NCT01351012

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

1.5 years

First QC Date

March 14, 2011

Last Update Submit

February 18, 2014

Conditions

Metabolic Syndrome

Keywords

Canola oilHigh oleic canola oilFlax oilALADHAMetabolic syndromeCardiovascular diseaseEndothelial functionFADS1Gut microbiomeBody compositionPsychosocial statusCholesterolLipidsLipoproteinsInflammationLipid peroxidation

Outcome Measures

Primary Outcomes (1)

  • Change in endothelial function

    Non-invasive peripheral arterial tonometry (EndoPAT) is used to assess endothelial function.

    Endothelial function will be measured at baseline and at the end of each of the five 4-week treatment phases over a period of nine months.

Secondary Outcomes (6)

  • Change in ALA conversion to EPA/DHA

    Blood samples will be collected at the end of each of the five 4-week treatment phases over a period of nine months.

  • Change in body composition

    Measurements will be done at the start and end of each of the five 4-week treatment phases over a period of nine months.

  • Change in FADS 1 & 2 mRNA and protein expression

    Blood samples will be collected at the end of each of the five 4-week treatment phases over a nine-month period.

  • Change in psychosocial correlates

    Measurements are done at baseline, at the start of the fifth treatment phase and at the end of each of the five 4-week treatment phases.

  • Change in plasma lipids and lipoproteins, inflammatory cytokines and peroxidation biomarkers

    Blood samples are collected at the start and end of each of the five 4-week treatment phases over a nine-month period.

  • +1 more secondary outcomes

Study Arms (5)

Corn and safflower oil

PLACEBO COMPARATOR
Other: Corn and safflower oil

Canola oil

ACTIVE COMPARATOR
Other: Canola oil

High oleic acid canola oil

ACTIVE COMPARATOR
Other: High oleic acid canola oil

DHA enriched high oleic acid canola oil

ACTIVE COMPARATOR
Other: DHA enriched high oleic acid canola oil

Flax and safflower oil

ACTIVE COMPARATOR
Other: Flax and safflower oil

Interventions

Corn and safflower oilOTHER

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

Corn and safflower oil
Canola oilOTHER

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

Canola oil
High oleic acid canola oilOTHER

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

High oleic acid canola oil
DHA enriched high oleic acid canola oilOTHER

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

DHA enriched high oleic acid canola oil
Flax and safflower oilOTHER

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

Flax and safflower oil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (6)

  • 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.

    PMID: 30053283DERIVED

  • 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.

    PMID: 27804268DERIVED

  • 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.

    PMID: 25528432DERIVED

  • 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.

    PMID: 25240692DERIVED

  • 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.

    PMID: 24829493DERIVED

  • 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.

    PMID: 24754911DERIVED

MeSH Terms

Conditions

Metabolic SyndromeCardiovascular DiseasesInflammation

Interventions

Safflower OilRapeseed OilLinseed Oil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Peter JH Jones, PhD

    University of Manitoba

    STUDY CHAIR

  • David Jenkins, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Penny Kris-Etherton, PhD, RD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Sheila West, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Benoit Lamarche, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Richardson Centre for Functional Foods and Nutraceuticals

Study Record Dates

First Submitted

March 14, 2011

First Posted

May 10, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

CA(1)