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
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Dietary Supplement: High-Oleic Canola Oil
Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend
Dietary Supplement: Western Dietary Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: September 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-Oleic Canola Oil 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))
Experimental: High-Oleic Canola/Flaxseed Oil Blend 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))
Active Comparator: Western Diet 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))

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927199

Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, Canada, R3T 6C5
Sponsors and Collaborators
University of Manitoba
Canola Council of Canada
Flax Canada 2015 Inc.
Agri-Food Research and Development Initiative
Investigators
Principal Investigator: Peter JH Jones, PhD University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Peter J.H. Jones, PhD; Principal Investigator, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
ClinicalTrials.gov Identifier: NCT00927199     History of Changes
Other Study ID Numbers: B2007:071
Study First Received: June 17, 2009
Last Updated: January 31, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
High-Oleic Canola Oil
Flaxseed Oil
Monounsaturated Fatty Acids
Polyunsaturated Fatty Acids
Alpha Linolenic Acid
Cardiovascular
Hypercholesterolemia
Lipids
Inflammation
Metabolism

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014