Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Serum Lipids
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fasting serum LDL-Cholesterol >3.0 mmol/L
- •Body mass index (BMI) between 22-36 kg/m2
Exclusion Criteria
- •use of lipid lowering therapy
- •documented cardiovascular/atherosclerotic disease
- •inflammatory disease
- •uncontrolled hypertension
- •kidney disease
- •other systemic diseases
- •chronic alcohol consumption (> 2 servings/day)
- •excessive exercise expenditure (> 4000 kcal/week)
Outcomes
Primary Outcomes
Serum Lipids
Time Frame: 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
Time Frame: Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Intima-Medial Thickness by Carotid Ultrasound
Time Frame: Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
Energy Expenditure by Indirect Calorimetry
Time Frame: Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)
Time Frame: Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
Oxidation and Conversion of U-13C-Alpha Linolenic Acid
Time Frame: Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase
Plasma Fatty Acid Concentrations
Time Frame: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Secondary Outcomes
- Arterial Stiffness Index by Pulse Wave Analysis(Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase)