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Canola Oil Multi-center Intervention Trial II (COMITII)

The Pennsylvania State University (PENNSTATE) logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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