Canola Oil Multi-center Intervention Trial II

Metabolic Syndrome Clinical Trial

— COMITII  

Official title:

Canola Oil Multi-center Intervention Trial II (COMIT II): Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054779
• Other study ID #: PKE COMIT II
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Canola Oil
Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
• High oleic acid canola oil
High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
• Western diet oil combination
A typical "Western diet" fat intake as a control treatment, comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA, will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
Penn State University	Canola Council of Canada, Laval University, St. Boniface Hospital, Unity Health Toronto, University of Manitoba

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Will be measured using DXA	1 year 6 months
Primary	Plasma lipids		1 year 6 months
Primary	Flow mediated dilation (FMD) for endothelial function		1 year 6 months
Primary	Lipoprotein subclasses		1 year 6 months
Primary	Inflammatory markers		1 year 6 months
Primary	Lipid Peroxidation		1 year 6 months
Secondary	Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers		1 year 6 months
Secondary	Genetic analysis to evaluate the association between FADS 1 and FADS 2 mRNA and protein expression in peripheral blood mononuclear blood cells (PBMCs)		1 year 6 months
Secondary	Physical activity level	Will be assessed using an Actigraph GT3X+ activity monitor to be worn for 1 week at the end of each treatment period	1 year 6 months