Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 125
- Locations
- 8
- Primary Endpoint
- Abdominal imaging of visceral and subcutaneous abdominal fat
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Outcomes
Primary Outcomes
Abdominal imaging of visceral and subcutaneous abdominal fat
Time Frame: 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 Outcomes
- Analysis of fatty acid ethanolamides and precursors(6 weeks)
- Plasma glucose level(6 weeks)
- Plasma C-reactive protein level(6 weeks)
- Total lipid profiles including total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglyceride, and free fatty acid levels(6 weeks)
- Plasma insulin level(6 weeks)
- Single nucleotide polymorphisms in candidate genes related to body composition and fatty acid and FAE metabolism(6 weeks)
- Gene expression of candidate genes related to body composition and fatty acid and FAE metabolism(6 weeks)
- Lipocalin-2(6 weeks)
- Activity Monitoring(6 weeks)
- Plasma cytokines level(6 weeks)
- Plant sterols and precursors of cholesterol(6 weeks)
- Proprotein convertase subtilisin/kexin type 9 (PCSK9)(6 weeks)
- Endothelial function(6 weeks)
- Fatty acid synthesis rates i.e. monounsaturated fatty acids and long chain polyunsaturated fatty acids(6 weeks)
- Lipopolysaccharide (LPS)(6 weeks)