Clinical trial NCT00927199: Efficacy of High-oleic Canola and Flaxseed Oils for Hypercholesterolemia and Cardiovascular Disease Risk Factors
Official title: Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Keywords: High-Oleic Canola Oil
Flaxseed Oil
Monounsaturated Fatty Acids
Polyunsaturated Fatty Acids
Alpha Linolenic Acid
Cardiovascular
Hypercholesterolemia
Lipids
Inflammation
Metabolism
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canola Council of Canada
name: Flax Canada 2015 Inc.
name: Agri-Food Research and Development Initiative
First posted: 2009-06-24
Enrollment: 36
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 this study is to assess the efficacy of high-oleic canola oil and a high-oleic canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic patients. Furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid contained in high-oleic canola oil and flaxseed oil will be investigated.


Eligibility criteria: Inclusion Criteria:

* Fasting serum LDL-Cholesterol \>3.0 mmol/L
* Body mass index (BMI) between 22-36 kg/m2

Exclusion Criteria:

* smoking
* use of lipid lowering therapy
* documented cardiovascular/atherosclerotic disease
* inflammatory disease
* diabetes
* uncontrolled hypertension
* kidney disease
* other systemic diseases
* cancer
* chronic alcohol consumption (\> 2 servings/day)
* excessive exercise expenditure (\> 4000 kcal/week)

Primary outcomes:
measure: Serum Lipids
timeFrame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
measure: Inflammatory Biomarkers: C-Reactive Protein, Interleukin-6, sE-Selectin, sVCAM-1, sICAM-1
timeFrame: Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
measure: Intima-Medial Thickness by Carotid Ultrasound
timeFrame: Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
measure: Energy Expenditure by Indirect Calorimetry
timeFrame: Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
measure: Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)
timeFrame: Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
measure: Oxidation and Conversion of U-13C-Alpha Linolenic Acid
timeFrame: Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase
measure: Plasma Fatty Acid Concentrations
timeFrame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Secondary outcomes:
measure: Arterial Stiffness Index by Pulse Wave Analysis
timeFrame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
name: Peter JH Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillingham LG, Harris-Janz S, Jones PJ. Dietary monounsaturated fatty acids are protective against metabolic syndrome and cardiovascular disease risk factors. Lipids. 2011 Mar;46(3):209-28. doi: 10.1007/s11745-010-3524-y. Epub 2011 Feb 10.
citation: Gillingham LG, Harding SV, Rideout TC, Yurkova N, Cunnane SC, Eck PK, Jones PJ. Dietary oils and FADS1-FADS2 genetic variants modulate [13C]alpha-linolenic acid metabolism and plasma fatty acid composition. Am J Clin Nutr. 2013 Jan;97(1):195-207. doi: 10.3945/ajcn.112.043117. Epub 2012 Dec 5.
citation: Gillingham LG, Robinson KS, Jones PJ. Effect of high-oleic canola and flaxseed oils on energy expenditure and body composition in hypercholesterolemic subjects. Metabolism. 2012 Nov;61(11):1598-605. doi: 10.1016/j.metabol.2012.04.016. Epub 2012 Jun 12.
citation: Gillingham LG, Gustafson JA, Han SY, Jassal DS, Jones PJ. High-oleic rapeseed (canola) and flaxseed oils modulate serum lipids and inflammatory biomarkers in hypercholesterolaemic subjects. Br J Nutr. 2011 Feb;105(3):417-27. doi: 10.1017/S0007114510003697. Epub 2010 Sep 29.
citation: Jones PJ, Lin L, Gillingham LG, Yang H, Omar JM. Modulation of plasma N-acylethanolamine levels and physiological parameters by dietary fatty acid composition in humans. J Lipid Res. 2014 Dec;55(12):2655-64. doi: 10.1194/jlr.P051235. Epub 2014 Sep 28.