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

NCT ID: NCT00927199

Last Updated: 2013-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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High-Oleic Canola Oil

Group Type EXPERIMENTAL

High-Oleic Canola Oil

Intervention Type 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

Group Type EXPERIMENTAL

High-Oleic Canola/Flaxseed Oil Blend

Intervention Type 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 Diet

Group Type ACTIVE_COMPARATOR

Western Dietary Control

Intervention Type 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))

Interventions

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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))

Intervention Type 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))

Intervention Type 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))

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canola Council of Canada

OTHER

Sponsor Role collaborator

Flax Canada 2015 Inc.

INDUSTRY

Sponsor Role collaborator

Agri-Food Research and Development Initiative

UNKNOWN

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Principal Investigators

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Peter JH Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals

Locations

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Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 21308420 (View on PubMed)

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.

Reference Type RESULT
PMID: 23221573 (View on PubMed)

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.

Reference Type RESULT
PMID: 22698766 (View on PubMed)

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.

Reference Type RESULT
PMID: 20875216 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25262934 (View on PubMed)

Other Identifiers

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B2007:071

Identifier Type: -

Identifier Source: org_study_id

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