Clinical trial NCT02029833: Canola Oil Multi-Centre Intervention Trial II
Official title: Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Diabetes
Metabolic Syndrome
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Penn State University
name: University of Toronto
name: Laval University
name: St. Boniface Hospital
name: University at Buffalo
name: Canola Council of Canada
name: Agriculture and Agri-Food Canada
First posted: 2014-01-08
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objectives of the study are to examine the health benefits of dietary canola oils on body composition, specifically on android fat, and weight management. COMIT II will also include analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body composition. Measurement of endothelial function, inflammatory, adiposity, and insulin sensitivity biomarkers will be done to determine the positive health impact of the changes in body composition achieved through canola oil consumption.

Detailed description: The proposed multi-center clinical trial would engage the same collaborative team that successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the L'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St. Michael's Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg, Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research program will proceed as a double blind, randomized crossover study consisting of three treatment phases of six weeks, each separated by a 6-week washout period. Participants will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical "Western diet" fat intake as a control treatment comprised largely of saturated fat with substantial levels of omega-6 linoleic acid, common to current North American intakes. Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and consumed at breakfast and supper. The clinical segment of COMIT II is expected to be completed by the mid to end of the second year, with sample analyses to be completed by the end of year three.

Eligibility criteria: Inclusion Criteria:

- Waist circumference ≥94 cm for men and ≥80 cm for women

Participants must meet at least one of the following secondary inclusion criteria:

* Fasting blood glucose of ≥ 5.6 mmol/L
* Triglycerides (TG) ≥1.7 mmol/L
* HDL cholesterol (HDL) \<1 mmol/L (males) or \<1.3 mmol/L (females)
* Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic).

Exclusion Criteria:

* Kidney, or liver disease, or unstable thyroid disease
* Diabetes mellitus
* Smokers
* Those consuming \>1 alcoholic beverage a day for women and \>2 for men.
* Any participant taking medication known to affect lipid metabolism or endothelial function

Primary outcomes:
measure: Abdominal imaging of visceral and subcutaneous abdominal fat
timeFrame: 6 weeks
Secondary outcomes:
measure: Analysis of fatty acid ethanolamides and precursors
timeFrame: 6 weeks
measure: Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels
timeFrame: 6 weeks
measure: Plasma insulin level
timeFrame: 6 weeks
measure: Plasma glucose level
timeFrame: 6 weeks
measure: Plasma C-reactive protein level
timeFrame: 6 weeks
measure: Plasma cytokines level
timeFrame: 6 weeks
measure: Plant sterols and precursors of cholesterol
timeFrame: 6 weeks
measure: Proprotein convertase subtilisin/kexin type 9 (PCSK9)
timeFrame: 6 weeks
measure: Endothelial function
timeFrame: 6 weeks
measure: Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids
timeFrame: 6 weeks
measure: Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism
timeFrame: 6 weeks
measure: Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism
timeFrame: 6 weeks
measure: Activity Monitoring
timeFrame: 6 weeks
measure: Lipocalin-2
timeFrame: 6 weeks
measure: Lipopolysaccharide (LPS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
city: Winnipeg
country: Canada
facility: St Boniface Hospital Research
state: Manitoba
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
state: Manitoba
city: Quebec City
country: Canada
facility: Institute of Nutrition and Functional Foods, Laval University
state: Quebec
Study officials:
affiliation: University of Manitoba
name: Peter Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammad SS, Eck P, Sihag J, Chen X, Connelly PW, Lamarche B, Couture P, Guay V, Maltais-Giguere J, West SG, Kris-Etherton PM, Bowen KJ, Jenkins DJA, Taylor CG, Perera D, Wilson A, Castillo S, Zahradka P, Jones PJH. Common Variants in Lipid Metabolism-Related Genes Associate with Fat Mass Changes in Response to Dietary Monounsaturated Fatty Acids in Adults with Abdominal Obesity. J Nutr. 2019 Oct 1;149(10):1749-1756. doi: 10.1093/jn/nxz136.
citation: Bowen KJ, Kris-Etherton PM, West SG, Fleming JA, Connelly PW, Lamarche B, Couture P, Jenkins DJA, Taylor CG, Zahradka P, Hammad SS, Sihag J, Chen X, Guay V, Maltais-Giguere J, Perera D, Wilson A, Juan SCS, Rempel J, Jones PJH. Diets Enriched with Conventional or High-Oleic Acid Canola Oils Lower Atherogenic Lipids and Lipoproteins Compared to a Diet with a Western Fatty Acid Profile in Adults with Central Adiposity. J Nutr. 2019 Mar 1;149(3):471-478. doi: 10.1093/jn/nxy307.