Canola Oil Multicentre Intervention Trial (COMIT)

Completed · Not applicable

Conditions studied: Cardiovascular Disease

In brief

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 endothelial function, inflammation, oxidation, body composition, and plasma lipoprotein characterization.

Key facts

Study ID

NCT01233778

Run by

Penn State University

People needed

43

Starts

2010-10-01

Expected to finish

2012-04-01

Last updated by the study team

2023-08-21

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Penn State University — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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