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

This study has been completed.
Sponsor:
Collaborators:
Canola Council of Canada
Flax Canada 2015 Inc.
Agri-Food Research and Development Initiative
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00927199
First received: June 17, 2009
Last updated: January 31, 2013
Last verified: January 2013

June 17, 2009
January 31, 2013
September 2007
June 2008   (final data collection date for primary outcome measure)
  • Serum Lipids [ Time Frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Intima-Medial Thickness by Carotid Ultrasound [ Time Frame: Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase ] [ Designated as safety issue: No ]
  • Energy Expenditure by Indirect Calorimetry [ Time Frame: Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase ] [ Designated as safety issue: No ]
  • Body Composition by Dual Emission X-Ray Absorptiometry (DEXA) [ Time Frame: Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Plasma Fatty Acid Concentrations [ Time Frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00927199 on ClinicalTrials.gov Archive Site
Arterial Stiffness Index by Pulse Wave Analysis [ Time Frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of High-oleic Canola and Flaxseed Oils for Hypercholesterolemia and Cardiovascular Disease Risk Factors
Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Cardiovascular Disease
  • Dietary Supplement: High-Oleic Canola Oil
    Diets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid))
  • Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend
    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))
  • Dietary Supplement: Western Dietary Control
    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))
  • Experimental: High-Oleic Canola Oil
    Intervention: Dietary Supplement: High-Oleic Canola Oil
  • Experimental: High-Oleic Canola/Flaxseed Oil Blend
    Intervention: Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend
  • Active Comparator: Western Diet
    Intervention: Dietary Supplement: Western Dietary Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2008
June 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00927199
B2007:071
Yes
Peter J.H. Jones, PhD; Principal Investigator, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
University of Manitoba
  • Canola Council of Canada
  • Flax Canada 2015 Inc.
  • Agri-Food Research and Development Initiative
Principal Investigator: Peter JH Jones, PhD University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
University of Manitoba
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP