Canola Oil Multicentre Intervention Trial

NCT ID: NCT01351012

Last Updated: 2014-02-19

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

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-04-30

Brief Summary

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The purpose of the study is to examine how the consumption of different dietary oil varieties affects a broad range of metabolic responses that are important in the development of cardiovascular diseases. This study will examine the relationship between dietary oil consumption and arterial function, blood fat content, and blood markers of cardiovascular disease risk. Additionally, the efficiency of the body in converting fat from dietary oils into other specific fat compounds with know health benefits will be examined. Also, the correlation between psychosocial parameters and vascular function will be studied.

Detailed Description

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Although consumption of omega-3 fatty acids favorably modulate circulating lipids and arterial health, there is confusion surrounding the specific health benefits of plant based alpha-linolenic acid (ALA) versus marine derived eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This research will examine the health benefits of ALA from consumption of diets rich in canola oil, novel monounsaturated fatty acid (MUFA) and DHA enriched canola oils, and flax oil compared with a control diet representative of North American diets rich in omega-6 and saturated fats. Treatment oils will be examined for potential influence on endothelial dysfunction, inflammation, oxidation, body composition, and plasma lipoprotein characterization. Furthermore, in an effort to elucidate the genetic factors that promote ALA conversion to EPA/DHA and strengthen the role of ALA in cardiovascular health, a major objective is to correlate common genetic variants in the fatty acid desaturase 1 (FADS1) and fatty acid desaturase 2 (FADS2) gene cluster with ALA conversion to EPA/DHA and n-3 fatty acid composition of serum phospholipids in response to consumption of the treatment oils. Besides, psychosocial predictors of vascular function will be investigated.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Corn and safflower oil

Group Type PLACEBO_COMPARATOR

Corn and safflower oil

Intervention Type OTHER

The oil (60 g/d/3000 kcal) is given in two daily fruit shakes for 4 weeks

Canola oil

Group Type ACTIVE_COMPARATOR

Canola oil

Intervention Type OTHER

The oil (60 g/d/3000 kcal providing 3.8 g ALA) is given in two daily fruit shakes for 4 weeks

High oleic acid canola oil

Group Type ACTIVE_COMPARATOR

High oleic acid canola oil

Intervention Type OTHER

The oil (60 g/d/3000 kcal providing 41.2 g oleic acid and 1.2 g ALA) is given in two daily fruit shakes for 4 weeks

DHA enriched high oleic acid canola oil

Group Type ACTIVE_COMPARATOR

DHA enriched high oleic acid canola oil

Intervention Type OTHER

The oil (60 g/d/3000 kcal providing 1.2 g of ALA and 3.6 g of DHA) is given in two daily fruit shakes for 4 weeks

Flax and safflower oil

Group Type ACTIVE_COMPARATOR

Flax and safflower oil

Intervention Type OTHER

The oil (60 g/d/3000 kcal providing 6.9 g of ALA) is given in two daily fruit shakes for 4 weeks

Interventions

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Corn and safflower oil

The oil (60 g/d/3000 kcal) is given in two daily fruit shakes for 4 weeks

Intervention Type OTHER

Canola oil

The oil (60 g/d/3000 kcal providing 3.8 g ALA) is given in two daily fruit shakes for 4 weeks

Intervention Type OTHER

High oleic acid canola oil

The oil (60 g/d/3000 kcal providing 41.2 g oleic acid and 1.2 g ALA) is given in two daily fruit shakes for 4 weeks

Intervention Type OTHER

DHA enriched high oleic acid canola oil

The oil (60 g/d/3000 kcal providing 1.2 g of ALA and 3.6 g of DHA) is given in two daily fruit shakes for 4 weeks

Intervention Type OTHER

Flax and safflower oil

The oil (60 g/d/3000 kcal providing 6.9 g of ALA) is given in two daily fruit shakes for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Waist circumference ≥94 cm (males) or ≥80 cm (females)

plus at least one of the following:

* Triglycerides ≥1.7 mmol/L
* High density lipoprotein (HDL) cholesterol \<1 mmol/L (males) or \<1.3 mmol/L (females)
* Low density lipoprotein (LDL) cholesterol ≥3.5 mmol/L
* Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
* Glucose ≥5.5 mmol/L

