Status:
COMPLETED
Canola Oil Multicentre Intervention Trial (COMIT)
Lead Sponsor:
Penn State University
Collaborating Sponsors:
University of Manitoba
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
The objectives of this study are to examine how the consumption of treatment oils (including canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil) influence end...
Detailed Description
The consequence of total fat consumption on circulating plasma lipids and the incidence of cardiovascular disease has long been a central theme in nutrition research. Less well known is the influence ...
Eligibility Criteria
Inclusion
- Aged 20-65 years
- BMI = 22-32 kg/m2
- In addition, eligibility will be based on metabolic syndrome criteria where we define eligibility on the basis of subjects having elevated waist circumference + 1 or more of the remaining 5 criteria:
- Elevated waist circumference - \> 102 cm for men and \>88 cm for women
- Elevated triglycerides - ≥ 1.7 mmol/L ( ≥150mg/dl) ( no upper limit)
- Reduced HDL - \< 1 mmol/L (\<40 mg/dl) for men and \< 1.3 mmol/L (\<50 mg/dl)for women
- Fasting glucose - ≥ 100 mg/dl (no upper limit)
- Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG
- Unmedicated participants - upper limit of Stage 1 Hypertension: systolic ≤ 159 and/or diastolic ≤ 99 mm HG and participants must be free of end stage/target organ disease symptoms
- BP medicated participants: acceptable as long as individuals meet the specified blood pressure range of \<140/90 mmHg, and have been stable for at least 6 months.
Exclusion
- Smokers\*\*
- History of thyroid disease, diabetes, kidney or liver disease, heart disease, or other chronic diseases
- Heavy alcohol consumption (\>14 drinks/week)
- Chronic anti-inflammatory medication use
- Lactation, pregnancy, or desire to become pregnant during the study
- Taking lipid lowering medications (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil probucol, HMG CoA reductase inhibitors) within the last three months
- Not willing to refrain from blood/plasma donation during the study period
- Gall bladder removal
- For purposes of the this study non-smoking is defined as \>6 months smoke-free; there is some evidence to show that smoking cessation increases HDL levels and 6 months is adequate time for this to stabilize, however this time span was chosen based on the decreased rate of relapse after 6 months.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01233778
Start Date
October 1 2010
End Date
April 1 2012
Last Update
August 21 2023
Active Locations (1)
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1
Penn State University
University Park, Pennsylvania, United States, 16802