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

U

University of Manitoba

Status and phase

Completed
Phase 2

Conditions

Cardiovascular Disease

Treatments

Dietary Supplement: High-Oleic Canola Oil
Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend
Dietary Supplement: Western Dietary Control

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00927199
B2007:071

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

36 participants in 3 patient groups

High-Oleic Canola Oil
Experimental group
Treatment:
Dietary Supplement: High-Oleic Canola Oil
High-Oleic Canola/Flaxseed Oil Blend
Experimental group
Treatment:
Dietary Supplement: High-Oleic Canola/Flaxseed Oil Blend
Western Diet
Active Comparator group
Treatment:
Dietary Supplement: Western Dietary Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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