search
Back to results

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

Primary Purpose

Cardiovascular Disease

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
High-Oleic Canola Oil
High-Oleic Canola/Flaxseed Oil Blend
Western Dietary Control
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring High-Oleic Canola Oil, Flaxseed Oil, Monounsaturated Fatty Acids, Polyunsaturated Fatty Acids, Alpha Linolenic Acid, Cardiovascular, Hypercholesterolemia, Lipids, Inflammation, Metabolism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

High-Oleic Canola Oil

High-Oleic Canola/Flaxseed Oil Blend

Western Diet

Arm Description

Outcomes

Primary Outcome Measures

Serum Lipids
Inflammatory Biomarkers: C-Reactive Protein, Interleukin-6, sE-Selectin, sVCAM-1, sICAM-1
Intima-Medial Thickness by Carotid Ultrasound
Energy Expenditure by Indirect Calorimetry
Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)
Oxidation and Conversion of U-13C-Alpha Linolenic Acid
Plasma Fatty Acid Concentrations

Secondary Outcome Measures

Arterial Stiffness Index by Pulse Wave Analysis

Full Information

First Posted
June 17, 2009
Last Updated
January 31, 2013
Sponsor
University of Manitoba
Collaborators
Canola Council of Canada, Flax Canada 2015 Inc., Agri-Food Research and Development Initiative
search

1. Study Identification

Unique Protocol Identification Number
NCT00927199
Brief Title
Efficacy of High-oleic Canola and Flaxseed Oils for Hypercholesterolemia and Cardiovascular Disease Risk Factors
Official Title
Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
Canola Council of Canada, Flax Canada 2015 Inc., Agri-Food Research and Development Initiative

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease
Keywords
High-Oleic Canola Oil, Flaxseed Oil, Monounsaturated Fatty Acids, Polyunsaturated Fatty Acids, Alpha Linolenic Acid, Cardiovascular, Hypercholesterolemia, Lipids, Inflammation, Metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Oleic Canola Oil
Arm Type
Experimental
Arm Title
High-Oleic Canola/Flaxseed Oil Blend
Arm Type
Experimental
Arm Title
Western Diet
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
High-Oleic Canola Oil
Intervention Description
Diets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid))
Intervention Type
Dietary Supplement
Intervention Name(s)
High-Oleic Canola/Flaxseed Oil Blend
Intervention Description
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))
Intervention Type
Dietary Supplement
Intervention Name(s)
Western Dietary Control
Intervention Description
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))
Primary Outcome Measure Information:
Title
Serum Lipids
Time Frame
Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Title
Inflammatory Biomarkers: C-Reactive Protein, Interleukin-6, sE-Selectin, sVCAM-1, sICAM-1
Time Frame
Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Title
Intima-Medial Thickness by Carotid Ultrasound
Time Frame
Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
Title
Energy Expenditure by Indirect Calorimetry
Time Frame
Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
Title
Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)
Time Frame
Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
Title
Oxidation and Conversion of U-13C-Alpha Linolenic Acid
Time Frame
Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase
Title
Plasma Fatty Acid Concentrations
Time Frame
Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Secondary Outcome Measure Information:
Title
Arterial Stiffness Index by Pulse Wave Analysis
Time Frame
Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter JH Jones, PhD
Organizational Affiliation
University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 6C5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21308420
Citation
Gillingham LG, Harris-Janz S, Jones PJ. Dietary monounsaturated fatty acids are protective against metabolic syndrome and cardiovascular disease risk factors. Lipids. 2011 Mar;46(3):209-28. doi: 10.1007/s11745-010-3524-y. Epub 2011 Feb 10.
Results Reference
background
PubMed Identifier
23221573
Citation
Gillingham LG, Harding SV, Rideout TC, Yurkova N, Cunnane SC, Eck PK, Jones PJ. Dietary oils and FADS1-FADS2 genetic variants modulate [13C]alpha-linolenic acid metabolism and plasma fatty acid composition. Am J Clin Nutr. 2013 Jan;97(1):195-207. doi: 10.3945/ajcn.112.043117. Epub 2012 Dec 5.
Results Reference
result
PubMed Identifier
22698766
Citation
Gillingham LG, Robinson KS, Jones PJ. Effect of high-oleic canola and flaxseed oils on energy expenditure and body composition in hypercholesterolemic subjects. Metabolism. 2012 Nov;61(11):1598-605. doi: 10.1016/j.metabol.2012.04.016. Epub 2012 Jun 12.
Results Reference
result
PubMed Identifier
20875216
Citation
Gillingham LG, Gustafson JA, Han SY, Jassal DS, Jones PJ. High-oleic rapeseed (canola) and flaxseed oils modulate serum lipids and inflammatory biomarkers in hypercholesterolaemic subjects. Br J Nutr. 2011 Feb;105(3):417-27. doi: 10.1017/S0007114510003697. Epub 2010 Sep 29.
Results Reference
result
PubMed Identifier
25262934
Citation
Jones PJ, Lin L, Gillingham LG, Yang H, Omar JM. Modulation of plasma N-acylethanolamine levels and physiological parameters by dietary fatty acid composition in humans. J Lipid Res. 2014 Dec;55(12):2655-64. doi: 10.1194/jlr.P051235. Epub 2014 Sep 28.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs