Canola Oil Multi-Centre Intervention Trial II
- Conditions
- Cardiovascular DiseaseDiabetesMetabolic Syndrome
- Interventions
- Other: Western Type Diet - Common Dietary OilsOther: Regular Canola OilOther: High Oleic Canola Oil
- Registration Number
- NCT02029833
- Lead Sponsor
- University of Manitoba
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Western Type Diet - Common Dietary Oils Western Type Diet - Common Dietary Oils Ghee, Safflower oil, Coconut oil, \& flax oil Regular Canola Oil Regular Canola Oil 60% oleic acid High Oleic Canola Oil High Oleic Canola Oil 70% oleic acid
- Primary Outcome Measures
Name Time Method Abdominal imaging of visceral and subcutaneous abdominal fat 6 weeks Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity. Units (fat mass) measured are cm3 and lbs.
- Secondary Outcome Measures
Name Time Method Analysis of fatty acid ethanolamides and precursors 6 weeks Analysis of FAEs in the blood after consumption of treatment oils. UPLC-MS/MS will be used for FAE measurement.
Plasma glucose level 6 weeks Assessment of changes in fasting glucose levels after consumption of treatment oils. This measurement will be analyzed by Abbott Spectrum CCX Analyzer
Plasma C-reactive protein level 6 weeks Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits
Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels 6 weeks Analysis of blood levels after consumption of treatment oils. Abbott Spectrum CCX Analyzer utilizing enzymatic reagents will be used to analyzed these measurements.
Plasma insulin level 6 weeks Assessment of the change in insulin levels after consumption of treatment oils. This measurement will be analyzed by commercially available ELISA kits
Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism 6 weeks 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
Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism 6 weeks Assessment of levels of gene expression after consumption of treatment oils will be measured using real-time quantitative PCR
Lipocalin-2 6 weeks Fecal and serum lipocalin-2 will be analyzed for subgroup of participants using ELISA kit
Activity Monitoring 6 weeks 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
Plasma cytokines level 6 weeks Analysis of inflammatory marker levels after consumption of treatment oils will be conducted by ELISA kits
Plant sterols and precursors of cholesterol 6 weeks Analysis of plasma levels after consumption of treatment oils as indicators of cholesterol absorption and synthesis. These analysis will be conducted by gas chromatography
Proprotein convertase subtilisin/kexin type 9 (PCSK9) 6 weeks PCSK9 will be measured as a surrogate marker of bile acid synthesis via Ultra Performance Liquid Chromatography-MS/MS
Endothelial function 6 weeks Assessment of arterial wall resistance and arterial elasticity after consumption of treatment oils It will be assessed using flow mediated dilation
Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids 6 weeks 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
Lipopolysaccharide (LPS) 6 weeks Serum LPS will be analyzed for subgroup of participants using the LAL assay
Trial Locations
- Locations (4)
The Pennsylvania State University
🇺🇸University Park, Pennsylvania, United States
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, Canada