Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2014-09-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Canola oil
regular canola oil
Canola Oil
Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
High oleic acid canola oil
high stability/high oleic canola oil
High oleic acid canola oil
High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
Western diet oil combination
a typical "Western diet" fat intake comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA
Western diet oil combination
A typical "Western diet" fat intake as a control treatment, comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA, will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily
Interventions
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Canola Oil
Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
High oleic acid canola oil
High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
Western diet oil combination
A typical "Western diet" fat intake as a control treatment, comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA, will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily
Eligibility Criteria
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Inclusion Criteria
* Elevated triglycerides - ≥150 mg/dL and ≤ 400 mg/dL
* Reduced HDL - \< 40 mg/dL for men and \< 50 mg/dL for women
* Fasting glucose - ≥ 100 mg/dl and ≤ 126 mg/dL
* Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG \[Unmedicated participants - upper limit of Stage 1 Hypertension: systolic \< 160 and/or diastolic \<100 mm HG and participants must be free of end stage/target organ disease symptoms\] \[BP medicated participants: acceptable as long as individuals meet the specified blood pressure range of \<140/90 mmHg, and have been stable for at least 6 months\]
Exclusion Criteria
* Individuals with diabetes mellitus
* Smokers
* Individuals consuming \>14 alcoholic beverages per week
* Individuals taking lipid lowering medication (ex: cholestyramine, colestipol, niacin, cloribrate, gemfibrozil, probucol, HMG CoA reductase inhibitors) for at least the last 3 months
* Pregnancy or lactation
20 Years
65 Years
ALL
Yes
Sponsors
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Canola Council of Canada
OTHER
University of Manitoba
OTHER
Laval University
OTHER
Unity Health Toronto
OTHER
St. Boniface Hospital
OTHER
Penn State University
OTHER
Responsible Party
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Principal Investigators
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Penny M Kris-Etherton, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Locations
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Penn State University
University Park, Pennsylvania, United States
Countries
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Other Identifiers
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PKE COMIT II
Identifier Type: -
Identifier Source: org_study_id
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