- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01876394
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
Unknown
Conditions
Intervention / Treatment
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.
Sponsor
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
Other Study ID 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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