Canola Oil Multi-center Intervention Trial II

Completed · Not applicable

Conditions studied: Cardiovascular Disease, Metabolic Syndrome

In brief

Building on the findings from the investigators previous study, COMIT I, the purpose of the COMIT II study is to supplement the DEXA measurement of body composition with a supplementary DEXA measurement of visceral adipose tissue and to specifically target the impact of oleic acid consumption on body composition as the primary objective. COMIT II also will include analysis of fatty acid ethanolamines (FAEs) and their precursors to elucidate the mechanisms by which canola oil may be modifying body composition, measurement of endothelial function, inflammatory, adiposity and insulin sensitivity biomarkers, and genetic analyses.

Key facts

Study ID

NCT03054779

Run by

Penn State University

People needed

28

Starts

2014-09-01

Expected to finish

2016-11-01

Last updated by the study team

2023-08-21

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• waist circumference ≥94 cm for men and ≥80 cm for women
• Elevated triglycerides - ≥150 mg/dL and ≤ 400 mg/dL
• Reduced HDL - < 40 mg/dL for men and < 50 mg/dL for women
• Fasting glucose - ≥ 100 mg/dl and ≤ 126 mg/dL
• Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG [Unmedicated participants - upper limit of Stage 1 Hypertension: systolic < 160 and/or diastolic <100 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…

• Individuals with thyroid**, kidney, or liver disease [Individuals with thyroid disease whose blood values are within normal limits and that have been stable (on medication) for the past 6 months are considered eligible]
• Individuals with diabetes mellitus
• Smokers
• Individuals consuming >14 alcoholic beverages per week
• Individuals taking lipid lowering medication (ex: cholestyramine, colestipol, niacin, cloribrate, gemfibrozil, probucol, HMG CoA reductase inhibitors) for at least the last 3 months
• Pregnancy or lactation

Where it is running

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

Full record on ClinicalTrials.gov

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