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

NCT01250275 | Completed

• 1 other identifier: B2010:125
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Arterial Disease

Keywords

Canola Oil; Peripheral Arterial Disease; Peripheral Vascular Disease; PAD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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.

  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.

  baseline and at 8 weeks

• 4. To assess compliance and tolerability through subjective feedback provided from participants during the chronic 8-week study.

  baseline at at 8 weeks

Study Arms (7)

Acute Phase: traditional canola oil

EXPERIMENTAL

Participants will receive banana bread containing traditional canola oil once weekly during the 5-week schedule

Other: traditional canola oil

Acute Phase: high oleic canola oil

ACTIVE COMPARATOR

Participants will receive banana bread containing high oleic canola oil once weekly during the 5-week schedule

Other: high oleic canola oil

Acute Phase: soybean oil

ACTIVE COMPARATOR

Participants will receive banana bread containing soybean oil once weekly during the 5-week schedule

Other: soybean oil

Acute Phase: high linoleic safflower oil

ACTIVE COMPARATOR

Participants will receive banana bread containing high linoleic safflower oil once weekly during the 5-week schedule

Other: high linoleic safflower oil

Acute Phase: coconut oil

ACTIVE COMPARATOR

Participants will receive banana bread containing coconut oil once weekly during the 5-week schedule

Other: coconut oil

Chronic Phase: traditional canola oil

EXPERIMENTAL

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

Chronic Phase: safflower oil

ACTIVE COMPARATOR

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

Interventions

traditional canola oil OTHER

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.

Acute Phase: traditional canola oil

high oleic canola oil OTHER

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.

Acute Phase: high oleic canola oil

soybean oil OTHER

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.

Acute Phase: soybean oil

high linoleic safflower oil OTHER

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.

Acute Phase: high linoleic safflower oil

coconut oil OTHER

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.

Acute Phase: coconut oil

safflower oil OTHER

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

Chronic Phase: safflower oil

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• University of Manitoba: lead
• St. Boniface Hospital: collaborator

Study Sites (1)

IH Asper Clinical Research Insitute, St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

Related Publications (36)

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MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Interventions

Soybean Oil; Coconut Oil; Safflower Oil

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Carla Taylor, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Human Nutritional Sciences

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: November 30, 2010
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: March 27, 2013

Record last verified: 2013-03

Locations

CA (1)