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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250275
• Other study ID #: B2010:125
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: March 25, 2013
• Start date: September 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
Canada	IH Asper Clinical Research Insitute, St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	St. Boniface General Hospital Research Centre

Country where clinical trial is conducted

Canada, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute study to identify the relative potency of fatty acid compositions on blood vessel function in healthy participants and individuals with peripheral arterial disease.	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	No
Secondary	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.	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	No
Secondary	To explore whether improvements in blood vessel function in the chronic 8-week study are also associated with improvements in cognitive function.	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	No
Secondary	4. To assess compliance and tolerability through subjective feedback provided from participants during the chronic 8-week study.	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	No

External Links

•   website posting of study on CCARM website