Efficacy of High-oleic Canola and Flaxseed Oils for Hypercholesterolemia and Cardiovascular Disease Risk Factors

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of high-oleic canola oil and a high-oleic canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic patients. Furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid contained in high-oleic canola oil and flaxseed oil will be investigated.

Official Title
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Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: High-Oleic Canola Oil
* Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend
* Dietary Supplement: Western Dietary Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting serum LDL-Cholesterol >3.0 mmol/L Body mass index (BMI) between 22-36 kg/m2 Exclusion Criteria: smoking use of lipid lowering therapy documented cardiovascular/atherosclerotic disease inflammatory disease diabetes uncontrolled hypertension kidney disease other systemic diseases cancer chronic alcohol consumption (> 2 servings/day) excessive exercise expenditure (> 4000 kcal/week)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Oleic Canola Oil<br> | Dietary Supplement: High-Oleic Canola Oil<br>* Diets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid))<br>|
| Experimental: High-Oleic Canola/Flaxseed Oil Blend<br> | Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend<br>* Diets contained 35% energy as fat; of which 70% was provided by a 1:1 blend of high-oleic canola oil and flaxseed oil (high in monounsaturated fat (oleic acid) and omega-3 polyunsaturated fat (alpha-linolenic acid))<br>|
| Active Comparator: Western Diet<br> | Dietary Supplement: Western Dietary Control<br>* Diets contained 35% energy as fat; of which 70% was provided by a blend of oils typical to the Western diet (high in saturated fat and omega-6 polyunsaturated fat (linoleic acid))<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Lipids |  | Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase | 
| Inflammatory Biomarkers: C-Reactive Protein, Interleukin-6, sE-Selectin, sVCAM-1, sICAM-1 |  | Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase | 
| Intima-Medial Thickness by Carotid Ultrasound |  | Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase | 
| Energy Expenditure by Indirect Calorimetry |  | Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase | 
| Body Composition by Dual Emission X-Ray Absorptiometry (DEXA) |  | Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase | 
| Oxidation and Conversion of U-13C-Alpha Linolenic Acid |  | Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase | 
| Plasma Fatty Acid Concentrations |  | Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Stiffness Index by Pulse Wave Analysis |  | Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-Oleic Canola Oil, Flaxseed Oil, Monounsaturated Fatty Acids, Polyunsaturated Fatty Acids, Alpha Linolenic Acid, Cardiovascular, Hypercholesterolemia, Lipids, Inflammation, Metabolism