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

University of Manitoba

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Other: safflower oil; Other: traditional canola oil; Other: high linoleic safflower oil; Other: soybean oil; Other: coconut oil; Other: high oleic canola oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01250275

B2010:125

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

53 participants in 7 patient groups

Acute Phase: traditional canola oil

Experimental group

Description:

Participants will receive banana bread containing traditional canola oil once weekly during the 5-week schedule

Treatment:

Other: traditional canola oil

Other: traditional canola oil

Acute Phase: high oleic canola oil

Active Comparator group

Description:

Participants will receive banana bread containing high oleic canola oil once weekly during the 5-week schedule

Treatment:

Other: high oleic canola oil

Acute Phase: soybean oil

Active Comparator group

Description:

Participants will receive banana bread containing soybean oil once weekly during the 5-week schedule

Treatment:

Other: soybean oil

Acute Phase: high linoleic safflower oil

Active Comparator group

Description:

Participants will receive banana bread containing high linoleic safflower oil once weekly during the 5-week schedule

Treatment:

Other: high linoleic safflower oil

Acute Phase: coconut oil

Active Comparator group

Description:

Participants will receive banana bread containing coconut oil once weekly during the 5-week schedule

Treatment:

Other: coconut oil

Chronic Phase: traditional canola oil

Experimental group

Description:

A total of 25 participants with peripheral arterial disease will be assigned foods containing traditional canola oil for a total of 8 weeks

Treatment:

Other: traditional canola oil

Other: traditional canola oil

Chronic Phase: safflower oil

Active Comparator group

Description:

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

Treatment:

Other: safflower oil