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

January 31, 2013 updated by: University of Manitoba

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 6C5
        • Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Lipids
Time Frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
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
Time Frame: Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Intima-Medial Thickness by Carotid Ultrasound
Time Frame: Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
Energy Expenditure by Indirect Calorimetry
Time Frame: Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)
Time Frame: Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
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
Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase
Plasma Fatty Acid Concentrations
Time Frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (ESTIMATE)

June 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2007:071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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