We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Canola Oil Multicentre Intervention Trial (COMIT) (COMIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01233778
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : March 15, 2013
Sponsor:
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objectives of this study are to examine how the consumption of treatment oils (including canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil) influence endothelial function, inflammation, oxidation, body composition, and plasma lipoprotein characterization.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: Canola Oil Dietary Supplement: High Oleic Acid + DHA Canola Oil Dietary Supplement: High Oleic Acid Canola Oil Dietary Supplement: Flax Oil Dietary Supplement: Safflower Oil Not Applicable

Detailed Description:

The consequence of total fat consumption on circulating plasma lipids and the incidence of cardiovascular disease has long been a central theme in nutrition research. Less well known is the influence of specific fatty acids on vascular endothelial function and the oxidative and inflammatory responses characteristic of atherogenesis. Omega 3 ( ω-3) fatty acids, including plant derived alpha-linolenic acid (18:3n-3, ALA) and marine derived eicosapentaenoic (20:5n-3, EPA) and docosahexaenoic acid (22:6n-3, DHA) have been shown to effectively modulate multiple cardiovascular risk factors in epidemiological, animal model and human clinical investigations. ALA is most commonly consumed as a major component of dietary canola and flaxseed oils and has a recommended intake of 1.1 and 1.6 g/d for women and men, respectively. EPA and DHA are consumed as fatty fish or fish oil and algae supplements with current recommended intakes of 500 mg/d (combined EPA and DHA).

ALA is thought to improve cardiovascular health by modulating circulating lipid concentrations, altering membrane structure and function by enhancing the total ω-3 fatty acid content of cell membrane phospholipids, and reducing inflammatory reactions by blocking the formation of arachidonic acid derived eicosanoids. However, there are extensive knowledge gaps in our understanding of the molecular mechanisms and clinical efficacy of ω-3 fatty acids in human health and disease prevention. Therefore, the purpose of this study is to further examine these relationships.

Feeding protocol and study treatments:

The study will proceed as a double blind, randomized cross-over controlled feeding study. Each treatment phase will be 30 days in duration, separated by 4-week washout periods. Subjects will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate, and 15% protein) supplemented with 60g/d of the following treatment oils: 1) canola oil; 2) DHA enriched canola-oil; 3) high oleic acid canola oil; 4) flax/corn oil (40:60); or 5) safflower/corn oil (75:25). Study diets will be prepared in a metabolic kitchen facility at each clinical site. Three isocaloric meals will be prepared each day for every subject. A 7-day rotating menu cycle will be used. Subjects will consume at least 1 of 3 daily meals under supervision. The other meals will be prepared and packed for every subject to be taken out. The study control and intervention oils will be delivered in milkshakes provided twice daily. Subjects will be instructed to consume only the prepared meals and limit their intake of alcohol to 2 drinks/week and caffeinated calorie free beverages to 40oz (5 drinks) per day. Diets will be planned for every subject according to his/her energy requirements and will be nutritionally adequate.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Canola Oil Dietary Supplement: Canola Oil
60g Canola oil daily per 3000kcal diet provided in a supplemental shake
Experimental: High Oleic Acid Canola + DHA Dietary Supplement: High Oleic Acid + DHA Canola Oil
60g high oleic acid canola oil + DHA daily per 3000kcal provided in a supplemental shake
Experimental: High Oleic Canola Oil Dietary Supplement: High Oleic Acid Canola Oil
60g high oleic acid canola oil daily per 3000kcal provided in a supplemental shake
Experimental: Flax & Safflower Oil (60:40) Dietary Supplement: Flax Oil
36g flax oil + 24g safflower oil daily per 3000kcal provided in a supplemental shake
Experimental: Safflower & Corn Oil (75:25) Dietary Supplement: Safflower Oil
45g safflower oil + 15g corn oil daily per 3000kcal provided in a supplemental shake


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Endothelial Health [ Time Frame: End of diet period 1 (week 4) ]
    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

  2. Endothelial Health [ Time Frame: End of diet period 2 (week 12) ]
    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

  3. Endothelial Health [ Time Frame: End of diet period 3 (week 20) ]
    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

  4. Endothelial Health [ Time Frame: End of diet period 4 (week 28) ]
    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

  5. Endothelial Health [ Time Frame: End of diet period 5 (week 36) ]
    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.


