Canola Oil Multi-Centre Intervention Trial II

Diabetes Clinical Trial

— COMIT2  

Official title:

Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029833
• Other study ID #: B2013:137
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: November 2016

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Regular Canola Oil

• High Oleic Canola Oil

• Western Type Diet - Common Dietary Oils

Locations

Country	Name	City	State
Canada	Institute of Nutrition and Functional Foods, Laval University	Quebec City	Quebec
Canada	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	Winnipeg	Manitoba
Canada	St Boniface Hospital Research	Winnipeg	Manitoba
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (8)

Lead Sponsor	Collaborator
University of Manitoba	Agriculture and Agri-Food Canada, Canola Council of Canada, Laval University, Penn State University, St. Boniface Hospital, University at Buffalo, University of Toronto

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal imaging of visceral and subcutaneous abdominal fat	Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.	6 weeks
Secondary	Analysis of fatty acid ethanolamides and precursors	Analysis of FAEs in the blood after consumption of treatment oils. UPLC-MS/MS will be used for FAE measurement.	6 weeks
Secondary	Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels	Analysis of blood levels after consumption of treatment oils. Abbott Spectrum CCX Analyzer utilizing enzymatic reagents will be used to analyzed these measurements.	6 weeks
Secondary	Plasma insulin level	Assessment of the change in insulin levels after consumption of treatment oils. This measurement will be analyzed by commercially available ELISA kits	6 weeks
Secondary	Plasma glucose level	Assessment of changes in fasting glucose levels after consumption of treatment oils. This measurement will be analyzed by Abbott Spectrum CCX Analyzer	6 weeks
Secondary	Plasma C-reactive protein level	Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits	6 weeks
Secondary	Plasma cytokines level	Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits	6 weeks
Secondary	Plant sterols and precursors of cholesterol	Analysis of plasma levels after consumption of treatment oils as indicators of cholesterol absorption and synthesis. These analysis will be conducted by gas chromatography	6 weeks
Secondary	Proprotein convertase subtilisin/kexin type 9 (PCSK9)	PCSK9 will be measured as a surrogate marker of bile acid synthesis via Ultra Performance Liquid Chromatography-MS/MS	6 weeks
Secondary	Endothelial function	Assessment of arterial wall resistance and arterial elasticity after consumption of treatment oils It will be assessed using flow mediated dilation	6 weeks
Secondary	Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids	Heavy water enrichment of each fatty acid methyl ester after consumption of treatment oils will be measured using a gas chromatography with combustion isotope-ratio mass spectrometry	6 weeks
Secondary	Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism	Assessment of the potential influence of each SNP in an individual's response to consumption of treatment oils will be conducted using 7500 Fast Real-Time PCR System	6 weeks
Secondary	Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism	Assessment of levels of gene expression after consumption of treatment oils will be measured using real-time quantitative PCR	6 weeks
Secondary	Activity Monitoring	Assessment of 24 hour physical activity including steps taken, raw acceleration, activity counts, energy expenditures, physical activity intensity, body position, and sleep/wake measurements after consumption of treatment oils will be measured using ActiGraph GT3X+ activity monitor	6 weeks
Secondary	Lipocalin-2	Fecal and serum lipocalin-2 will be analyzed for subgroup of participants using ELISA kit	6 weeks
Secondary	Lipopolysaccharide (LPS)	Serum LPS will be analyzed for subgroup of participants using the LAL assay	6 weeks