
COMPLETED
Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
St. Boniface Hospital
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40+ years
Phase:
NA
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 dieta...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01250275
Start Date
September 1 2011
End Date
February 1 2013
Last Update
March 27 2013
Active Locations (1)
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1
IH Asper Clinical Research Insitute, St. Boniface General Hospital
Winnipeg, Manitoba, Canada