Comparison of Dietary Fats on Vascular Parameters (COIL)

March 9, 2016 updated by: Unity Health Toronto

Acute Effects of Dietary Fats on Postprandial Vascular Function in Healthy Individuals: Pilot Double Blind, Randomized, Controlled Trial

The purpose of the study is to examine the effect of consuming 50g of fat from 5 different sources (coconut, canola, grapeseed, chia, and butter) on arterial stiffness, blood pressure and blood glucose levels. It is hypothesized that butter will have the most detrimental effect on acute vascular function. Canola, grapeseed and chia oil with their decreased content of SFA are hypothesized to impair vascular function to a lesser extent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Thanh Ho, BSc
  • Phone Number: 2087 416-864-6060
  • Email: hoho@smh.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • Risk Factor Modification Centre, St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Age 18-65 years
  • BMI < 30 kg/m2
  • Brachial systolic blood pressure ≤ 140 mmHg
  • Brachial diastolic blood pressure ≤ 90 mmHg

Exclusion Criteria:

  • Women of childbearing age must not be pregnant or breastfeeding at the time of the study
  • BMI >35kg/m2
  • Hypertensive as defined by brachial SBP >140mmHg and/or DBP >90mmHg
  • Sensitivity to the study product or its sources
  • Presence of chronic conditions or illnesses
  • Having any gastrointestinal complication or condition
  • Chronic use of dietary supplements that alter fat absorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Coconut oil
Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Grapeseed Oil
Shake with 50 g Grapeseed oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter
Experimental: Canola oil
Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Grapeseed Oil
Shake with 50 g Grapeseed oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter
Experimental: Grapeseed oil
Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Grapeseed Oil
Shake with 50 g Grapeseed oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter
Experimental: Chia oil
Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Grapeseed Oil
Shake with 50 g Grapeseed oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter
Placebo Comparator: Butter
Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Grapeseed Oil
Shake with 50 g Grapeseed oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To compare 5 different dietary fat sources in a liquid meal on postprandial changes in augmentation index (AIx)
Time Frame: 5 separate mornings, measurements taken at baseline and at 60, 120 and 180 minutes
5 separate mornings, measurements taken at baseline and at 60, 120 and 180 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To investigate whether these dietary fat sources will result in blood pressure changes and a differential glycemic response
Time Frame: 5 separate mornings, blood pressure measurements will be taken at baseline, 60, 120 and 180 minutes. Blood samples will be taken at baseline 15, 30, 45, 60, 90 and 120 minutes
5 separate mornings, blood pressure measurements will be taken at baseline, 60, 120 and 180 minutes. Blood samples will be taken at baseline 15, 30, 45, 60, 90 and 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vuksan Vladimir, PhD, Risk Factor Modification Centre - St. Michael's Hospital
  • Principal Investigator: Alexandra Jenkins (Co-investigator), PhD, RD, Unity Health Toronto
  • Principal Investigator: William Watson (Qualified investigator), MD, Unity Health Toronto
  • Principal Investigator: Elena Jovanovski (Co-investigator), MSc, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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