Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome

NCT01890330 | Completed

• 1 other identifier: B2013:006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS is a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low HDL-cholesterol, hypertension, elevated fasting blood glucose) accompanied by low grade chronic inflammation, hepatic steatosis (fatty liver) and reduced vascular function. This study will investigate the effect of a 12 week intervention with canola oil versus the typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS parameters. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.

Conditions

Metabolic Syndrome

Keywords

Canola Oil; Metabolic Syndrome; Serum LDL cholesterol

Outcome Measures

Primary Outcomes (1)

• Change in Fasting Serum LDL-cholesterol

  Fasting blood sample will be taken at Baseline (Day 1), Week 6 (Day 56) amd Week 12 (Day 84) for purpose of analysis of Serum LDL-Cholesterol.

  Baseline, Week 6 and Week 12

Secondary Outcomes (13)

• Change in Blood Vessel Function

  Baseline, Week 6 and Week 12

• Change in Total Cholesterol

  Baseline, Week 6, and Week 12

• Change in Advanced Glycation Endproducts (AGEs)

  Baseline, Week 6, and Week 12

• Change in Biomarkers of Vascular Function

  Baseline, Week 6 and Week 12

• Change in Total Body Fat Composition

  Baseline and Week 12

Study Arms (2)

Canola Oil 25 g/d

EXPERIMENTAL

Participants randomized to this arm will be provided with food items including entrées, side dishes, salad dressing, baked goods, and desserts prepared with traditional canola oil to incorporate into their usual eating pattern. They will consume one or two food items per day containing a total of 25 g/d of Canola oil.

Other: Canola Oil 25 g/d

Non-Canola Oil Mixture 25 g/d

ACTIVE COMPARATOR

Participants randomized to this arm will be provided with food items including entrées, side dishes, salad dressing, baked goods, and desserts prepared with an oil mixture representing the typical Western diet to incorporate into their usual eating pattern. They will consume one or two food items per day containing a total of 25 g/d of the non-canola oil mixture.

Other: Non-Canola Oil Mixture 25 g/d

Interventions

Canola Oil 25 g/d OTHER

Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.

Canola Oil 25 g/d

Non-Canola Oil Mixture 25 g/d OTHER

Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.

Non-Canola Oil Mixture 25 g/d

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, or non-pregnant, non-lactating females, aged 20 - 75 years;
• LDL-Cholesterol \>2.5 mmol/L and \<5.0 mmol/L
• If the participant has 2 or more of the following characteristics of MetS
• Fasting blood glucose \>5.6 mmol/L and \<7.0 mmol/L;
• Blood pressure \>130/85 mm Hg and \<150/100;
• Triglycerides \>1.7 mmol/L and \<4.0 mmol/L;
• HDL-cholesterol \<1.0 mmol/L in males or \<1.3 mmol/L in females;
• Abdominal obesity as defined by a waist circumference of \>102 cm (40 inches) in males and \>88 cm (35 inches) in females of non-Asian ethnicity, and a waist circumference of \>94 cm (37 inches) in males and \>80 cm (32 inches) in females of Asian ethnicity.
• Able to read, write and communicate orally in English;
• Willing to maintain a stable level of activity during participation in the study;
• Willing to maintain dietary routine, refrain from consuming omega-3 supplements or omega-3 rich foods (\>0.3 grams ALA/serving or, \>0.1 grams of EPA and DHA; see handout with examples) and refrain from taking any over-the-counter medications or herbal supplements specified for weight loss, or the lowering of blood lipids, blood glucose or blood pressure from acceptance into the study until the final study visit;
• Willing to comply with protocol requirements and procedures;
• Willing to provide written informed consent.

You may not qualify if:

• Use of prescribed medications for lowering or managing blood lipids (hyperlipidemia), blood glucose (hyper/hypoglycemia), blood pressure (hypertension) or body weight;
• Regular use of non-prescription products, over-the-counter medications, or herbal supplements designed to lower blood lipids, blood glucose, blood pressure or body weight, or omega-3 supplements or omega-3 rich foods, within the past 3 months;
• Participating in or adhering to a weight loss diet or physical activity program designed to facilitate weight loss.
• Adhering to a physician or dietitian directed lifestyle or dietary modification program for the purpose of lowering hypercholesterolemia;
• Medical history of liver disease, with the exception of fatty liver, or chronic renal disease;
• \. Any acute medical condition or surgical intervention within the past 3 months; 6. Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results; 7. History of gastrointestinal reactions or allergies to canola oil or to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed; and 8. Currently participating in or having participated in a food intervention study within the last 3 months.

Sponsors & Collaborators

• University of Manitoba: lead
• Alberta Innovates Bio Solutions: collaborator
• Alberta Canola Producers Commission: collaborator
• Canola Council of Canada: collaborator

Study Sites (1)

St. Boniface General Hospital - I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (3)

• Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.

  PMID: 17167477 BACKGROUND

• Jakobsen MU, O'Reilly EJ, Heitmann BL, Pereira MA, Balter K, Fraser GE, Goldbourt U, Hallmans G, Knekt P, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Ascherio A. Major types of dietary fat and risk of coronary heart disease: a pooled analysis of 11 cohort studies. Am J Clin Nutr. 2009 May;89(5):1425-32. doi: 10.3945/ajcn.2008.27124. Epub 2009 Feb 11.

  PMID: 19211817 RESULT

• Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.

  PMID: 33380172 DERIVED

Related Links

• Canadian Centre for Agri-Food Research in Health and Medicine

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Rapeseed Oil

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Carla Taylor, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Principal Investigator

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: July 1, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

CA (1)