Secondary Outcome Measures :
  1. Body Composition [ Time Frame: Week 4, 12, 20, 28 and 36 - End of each diet period ]
    To assess regional changes in body fat deposition, subjects will undergo a dual energy X-ray absorptiometry (DXA) scan at baseline (beginning of study) and end of each intervention period. Waist circumference measurements also will be taken at this time to track how much fat is lost from the abdominal area of the body.

  2. Production of long chain fatty acids [ Time Frame: Week 4, 12, 20, 28 and 36 - End of each diet period ]
    On the 29th day of each diet phase you will be asked to consume three tablespoons of tagged water (known as deuterium). The movement of these tagged materials will allow us to assess the quantity of long chain fatty acids (EPA and DHA) that your body is producing in response to your diet. All of the above tagged materials are non-radioactive, non-toxic, and do not pose any health risk to you. Another fasting blood sample will be obtained when you return the next morning.

  3. Plasma Lipids [ Time Frame: Week 4, 12, 20, 28 and 36 - End of each diet period ]
    Twelve-hour fasting blood samples (30ml) will be collected on day 1, 2, 29 and 30 for analyses of plasma lipids. Blood samples obtained on day 1 and 2 will be used to measure baseline values for study endpoints, whereas blood samples obtained on the two last days will be used to measure final endpoint values.

  4. Plasma Cytokines [ Time Frame: Week 4, 12, 20, 28 and 36 - End of each diet period ]
    Twelve-hour fasting blood samples (30ml) will be collected on day 1, 2, 29 and 30 for analyses of C-reactive protein and inflammatory cytokines. Blood samples obtained on day 1 and 2 will be used to measure baseline values for study endpoints, whereas blood samples obtained on the two last days will be used to measure final endpoint values.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 20-65 years
  • BMI = 22-32 kg/m2

In addition, eligibility will be based on metabolic syndrome criteria where we define eligibility on the basis of subjects having elevated waist circumference + 1 or more of the remaining 5 criteria:

  • Elevated waist circumference - > 102 cm for men and >88 cm for women
  • Elevated triglycerides - ≥ 1.7 mmol/L ( ≥150mg/dl) ( no upper limit)
  • Reduced HDL - < 1 mmol/L (<40 mg/dl) for men and < 1.3 mmol/L (<50 mg/dl)for women
  • Fasting glucose - ≥ 100 mg/dl (no upper limit)

  • Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG

    • Unmedicated participants - upper limit of Stage 1 Hypertension: systolic ≤ 159 and/or diastolic ≤ 99 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:

  • Smokers**
  • History of thyroid disease, diabetes, kidney or liver disease, heart disease, or other chronic diseases
  • Heavy alcohol consumption (>14 drinks/week)
  • Chronic anti-inflammatory medication use
  • Lactation, pregnancy, or desire to become pregnant during the study
  • Taking lipid lowering medications (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil probucol, HMG CoA reductase inhibitors) within the last three months
  • Not willing to refrain from blood/plasma donation during the study period

  • Gall bladder removal

    • For purposes of the this study non-smoking is defined as >6 months smoke-free; there is some evidence to show that smoking cessation increases HDL levels and 6 months is adequate time for this to stabilize, however this time span was chosen based on the decreased rate of relapse after 6 months.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233778


Locations
Layout table for location information
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
University of Manitoba
Investigators
Layout table for investigator information
Principal Investigator: Penny M Kris-Etherton, PhD, RD Penn State University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Penny Kris-Etherton, RD, PhD, Penn State University
ClinicalTrials.gov Identifier: NCT01233778    
Other Study ID Numbers: PKE COMIT
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by Penny Kris-Etherton, Penn State University:
Cardiovascular disease
Omega-3 fatty acids
Inflammation
Endothelial function
Canola oil
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases