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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927199

Enrollment

Registered

2009-06-24

Start date

2007-09-30

Completion date

2008-06-30

Last updated

2013-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

High-Oleic Canola Oil, Flaxseed Oil, Monounsaturated Fatty Acids, Polyunsaturated Fatty Acids, Alpha Linolenic Acid, Cardiovascular, Hypercholesterolemia, Lipids, Inflammation, Metabolism

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.

Interventions

DIETARY_SUPPLEMENTHigh-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))

DIETARY_SUPPLEMENTHigh-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))

DIETARY_SUPPLEMENTWestern 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))

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Plasma Fatty Acid Concentrations	Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)	Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
Serum Lipids	Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
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
Intima-Medial Thickness by Carotid Ultrasound	Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
Energy Expenditure by Indirect Calorimetry	Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
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

Secondary

Measure	Time frame
Arterial Stiffness Index by Pulse Wave Analysis	Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026