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Completed

NCT Number: NCT00927199

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

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High-Oleic Canola Oil

Dietary Supplement

Diets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid))

High-Oleic Canola/Flaxseed Oil Blend

Dietary Supplement

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))

Western Dietary Control

Dietary Supplement

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 outcomes

  1. Serum Lipids

    Time frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

  2. 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

  3. Intima-Medial Thickness by Carotid Ultrasound

    Time frame: Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase

  4. Energy Expenditure by Indirect Calorimetry

    Time frame: Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase

  5. Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)

    Time frame: Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase

  6. 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

  7. Plasma Fatty Acid Concentrations

    Time frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

Secondary outcomes

  1. Arterial Stiffness Index by Pulse Wave Analysis

    Time frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Agri-Food Research and Development Initiative
  • Canola Council of Canada
  • Flax Canada 2015 Inc.

Registry information

Official study title

Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 24, 2009
Registry last updated
Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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