Canola Oil Multi-center Intervention Trial II (COMITII)

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Metabolic Syndrome; Cardiovascular Disease

Treatments: Other: Western diet oil combination; Other: Canola Oil; Other: High oleic acid canola oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03054779

PKE COMIT II

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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]

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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28 participants in 3 patient groups

Canola oil

Experimental group

Description:

regular canola oil

Treatment:

Other: Canola Oil

High oleic acid canola oil

Experimental group

Description:

high stability/high oleic canola oil

Treatment:

Other: High oleic acid canola oil

Western diet oil combination

Active Comparator group

Description:

a typical "Western diet" fat intake comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA

Treatment:

Other: Western diet oil combination