Comparison of Dietary Fats on Vascular Parameters
COIL
Acute Effects of Dietary Fats on Postprandial Vascular Function in Healthy Individuals: Pilot Double Blind, Randomized, Controlled Trial
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jun 2014
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 10, 2016
March 1, 2016
1.8 years
June 9, 2013
March 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare 5 different dietary fat sources in a liquid meal on postprandial changes in augmentation index (AIx)
5 separate mornings, measurements taken at baseline and at 60, 120 and 180 minutes
Secondary Outcomes (1)
To investigate whether these dietary fat sources will result in blood pressure changes and a differential glycemic response
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
Study Arms (5)
Coconut oil
EXPERIMENTALCanola oil
EXPERIMENTALGrapeseed oil
EXPERIMENTALChia oil
EXPERIMENTALButter
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy
- Age 18-65 years
- BMI \< 30 kg/m2
- Brachial systolic blood pressure ≤ 140 mmHg
- Brachial diastolic blood pressure ≤ 90 mmHg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2013
First Posted
June 12, 2013
Study Start
June 1, 2014
Primary Completion
April 1, 2016
Study Completion
June 1, 2016
Last Updated
March 10, 2016
Record last verified: 2016-03