Back to results

Canola Oil Multi-center Intervention Trial II (COMITII)

Primary Purpose

Cardiovascular Disease, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Canola Oil

High oleic acid canola oil

Western diet oil combination

About this trial

This is an interventional prevention trial for Cardiovascular Disease

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Penn State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Canola oil

High oleic acid canola oil

Western diet oil combination

Arm Description

regular canola oil

high stability/high oleic canola oil

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

Outcomes

Primary Outcome Measures

Body composition

Will be measured using DXA

Plasma lipids

Flow mediated dilation (FMD) for endothelial function

Lipoprotein subclasses

Inflammatory markers

Lipid Peroxidation

Secondary Outcome Measures

Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers

Genetic analysis to evaluate the association between FADS 1 and FADS 2 mRNA and protein expression in peripheral blood mononuclear blood cells (PBMCs)

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

Full Information

NCT ID

NCT03054779

First Posted

April 28, 2015

Last Updated

August 16, 2023

Sponsor

Penn State University

Collaborators

Canola Council of Canada, University of Manitoba, Laval University, Unity Health Toronto, St. Boniface Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03054779

Brief Title

Canola Oil Multi-center Intervention Trial II

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 2014 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Penn State University

Collaborators

Canola Council of Canada, University of Manitoba, Laval University, Unity Health Toronto, St. Boniface Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Disease, Metabolic Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canola oil

Arm Type

Experimental

Arm Description

regular canola oil

Arm Title

High oleic acid canola oil

Arm Type

Experimental

Arm Description

high stability/high oleic canola oil

Arm Title

Western diet oil combination

Arm Type

Active Comparator

Arm 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

Intervention Type

Other

Intervention Name(s)

Canola Oil

Intervention Description

Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.

Intervention Type

Other

Intervention Name(s)

High oleic acid canola oil

Intervention Description

High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.

Intervention Type

Other

Intervention Name(s)

Western diet oil combination

Intervention Description

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

Primary Outcome Measure Information:

Title

Body composition

Description

Will be measured using DXA

Time Frame

1 year 6 months

Title

Plasma lipids

Time Frame

1 year 6 months

Title

Flow mediated dilation (FMD) for endothelial function

Time Frame

1 year 6 months

Title

Lipoprotein subclasses

Time Frame

1 year 6 months

Title

Inflammatory markers

Time Frame

1 year 6 months

Title

Lipid Peroxidation

Time Frame

1 year 6 months

Secondary Outcome Measure Information:

Title

Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers

Time Frame

1 year 6 months

Title

Genetic analysis to evaluate the association between FADS 1 and FADS 2 mRNA and protein expression in peripheral blood mononuclear blood cells (PBMCs)

Time Frame

1 year 6 months

Title

Physical activity level

Description

Will be assessed using an Actigraph GT3X+ activity monitor to be worn for 1 week at the end of each treatment period

Time Frame

1 year 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Penny M Kris-Etherton, PhD

Organizational Affiliation

Penn State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State University

City

University Park

State/Province

Pennsylvania

ZIP/Postal Code

16802

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Canola Oil Multi-center Intervention Trial II

We'll reach out to this number within 24 hrs