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

March 25, 2013 updated by: Dr. Carla Taylor, University of Manitoba

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • IH Asper Clinical Research Insitute, St. Boniface General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute Phase: traditional canola oil
Participants will receive banana bread containing traditional canola oil once weekly during the 5-week schedule
Other: 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.
Other: 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.
Active Comparator: Acute Phase: high oleic canola oil
Participants will receive banana bread containing high oleic canola oil once weekly during the 5-week schedule
Other: 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.
Active Comparator: Acute Phase: soybean oil
Participants will receive banana bread containing soybean oil once weekly during the 5-week schedule
Other: 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.
Active Comparator: Acute Phase: high linoleic safflower oil
Participants will receive banana bread containing high linoleic safflower oil once weekly during the 5-week schedule
Other: 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.
Active Comparator: Acute Phase: coconut oil
Participants will receive banana bread containing coconut oil once weekly during the 5-week schedule
Other: 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.
Experimental: 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
Other: 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.
Other: 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.
Active Comparator: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute study to identify the relative potency of fatty acid compositions on blood vessel function in healthy participants and individuals with peripheral arterial disease.
Time Frame: weekly testing for 5 weeks
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.
weekly testing for 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: baseline and at 8 weeks
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.
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.
Time Frame: baseline and at 8 weeks
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.
baseline and at 8 weeks
4. To assess compliance and tolerability through subjective feedback provided from participants during the chronic 8-week study.
Time Frame: baseline at at 8 weeks
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.
baseline at at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

St. Boniface Hospital

Investigators

  • Principal Investigator: Carla Taylor, PhD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 29, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

March 27, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2010:125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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