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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Manitoba
Sponsor:
Collaborators:
Alberta Innovates - Bio Solutions
Alberta Canola Producers Commission
Canola Council of Canada
Information provided by (Responsible Party):
Dr. Carla Taylor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01890330
First received: June 3, 2013
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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 Intervention
Metabolic Syndrome
Other: Canola Oil 25 g/d
Other: Non-Canola Oil Mixture 25 g/d

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change in Fasting Serum LDL-cholesterol [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    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:
  • Change in Blood Vessel Function [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change in Total Cholesterol [ Time Frame: Baseline, Week 6, and Week 12 ] [ Designated as safety issue: No ]
    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

  • Change in Advanced Glycation Endproducts (AGEs) [ Time Frame: Baseline, Week 6, and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change in Biomarkers of Vascular Function [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change in Total Body Fat Composition [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change in Fatty Liver [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Fatty liver will be assessed through serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

  • Change in Anthropometrics [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change in HDL-Cholesterol [ Time Frame: Baseline, Week 6, and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change in Triglycerides [ Time Frame: Baseline, Week 6, and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change in Fasting Blood Glucose [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change in Fasting Insulin [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change in Glycated Hemoglobin (HbA1c) [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change in fasting C-reactive protein [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Bone Mass Density [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participants will have the option of undergoing scans for bone density of the hip, lumbar region and forearm. These additional bone density scans will be acquired using Dual Emission X-Ray Absorptiometry (DEXA) and will be used to analyze how metabolic syndrome and body composition are related to bone density.


Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890330

Contacts
Contact: Carla Taylor, PhD 204-258-1361 Carla.Taylor@ad.umanitoba.ca
Contact: Peter C Zahradka, PhD 204-235-3507 pzahradka@sbrc.ca

Locations
Canada, Manitoba
St. Boniface General Hospital - I.H. Asper Clinical Research Institute Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Carla Taylor, PhD    204-258-1361    Carla.Taylor@ad.umanitoba.ca   
Contact: Peter C Zahradka, PhD    204-235-3507    pzahradka@sbrc.ca   
Principal Investigator: Carla Taylor, PhD         
Sub-Investigator: Peter Zahradka, PhD         
Sub-Investigator: Asad Junaid, MD         
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:
Publications:
Responsible Party: Dr. Carla Taylor, Professor and Principal Investigator, University of Manitoba
ClinicalTrials.gov Identifier: NCT01890330     History of Changes
Other Study ID Numbers: B2013:006
Study First Received: June 3, 2013
Last Updated: August 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Canola Oil
Metabolic Syndrome
Serum LDL cholesterol

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014