Exclusion Criteria

* Thyroid disease
* Diabetes mellitus
* Kidney disease
* Liver disease
* Smoking
* Heavy drinking
* Use of medication known to affect lipid metabolism during the last 3 months(cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Peter Jones

Director of the Richardson Centre for Functional Foods and Nutraceuticals

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter JH Jones, PhD

Role: STUDY_CHAIR

University of Manitoba

David Jenkins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Penny Kris-Etherton, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Sheila West, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Benoit Lamarche, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Liu X, Garban J, Jones PJ, Vanden Heuvel J, Lamarche B, Jenkins DJ, Connelly PW, Couture P, Pu S, Fleming JA, West SG, Kris-Etherton PM. Diets Low in Saturated Fat with Different Unsaturated Fatty Acid Profiles Similarly Increase Serum-Mediated Cholesterol Efflux from THP-1 Macrophages in a Population with or at Risk for Metabolic Syndrome: The Canola Oil Multicenter Intervention Trial. J Nutr. 2018 May 1;148(5):721-728. doi: 10.1093/jn/nxy040.

Reference Type DERIVED
PMID: 30053283 (View on PubMed)

Liu X, Kris-Etherton PM, West SG, Lamarche B, Jenkins DJ, Fleming JA, McCrea CE, Pu S, Couture P, Connelly PW, Jones PJ. Effects of canola and high-oleic-acid canola oils on abdominal fat mass in individuals with central obesity. Obesity (Silver Spring). 2016 Nov;24(11):2261-2268. doi: 10.1002/oby.21584.

Reference Type DERIVED
PMID: 27804268 (View on PubMed)

Jones PJ, MacKay DS, Senanayake VK, Pu S, Jenkins DJ, Connelly PW, Lamarche B, Couture P, Kris-Etherton PM, West SG, Liu X, Fleming JA, Hantgan RR, Rudel LL. High-oleic canola oil consumption enriches LDL particle cholesteryl oleate content and reduces LDL proteoglycan binding in humans. Atherosclerosis. 2015 Feb;238(2):231-8. doi: 10.1016/j.atherosclerosis.2014.12.010. Epub 2014 Dec 9.

Reference Type DERIVED
PMID: 25528432 (View on PubMed)

Baril-Gravel L, Labonte ME, Couture P, Vohl MC, Charest A, Guay V, Jenkins DA, Connelly PW, West S, Kris-Etherton PM, Jones PJ, Fleming JA, Lamarche B. Docosahexaenoic acid-enriched canola oil increases adiponectin concentrations: a randomized crossover controlled intervention trial. Nutr Metab Cardiovasc Dis. 2015 Jan;25(1):52-9. doi: 10.1016/j.numecd.2014.08.003. Epub 2014 Aug 20.

Reference Type DERIVED
PMID: 25240692 (View on PubMed)

Jones PJ, Senanayake VK, Pu S, Jenkins DJ, Connelly PW, Lamarche B, Couture P, Charest A, Baril-Gravel L, West SG, Liu X, Fleming JA, McCrea CE, Kris-Etherton PM. DHA-enriched high-oleic acid canola oil improves lipid profile and lowers predicted cardiovascular disease risk in the canola oil multicenter randomized controlled trial. Am J Clin Nutr. 2014 Jul;100(1):88-97. doi: 10.3945/ajcn.113.081133. Epub 2014 May 14.

Reference Type DERIVED
PMID: 24829493 (View on PubMed)

Senanayake VK, Pu S, Jenkins DA, Lamarche B, Kris-Etherton PM, West SG, Fleming JA, Liu X, McCrea CE, Jones PJ. Plasma fatty acid changes following consumption of dietary oils containing n-3, n-6, and n-9 fatty acids at different proportions: preliminary findings of the Canola Oil Multicenter Intervention Trial (COMIT). Trials. 2014 Apr 23;15:136. doi: 10.1186/1745-6215-15-136.

Reference Type DERIVED
PMID: 24754911 (View on PubMed)

Other Identifiers

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B2010:047

Identifier Type: -

Identifier Source: org_study_id

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