St. Boniface General Hospital - I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6, Canada
NCT Number: NCT01890330
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.
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Notify Me20 year–75 year
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R2H 2A6, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.
Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.
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.
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.
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
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.
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.
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).
Time frame: Baseline and Week 12
Fatty liver will be assessed through serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
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).
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.
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.
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.
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).
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).
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.
University of Manitoba
Other
Acronym: METCO-2013
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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