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

This study has been completed.
Sponsor:
Collaborator:
St. Boniface General Hospital Research Centre
Information provided by (Responsible Party):
Dr. Carla Taylor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01250275
First received: November 29, 2010
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Peripheral Arterial Disease
Other: traditional canola oil
Other: high oleic canola oil
Other: soybean oil
Other: high linoleic safflower oil
Other: coconut oil
Other: safflower oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease (PAD)

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 53
Study Start Date: September 2011
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250275

Locations
Canada, Manitoba
IH Asper Clinical Research Insitute, St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
St. Boniface General Hospital Research Centre
Investigators
Principal Investigator: Carla Taylor, PhD University of Manitoba
  More Information

Additional Information:
Publications:
Zahradka P, Guzman R, Weighell W, Wright B, Baldwin A, Louis S, et al. Increased consumption of legumes improves arterial stiffness in peripheral vascular disease independent of blood pressure, weight and serum cholesterol. Experimental Biology '09, April 18-22, New Orleans, LA 2009.

Responsible Party: Dr. Carla Taylor, Professor, Department of Human Nutritional Sciences, University of Manitoba
ClinicalTrials.gov Identifier: NCT01250275     History of Changes
Other Study ID Numbers: B2010:125
Study First Received: November 29, 2010
Last Updated: March 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Canola Oil
Peripheral Arterial Disease
Peripheral Vascular Disease
PAD

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014