IH Asper Clinical Research Insitute, St. Boniface General Hospital
Winnipeg, Manitoba, Canada
NCT Number: NCT01250275
The fatty acid composition of canola oil will have beneficial acute and chronic effects on vascular function in individuals with peripheral arterial disease.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy age-matched participants (acute phase of the study):
Inclusion criteria
, peripheral arterial disease participants (acute and chronic phases of the study):
Exclusion criteria
, healthy age-matched participants (acute phase of the study):
Exclusion criteria
, Peripheral arterial disease participants (acute and chronic phases of the study):
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
University of Manitoba
Other
Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease (PAD)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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