Healthy AdultsMCT-CocoNCT02679222
Comparing the Ketogenic Effect of Coconut Oil and Different MCTs
A study testing Coconut oil, Coconut oil + MCT and MCT in people with Healthy Adults, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each oil are evaluated individually or in combination over a 8h-period during which repeated blood sampling is performed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Coconut oil, Coconut oil + MCT and MCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult over 18 y old.
Who cannot join
- Fasting plasma glucose ≥7.0 mM (diabetics or pre-diabetics);
- Smoking
- Clinically-significant gastro-intestinal disease/conditions.
- Clinically-significant liver disease/dysfunction.
- Clinically-significant cardiac disease/conditions.
- Clinically-significant abnormal coagulation.
Show all 10Show fewer
- Taking a medication that could affect lipid and glucose metabolism
- Hypertension
- Pregnancy or breastfeeding
- Exercising more than 3 times a week
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, J1H4C4
About this study
Official title: Comparing the Ketogenic Effect of Coconut Oil and Different Medium-chain Triglycerides
The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each oil are evaluated individually or in combination over a 8h-period during which repeated blood sampling is performed.
Read the detailed description
The study is composed of eight successive visits. Each visit consists of the consumption of one individual oil or a mixture of oils (20 g of coconut oil or 10 g of coconut oil + 10 g of MCT 60-40 or 20 g MCT 60-40 or 10 g coconut oil + 10 g tricaprylin or 20 g tricaprylin or 10 g coconut oil + 10 g triheptanoate or 20 g triheptanoate) and a 8h follow-up during which repeated blood samples are taken for laboratory analysis (plasma beta-hydroxybutyrate, acetoacetate, glucose, free fatty acids, triglycerides, total cholesterol, lactate and insulin).
- Conditions
- Healthy Adults
- Being tested
- Coconut oil, Coconut oil + MCT, MCT, Coconut oil + tricaprylin, Tricaprylin
- Keywords
- Ketones, Coconut oil, Medium Chain Triglycerides
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oilDietary supplement
Also called Coco
20 g of coconut oil
Coconut oil + MCTDietary supplement
Also called Coco+MCT
10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)
MCTDietary supplement
20 g of MCT (60 of C8+40 of C10)
Coconut oil + tricaprylinDietary supplement
Also called Coco+C8
10 g coconut oil + 10 g tricaprylin
TricaprylinDietary supplement
Also called C8
20 g tricaprylin
TricaprinDietary supplement
Also called C10
20 g tricaprin
ControlDietary supplement
Also called CTL
No supplement taken on this visit
| Study group | Role | What they receive |
|---|---|---|
| Supplementation | Experimental | Protocol involved seven separate but identical metabolic study days for each participant. the test substances were evaluated in random order: vehicle (Control) or 20 mL of the test oils (Coconut oil; tricaprin; tricaprylin; MCT [tricaprylin/tricaprin]; coconut oil + MCT [50:50]; Coconut oil + tricaprylin [50:50]) taken twice, once at breakfast and once at mid-day. Receives: Dietary Supplement: Coconut oil; Dietary Supplement: Coconut oil + MCT; Dietary Supplement: MCT; Dietary Supplement: Coconut oil + tricaprylin; Dietary Supplement: Tricaprylin; Dietary Supplement: Tricaprin; Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Ketone Concentrations
Total ketones = Plasma acetoacetate (µmol/L) + beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e. daily mean).
Samples are taken every 30 minutes on a 8 hours period. The mean is reported here.
Measured: 8 hours
Secondary outcomes (1)
Plasma Acetoacetate/Beta-hydroxybutyrate Ratio
Plasma ratio of acetoacetate (µmol/L)/ beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e area-under-the-curve over 8 hours).
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Cunnane, PhD, Principal investigator, CSSS-IUGS - CIUSSS de L'Estrie - CHUS - Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679222
- Sponsor's protocol ID
- 2016-541
- Acronym
- MCT-Coco
- Status last verified
- Mar 2020
- First submitted
- 1 Feb 2016
- Last updated
- 6 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Ketogenic Effect of Coconut Oil and Different Medium-chain Triglycerides
- ClinicalTrials.gov ID
- NCT02679222
- Acronym / sponsor ID
- MCT-Coco / 2016-541
- Conditions
- Healthy Adults
- Keywords
- Ketones, Coconut oil, Medium Chain Triglycerides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Posted 6 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each oil are evaluated individually or in combination over a 8h-period during which repeated blood sampling is performed.
Detailed description
The study is composed of eight successive visits. Each visit consists of the consumption of one individual oil or a mixture of oils (20 g of coconut oil or 10 g of coconut oil + 10 g of MCT 60-40 or 20 g MCT 60-40 or 10 g coconut oil + 10 g tricaprylin or 20 g tricaprylin or 10 g coconut oil + 10 g triheptanoate or 20 g triheptanoate) and a 8h follow-up during which repeated blood samples are taken for laboratory analysis (plasma beta-hydroxybutyrate, acetoacetate, glucose, free fatty acids, triglycerides, total cholesterol, lactate and insulin).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplementation | Experimental | Dietary Supplement: Coconut oil, Dietary Supplement: Coconut oil + MCT, Dietary Supplement: MCT, Dietary Supplement: Coconut oil + tricaprylin, Dietary Supplement: Tricaprylin, Dietary Supplement: Tricaprin, Dietary Supplement: ControlProtocol involved seven separate but identical metabolic study days for each participant. the test substances were evaluated in random order: vehicle (Control) or 20 mL of the test oils (Coconut oil; tricaprin; tricaprylin; MCT [tricaprylin/tricaprin]; coconut oil + MCT [50:50]; Coconut oil + tricaprylin [50:50]) taken twice, once at breakfast and once at mid-day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult over 18 y old.
Key exclusion criteria (10 listed)
- Fasting plasma glucose ≥7.0 mM (diabetics or pre-diabetics);
- Smoking
- Clinically-significant gastro-intestinal disease/conditions.
- Clinically-significant liver disease/dysfunction.
- Clinically-significant cardiac disease/conditions.
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 oilAlso: Coco20 g of coconut oil | Dietary supplement | Supplementation |
| Coconut oil + MCTAlso: Coco+MCT10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10) | Dietary supplement | Supplementation |
| MCT20 g of MCT (60 of C8+40 of C10) | Dietary supplement | Supplementation |
| Coconut oil + tricaprylinAlso: Coco+C810 g coconut oil + 10 g tricaprylin | Dietary supplement | Supplementation |
| TricaprylinAlso: C820 g tricaprylin | Dietary supplement | Supplementation |
| TricaprinAlso: C1020 g tricaprin | Dietary supplement | Supplementation |
| ControlAlso: CTLNo supplement taken on this visit | Dietary supplement | Supplementation |
Primary outcome
Plasma Ketone Concentrations
Time frame: 8 hours
Total ketones = Plasma acetoacetate (µmol/L) + beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e. daily mean). Samples are taken every 30 minutes on a 8 hours period. The mean is reported here.
1 secondary outcome
Plasma Acetoacetate/Beta-hydroxybutyrate Ratio
Time frame: 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Stephen Cunnane, PhD principal investigator
CSSS-IUGS - CIUSSS de L'Estrie - CHUS - Université de Sherbrooke
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, Coconut oil + MCT and MCT in people with Healthy Adults, run by Université de Sherbrooke 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 6 Apr 2020. 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. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Ketone Concentrations (time frame: 8 hours). 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 6 Apr 2020.