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

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • 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

  • Name: Thanh Ho, BSc
  • Phone Number: 2087 416-864-6060
  • Email: hoho@smh.ca

Study Locations

    • 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

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
Intervention / Treatment
Experimental: Coconut oil
Shake with 50 g Coconut oil
Shake with 50 g Canola oil
Shake with 50 g Grapeseed oil
Shake with 50 g Chia oil
Shake with 50 g Butter
Experimental: Canola oil
Shake with 50 g Coconut oil
Shake with 50 g Canola oil
Shake with 50 g Grapeseed oil
Shake with 50 g Chia oil
Shake with 50 g Butter
Experimental: Grapeseed oil
Shake with 50 g Coconut oil
Shake with 50 g Canola oil
Shake with 50 g Grapeseed oil
Shake with 50 g Chia oil
Shake with 50 g Butter
Experimental: Chia oil
Shake with 50 g Coconut oil
Shake with 50 g Canola oil
Shake with 50 g Grapeseed oil
Shake with 50 g Chia oil
Shake with 50 g Butter
Placebo Comparator: Butter
Shake with 50 g Coconut oil
Shake with 50 g Canola oil
Shake with 50 g Grapeseed oil
Shake with 50 g Chia oil
Shake with 50 g Butter

What is the study measuring?

Primary Outcome Measures

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

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.

Investigators

  • 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

June 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 9, 2013

First Submitted That Met QC Criteria

June 9, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

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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