HealthyCOILNCT01876394
Comparison of Dietary Fats on Vascular Parameters
A study testing Coconut Oil, Canola Oil and Grapeseed Oil in people with Healthy, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Coconut Oil, Canola Oil and Grapeseed Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Age 18-65 years
- BMI < 30 kg/m2
- Brachial systolic blood pressure ≤ 140 mmHg
- Brachial diastolic blood pressure ≤ 90 mmHg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Coconut Oil, Canola Oil, Grapeseed Oil, Chia Oil, Butter
- Keywords
- Healthy, Arterial Stiffness, Blood Pressure, Blood Glucose, Vascular Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut OilOther
Shake with 50 g Coconut oil
Canola OilOther
Shake with 50 g Canola oil
Grapeseed OilOther
Shake with 50 g Grapeseed oil
Chia OilOther
Shake with 50 g Chia oil
ButterOther
Shake with 50 g Butter
| Study group | Role | What they receive |
|---|---|---|
| Coconut oil | Experimental | Not described Receives: Other: Coconut Oil; Other: Canola Oil; Other: Grapeseed Oil; Other: Chia Oil; Other: Butter |
| Canola oil | Experimental | Not described Receives: Other: Coconut Oil; Other: Canola Oil; Other: Grapeseed Oil; Other: Chia Oil; Other: Butter |
| Grapeseed oil | Experimental | Not described Receives: Other: Coconut Oil; Other: Canola Oil; Other: Grapeseed Oil; Other: Chia Oil; Other: Butter |
| Chia oil | Experimental | Not described Receives: Other: Coconut Oil; Other: Canola Oil; Other: Grapeseed Oil; Other: Chia Oil; Other: Butter |
| Butter | Placebo comparator | Not described Receives: Other: Coconut Oil; Other: Canola Oil; Other: Grapeseed Oil; Other: Chia Oil; Other: Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare 5 different dietary fat sources in a liquid meal on postprandial changes in augmentation index (AIx)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2014
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vuksan Vladimir, PhD, Principal investigator, Risk Factor Modification Centre - St. Michael's HospitalAlexandra Jenkins (Co-investigator), PhD, RD, Principal investigator, Unity Health TorontoWilliam Watson (Qualified investigator), MD, Principal investigator, Unity Health TorontoElena Jovanovski (Co-investigator), MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876394
- Sponsor's protocol ID
- COIL
- Acronym
- COIL
- Status last verified
- Mar 2016
- First submitted
- 9 Jun 2013
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Dietary Fats on Postprandial Vascular Function in Healthy Individuals: Pilot Double Blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01876394
- Acronym / sponsor ID
- COIL / COIL
- Conditions
- Healthy
- Keywords
- Healthy, Arterial Stiffness, Blood Pressure, Blood Glucose, Vascular Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Coconut oil | Experimental | Other: Coconut Oil, Other: Canola Oil, Other: Grapeseed Oil, Other: Chia Oil, Other: Butter |
| Canola oil | Experimental | Other: Coconut Oil, Other: Canola Oil, Other: Grapeseed Oil, Other: Chia Oil, Other: Butter |
| Grapeseed oil | Experimental | Other: Coconut Oil, Other: Canola Oil, Other: Grapeseed Oil, Other: Chia Oil, Other: Butter |
| Chia oil | Experimental | Other: Coconut Oil, Other: Canola Oil, Other: Grapeseed Oil, Other: Chia Oil, Other: Butter |
| Butter | Placebo comparator | Other: Coconut Oil, Other: Canola Oil, Other: Grapeseed Oil, Other: Chia Oil, Other: Butter |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- Age 18-65 years
- BMI < 30 kg/m2
- Brachial systolic blood pressure ≤ 140 mmHg
- Brachial diastolic blood pressure ≤ 90 mmHg
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coconut OilShake with 50 g Coconut oil | Other | Butter, Canola oil, Chia oil, Coconut oil, Grapeseed oil |
| Canola OilShake with 50 g Canola oil | Other | Butter, Canola oil, Chia oil, Coconut oil, Grapeseed oil |
| Grapeseed OilShake with 50 g Grapeseed oil | Other | Butter, Canola oil, Chia oil, Coconut oil, Grapeseed oil |
| Chia OilShake with 50 g Chia oil | Other | Butter, Canola oil, Chia oil, Coconut oil, Grapeseed oil |
| ButterShake with 50 g Butter | Other | Butter, Canola oil, Chia oil, Coconut oil, Grapeseed oil |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vuksan Vladimir, PhD principal investigator
Risk Factor Modification Centre - St. Michael's Hospital
Alexandra Jenkins (Co-investigator), PhD, RD principal investigator
Unity Health Toronto
William Watson (Qualified investigator), MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut Oil, Canola Oil and Grapeseed Oil in people with Healthy, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanh Ho, BSc (416-864-6060 ext. 2087, hoho@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.