Efficacy of High-oleic Canola and Flaxseed Oils for Hypercholesterolemia and Cardiovascular Disease Risk Factors

Cardiovascular Disease Clinical Trial

Official title:

Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927199
• Other study ID #: B2007:071
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2009
• Last updated: January 31, 2013
• Start date: September 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2013
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypercholesterolemia

Intervention

Dietary Supplement:
• High-Oleic Canola Oil
Diets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid))
• High-Oleic Canola/Flaxseed Oil Blend
Diets contained 35% energy as fat; of which 70% was provided by a 1:1 blend of high-oleic canola oil and flaxseed oil (high in monounsaturated fat (oleic acid) and omega-3 polyunsaturated fat (alpha-linolenic acid))
• Western Dietary Control
Diets contained 35% energy as fat; of which 70% was provided by a blend of oils typical to the Western diet (high in saturated fat and omega-6 polyunsaturated fat (linoleic acid))

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
University of Manitoba	Agri-Food Research and Development Initiative, Canola Council of Canada, Flax Canada 2015 Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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 — View Citation

Gillingham LG, Harding SV, Rideout TC, Yurkova N, Cunnane SC, Eck PK, Jones PJ. Dietary oils and FADS1-FADS2 genetic variants modulate [13C]a-linolenic acid metabolism and plasma fatty acid composition. Am J Clin Nutr. 2013 Jan;97(1):195-207. doi: 10.3945 — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Lipids		Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase	No
Primary	Inflammatory Biomarkers: C-Reactive Protein, Interleukin-6, sE-Selectin, sVCAM-1, sICAM-1		Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase	No
Primary	Intima-Medial Thickness by Carotid Ultrasound		Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase	No
Primary	Energy Expenditure by Indirect Calorimetry		Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase	No
Primary	Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)		Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase	No
Primary	Oxidation and Conversion of U-13C-Alpha Linolenic Acid		Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase	No
Primary	Plasma Fatty Acid Concentrations		Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase	No
Secondary	Arterial Stiffness Index by Pulse Wave Analysis		Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase	No

External Links

•   Richardson Centre for Functional Foods and Nutraceuticals - website home page