Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome (METCO-2013)

• ClinicalTrials.gov Identifier: NCT01890330
• Recruitment Status: Completed
• First Posted: July 1, 2013
• Last Update Posted: May 12, 2016
• Sponsor: University of Manitoba
• Collaborators: Alberta Innovates Bio Solutions; Alberta Canola Producers Commission; Canola Council of Canada
• Information provided by (Responsible Party): Dr. Carla Taylor, University of Manitoba

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Other: Canola Oil 25 g/d; Other: Non-Canola Oil Mixture 25 g/d	Not Applicable

Detailed Description:

The current, worldwide obesity epidemic is significantly increasing the number of individuals with Metabolic Syndrome (MetS), an early stage combination of risk factors which predisposes individuals to cardiovascular disease (CVD) and other chronic diseases. While it has been shown that modification of dietary fat intake can play an important role in prevention and management of CVD there is an absence of dietary intervention studies focusing on dietary oils and early stage modification of MetS components, particularly those affecting progression to CVD.

The composition of canola oil is considered healthy. However, there is a lack of scientifically sound clinical studies directly comparing canola oil with other fats in the diet. Given that much of the evidence for current dietary recommendations for type and amounts of fatty acids is based on heart disease, the proposed research will contribute to the knowledge base for dietary fat recommendations for individuals with MetS.

Specifically, 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome
• Study Start Date: July 2013
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Canola Oil 25 g/d; 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; Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.
Active Comparator: Non-Canola Oil Mixture 25 g/d; 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; Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.

Outcome Measures

Primary Outcome Measures :

1. Change in Fasting Serum LDL-cholesterol [ Time Frame: Baseline, Week 6 and Week 12 ]
   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.

Secondary Outcome Measures :

1. Change in Blood Vessel Function [ Time Frame: Baseline, Week 6 and Week 12 ]
   Blood vessel function will assessed and compared at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) via pulse wave analysis and pulse ave velocity.
2. Change in Total Cholesterol [ Time Frame: Baseline, Week 6, and Week 12 ]
   A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of serum total cholesterol
3. Change in Advanced Glycation Endproducts (AGEs) [ Time Frame: Baseline, Week 6, and Week 12 ]
   Advanced Glycation Endproducts (AGEs) will be obtained and compared at Baseline (Day 1), Week 6 (Day 56), and Week 12 (Day 84) using the AGE Reader.
4. Change in Biomarkers of Vascular Function [ Time Frame: Baseline, Week 6 and Week 12 ]
   A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56), and Week 12 (Day 84) for the assessment and comparison of biomarkers of vascular function, inflammation, oxidative stress, and immune function.
5. Change in Total Body Fat Composition [ Time Frame: Baseline and Week 12 ]
   Participants will undergo a body composition scan using a GE Lunar Dual Energy X-Ray Absorptiometry scanner to determine the percentage of total body fat, abdominal fat, and percentage of lean muscle mass at Baseline (Day 1) and Week 12 (Day 84).
6. Change in Fatty Liver [ Time Frame: Baseline and Week 12 ]
   Fatty liver will be assessed through serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
7. Change in Anthropometrics [ Time Frame: Baseline, Week 6 and Week 12 ]
   Weight, body mass index (BMI), and waist circumference and will be obtained and compared at with Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84).
8. Change in HDL-Cholesterol [ Time Frame: Baseline, Week 6, and Week 12 ]
   A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of HDL-cholesterol.
9. Change in Triglycerides [ Time Frame: Baseline, Week 6, and Week 12 ]
   A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of serum triglycerides.
10. Change in Fasting Blood Glucose [ Time Frame: Baseline, Week 6 and Week 12 ]
    A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of glucose.
11. Change in Fasting Insulin [ Time Frame: Baseline, Week 6 and Week 12 ]
    A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of insulin (and calculation of insulin sensitivity using HOMA-IR, QUICKI).
12. Change in Glycated Hemoglobin (HbA1c) [ Time Frame: Baseline, Week 6 and Week 12 ]
    A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of glycated hemoglobin (HbA1c).
13. Change in fasting C-reactive protein [ Time Frame: Baseline, Week 6 and Week 12 ]
    A fasting blood sample will be obtained at Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) for analysis and comparison of C-reactive protein.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male, or non-pregnant, non-lactating females, aged 20 - 75 years;
2. LDL-Cholesterol >2.5 mmol/L and <5.0 mmol/L

3. 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.
4. Able to read, write and communicate orally in English;
5. Willing to maintain a stable level of activity during participation in the study;
6. 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;
7. Willing to comply with protocol requirements and procedures;
8. Willing to provide written informed consent.

Exclusion Criteria:

1. Use of prescribed medications for lowering or managing blood lipids (hyperlipidemia), blood glucose (hyper/hypoglycemia), blood pressure (hypertension) or body weight;
2. 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;
3. Participating in or adhering to a weight loss diet or physical activity program designed to facilitate weight loss.
4. Adhering to a physician or dietitian directed lifestyle or dietary modification program for the purpose of lowering hypercholesterolemia;
5. Medical history of liver disease, with the exception of fatty liver, or chronic renal disease;

5. 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.

Contacts and Locations

Locations

Canada, Manitoba

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

Winnipeg, Manitoba, Canada, R2H 2A6

Sponsors and Collaborators

University of Manitoba

Alberta Innovates Bio Solutions

Alberta Canola Producers Commission

Canola Council of Canada

Investigators

• Principal Investigator: Carla Taylor, PhD; University of Manitoba

More Information

Additional Information:

Canadian Centre for Agri-Food Research in Health and Medicine 

Publications of Results:

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.

Other Publications:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dr. Carla Taylor, Professor and Principal Investigator, University of Manitoba
• ClinicalTrials.gov Identifier: NCT01890330
• Other Study ID Numbers: B2013:006
• First Posted: July 1, 2013
• Last Update Posted: May 12, 2016
• Last Verified: May 2016

Keywords provided by Dr. Carla Taylor, University of Manitoba:

Canola Oil; Metabolic Syndrome; Serum LDL cholesterol

Additional relevant MeSH terms:

Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases