Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease
NCT ID: NCT01250275
Last Updated: 2013-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2011-09-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Acute Phase: traditional canola oil
Participants will receive banana bread containing traditional canola oil once weekly during the 5-week schedule
traditional canola oil
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.
Acute Phase: high oleic canola oil
Participants will receive banana bread containing high oleic canola oil once weekly during the 5-week schedule
high oleic canola oil
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.
Acute Phase: soybean oil
Participants will receive banana bread containing soybean oil once weekly during the 5-week schedule
soybean oil
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.
Acute Phase: high linoleic safflower oil
Participants will receive banana bread containing high linoleic safflower oil once weekly during the 5-week schedule
high linoleic safflower oil
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.
Acute Phase: coconut oil
Participants will receive banana bread containing coconut oil once weekly during the 5-week schedule
coconut oil
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.
Chronic Phase: traditional canola oil
A total of 25 participants with peripheral arterial disease will be assigned foods containing traditional canola oil for a total of 8 weeks
traditional canola oil
Participants with peripheral arterial disease (n=25) will be randomized to daily consumption of food items prepared with traditional canola oil for eight weeks.
Chronic Phase: safflower oil
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
safflower oil
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
Interventions
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traditional canola oil
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 oil
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 oil
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 oil
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 oil
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 oil
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 oil
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
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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.
40 Years
ALL
Yes
Sponsors
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St. Boniface Hospital
OTHER
University of Manitoba
OTHER
Responsible Party
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Dr. Carla Taylor
Professor, Department of Human Nutritional Sciences
Principal Investigators
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Carla Taylor, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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IH Asper Clinical Research Insitute, St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Countries
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References
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Other Identifiers
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B2010:125
Identifier Type: -
Identifier Source: org_study_id
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