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

NCT00927199 | Completed Phase 2 DMC

• 1 other identifier: B2007:071
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

High-Oleic Canola Oil; Flaxseed Oil; Monounsaturated Fatty Acids; Polyunsaturated Fatty Acids; Alpha Linolenic Acid; Cardiovascular; Hypercholesterolemia; Lipids; Inflammation; Metabolism

Outcome Measures

Primary Outcomes (7)

• Serum Lipids

  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

  Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

• Intima-Medial Thickness by Carotid Ultrasound

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

• Energy Expenditure by Indirect Calorimetry

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

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

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

• Oxidation and Conversion of U-13C-Alpha Linolenic Acid

  Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase

• Plasma Fatty Acid Concentrations

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

Secondary Outcomes (1)

• Arterial Stiffness Index by Pulse Wave Analysis

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

Study Arms (3)

High-Oleic Canola Oil

EXPERIMENTAL

Dietary Supplement: High-Oleic Canola Oil

High-Oleic Canola/Flaxseed Oil Blend

EXPERIMENTAL

Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend

Western Diet

ACTIVE COMPARATOR

Dietary Supplement: Western Dietary Control

Interventions

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 Oil

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))

High-Oleic Canola/Flaxseed Oil Blend

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))

Western Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fasting serum LDL-Cholesterol \>3.0 mmol/L
• Body mass index (BMI) between 22-36 kg/m2

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead
• Canola Council of Canada: collaborator
• Flax Canada 2015 Inc.: collaborator
• Agri-Food Research and Development Initiative: collaborator

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Related Publications (5)

• 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.

  PMID: 21308420 BACKGROUND

• 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.

  PMID: 23221573 RESULT

• 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.

  PMID: 22698766 RESULT

• 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.

  PMID: 20875216 RESULT

• 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.

  PMID: 25262934 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Inflammation

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter JH Jones, PhD

  University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 24, 2009
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

CA (1)