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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

November 29, 2010
March 25, 2013
September 2011
December 2012   (final data collection date for primary outcome measure)
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.
Acute study to identify the relative potency of fatty acid compositions on blood vessel function in healthy participants and individuals with PAD [ Time Frame: weekly testing for 5 weeks ] [ Designated as safety issue: No ]
Participants (n=20,10 individuals with PAD and 10 healthy volunteers) will attend 5 weekly visits to receive one test meal in the form of a shake containing various oils. Assessments for vascular responsiveness at each visit (before consumption and twice within a 4-hour period) include:endothelial function, arterial stiffness, and advanced glycation endproducts. Blood samples will be collected to monitor changes in plasma triglycerides, glucose, insulin and markers of oxidative stress, inflammation, metabolism, and plasma fatty acid composition.
Complete list of historical versions of study NCT01250275 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 PAD. [ Time Frame: baseline and at 8 weeks ] [ Designated as safety issue: No ]
    Participants (n=50, 25/group) with PAD will be randomly assigned to receive a daily meal containing traditional canola oil or safflower oil. Assessments of vascular function, cognitive function, retinal function, blood lipid profile, glycated hemoglobin, biomarkers of vascular function, inflammation and metabolism, advanced glycation endproducts, and anthropometrics will be completed at baseline and at 8 weeks. A FFQ will be completed at baseline and a 3-day food record will be completed at the beginning and toward the end of the study.
  • 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 PAD will be randomly assigned to receive a daily meal containing traditional canola oil or safflower oil. 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 PAD will be randomly assigned to receive a daily meal containing traditional canola oil or safflower oil. Compliance and tolerability with food consumption (including side effects) will be assessed from participants' experiences throughout the 8-week study schedule.
Not Provided
Not Provided
 
Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Peripheral Arterial Disease
  • 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: 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • Experimental: Acute Phase: traditional canola oil
    Participants will receive banana bread containing traditional canola oil once weekly during the 5-week schedule
    Intervention: Other: 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
    Intervention: Other: 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
    Intervention: Other: 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
    Intervention: Other: 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
    Intervention: Other: 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
    Intervention: Other: traditional canola oil
  • 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
    Intervention: Other: safflower oil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
February 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01250275
B2010:125
No
Dr. Carla Taylor, University of Manitoba
University of Manitoba
St. Boniface General Hospital Research Centre
Principal Investigator: Carla Taylor, PhD University of Manitoba
University of Manitoba
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP