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

Phase 2

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: High-Oleic Canola Oil; Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend; Dietary Supplement: Western Dietary Control

• Registration Number: NCT00927199
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-24
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-Oleic Canola Oil	High-Oleic Canola Oil	-
High-Oleic Canola/Flaxseed Oil Blend	High-Oleic Canola/Flaxseed Oil Blend	-
Western Diet	Western Dietary Control	-

Primary Outcome Measures

Name	Time	Method
Serum Lipids	Baseline (Day 1,2) 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
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
Plasma Fatty Acid Concentrations	Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

Secondary Outcome Measures

Name	Time	Method
Arterial Stiffness Index by Pulse Wave Analysis	Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada