Clinical trial NCT01351012: Canola Oil Multicentre Intervention Trial
Official title: Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Canola oil
High oleic canola oil
Flax oil
ALA
DHA
Metabolic syndrome
Cardiovascular disease
Endothelial function
FADS1
Gut microbiome
Body composition
Psychosocial status
Cholesterol
Lipids
Lipoproteins
Inflammation
Lipid peroxidation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Penn State University
name: Laval University
First posted: 2011-05-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in endothelial function
timeFrame: 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:
measure: Change in ALA conversion to EPA/DHA
timeFrame: Blood samples will be collected at the end of each of the five 4-week treatment phases over a period of nine months.
measure: Change in body composition
timeFrame: Measurements will be done at the start and end of each of the five 4-week treatment phases over a period of nine months.
measure: Change in FADS 1 & 2 mRNA and protein expression
timeFrame: Blood samples will be collected at the end of each of the five 4-week treatment phases over a nine-month period.
measure: Change in psychosocial correlates
timeFrame: 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.
measure: Change in plasma lipids and lipoproteins, inflammatory cytokines and peroxidation biomarkers
timeFrame: Blood samples are collected at the start and end of each of the five 4-week treatment phases over a nine-month period.
measure: Blood Pressure
timeFrame: Over 3 years; at baseline and endpoint of each 4-week treatment phases
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Peter JH Jones, PhD
role: STUDY_CHAIR
affiliation: University of Toronto
name: David Jenkins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Penny Kris-Etherton, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Sheila West, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Benoit Lamarche, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.