HealthyNCT02409927
Effect of MCT Emulsification on Ketogenesis in Human Adults
A study testing MCT oil 10g, MCT homogenate 10g and MCT oil 20g in people with Healthy, run by Université de Sherbrooke.
Trial summary
Lower brain glucose uptake is present before the onset of cognitive deterioration and may increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized and are ketogenic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MCT oil 10g, MCT homogenate 10g and MCT oil 20g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Sep 2014
- 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
- aged 18 years or more
Who cannot join
- smoker
- pregnancy or breastfeeding
- diabetes or insulin resistance
- uncontrolled thyroid disease, hepatic or renal disease
- uncontrolled high blood pressure
- medical treatment influencing lipid or glucide metabolism
Show all 9Show fewer
- ongoing or past severe drug or alcohol abuse
- dementia or psychiatric difficulties or depression
- chronic immune condition or inflammation
About this study
Official title: Effect of Medium-chain Triglycerides Emulsification on Ketogenesis and Adverse Effects in Human Adults
Lower brain glucose uptake is present before the onset of cognitive deterioration and may increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized and are ketogenic. Large doses of MCT oil are linked to gastro-intestinal side effects due to incomplete absorption so the investigators examined whether homogenisation into a skim milk matrix (MCT-H) would both improve ketogenesis and reduce side-effects compared to MCT taken without homogenisation into a matrix (bulk MCT [MCT-B]).
Hypotheses: (i) MCT-H will be better absorbed compared to MCT-B, so MCT-H will result in higher ketonemia and lower side effects in healthy adults. (ii) The effects of MCT-B and MCT-H on ketogenesis will be dose-dependent.
- Conditions
- Healthy
- Being tested
- MCT oil 10g, MCT homogenate 10g, Control, MCT oil 20g, MCT homogenate 20g
- Keywords
- Medium-chain triglycerides, Metabolism, Ketones, Lipids, Emulsification
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCT oil 10gDietary supplement
10 g of pure MCT oil mixed with skim milk in a standardized breakfast
MCT homogenate 10gDietary supplement
10g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast
ControlDietary supplement
vehicule (skim milk) with a standardized breakfast
MCT oil 20gDietary supplement
20g of pure MCT oil mixed with skim milk in a standardized breakfast
MCT homogenate 20gDietary supplement
20g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast
MCT oil 30gDietary supplement
30g of 100% pure MCT oil mixed with skim milk in a standardized breakfast
MCT homogenate 30gDietary supplement
30g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast
| Study group | Role | What they receive |
|---|---|---|
| Healthy participant | Other | Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion) Receives: Dietary Supplement: MCT oil 10g; Dietary Supplement: MCT homogenate 10g; Dietary Supplement: Control; Dietary Supplement: MCT oil 20g; Dietary Supplement: MCT homogenate 20g; Dietary Supplement: MCT oil 30g; Dietary Supplement: MCT homogenate 30g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Ketone Concentration
Average of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements
Measured: Average of every 30 minutes for 4 hours following intake of supplement
Secondary outcomes (4)
Plasma Glucose Concentration
average of glucose measured every 30 minutes during the four hour of each metabolic day
Measured: Average of every 30 minutes for 4 hours following intake of supplement
Plasma Free Fatty Acids Concentration
average of free fatty acids measured every 30 minutes during the four hour fo each metabolic day
Measured: average of 4 hours following intake of supplement
Plasma Insuline Concentration
Average of insulin measured evey 30 minutes during the 4 hours of each metabolic day
Measured: average of 4 hours following intake of supplement
Number of Participants With Side Effects for Each Visit
If participant had any side effect (mild or moderate) at least one time during the day.
Measured: During the 4 hours following intake of supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Model description
- Each participant underwent 7 metabolic day (1-day visit), each visit separate by a minimum of 3 day
- 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 C Cunnane, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409927
- Sponsor's protocol ID
- 2014-391
- Status last verified
- May 2015
- First submitted
- 27 Mar 2015
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Courchesne-Loyer A, Lowry CM, St-Pierre V, Vandenberghe C, Fortier M, Castellano CA, Wagner JR, Cunnane SC. Emulsification Increases the Acute Ketogenic Effect and Bioavailability of Medium-Chain Triglycerides in Humans: Protein, Carbohydrate, and Fat Metabolism. Curr Dev Nutr. 2017 Jun 21;1(7):e000851. doi: 10.3945/cdn.117.000851. eCollection 2017 Jul.
PubMed 29955713
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medium-chain Triglycerides Emulsification on Ketogenesis and Adverse Effects in Human Adults
- ClinicalTrials.gov ID
- NCT02409927
- Acronym / sponsor ID
- 2014-391
- Conditions
- Healthy
- Keywords
- Medium-chain triglycerides, Metabolism, Ketones, Lipids, Emulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lower brain glucose uptake is present before the onset of cognitive deterioration and may increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized and are ketogenic. Large doses of MCT oil are linked to gastro-intestinal side effects due to incomplete absorption so the investigators examined whether homogenisation into a skim milk matrix (MCT-H) would both improve ketogenesis and reduce side-effects compared to MCT taken without homogenisation into a matrix (bulk MCT [MCT-B]).
Hypotheses: (i) MCT-H will be better absorbed compared to MCT-B, so MCT-H will result in higher ketonemia and lower side effects in healthy adults. (ii) The effects of MCT-B and MCT-H on ketogenesis will be dose-dependent.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant underwent 7 metabolic day (1-day visit), each visit separate by a minimum of 3 day
| Arm | Type | Receives |
|---|---|---|
| Healthy participant | Other | Dietary Supplement: MCT oil 10g, Dietary Supplement: MCT homogenate 10g, Dietary Supplement: Control, Dietary Supplement: MCT oil 20g, Dietary Supplement: MCT homogenate 20g, Dietary Supplement: MCT oil 30g, Dietary Supplement: MCT homogenate 30gEach participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 years or more
Key exclusion criteria (9 listed)
- smoker
- pregnancy or breastfeeding
- diabetes or insulin resistance
- uncontrolled thyroid disease, hepatic or renal disease
- uncontrolled high blood pressure
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 |
|---|---|---|
| MCT oil 10g10 g of pure MCT oil mixed with skim milk in a standardized breakfast | Dietary supplement | Healthy participant |
| MCT homogenate 10g10g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast | Dietary supplement | Healthy participant |
| Controlvehicule (skim milk) with a standardized breakfast | Dietary supplement | Healthy participant |
| MCT oil 20g20g of pure MCT oil mixed with skim milk in a standardized breakfast | Dietary supplement | Healthy participant |
| MCT homogenate 20g20g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast | Dietary supplement | Healthy participant |
| MCT oil 30g30g of 100% pure MCT oil mixed with skim milk in a standardized breakfast | Dietary supplement | Healthy participant |
| MCT homogenate 30g30g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast | Dietary supplement | Healthy participant |
Primary outcome
Plasma Ketone Concentration
Time frame: Average of every 30 minutes for 4 hours following intake of supplement
Average of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements
4 secondary outcomes
Plasma Glucose Concentration
Time frame: Average of every 30 minutes for 4 hours following intake of supplement
Plasma Free Fatty Acids Concentration
Time frame: average of 4 hours following intake of supplement
Plasma Insuline Concentration
Time frame: average of 4 hours following intake of supplement
Number of Participants With Side Effects for Each Visit
Time frame: During the 4 hours following intake of supplement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29955713Courchesne-Loyer A, Lowry CM, St-Pierre V, Vandenberghe C, Fortier M, Castellano CA, Wagner JR, Cunnane SC. Emulsification Increases the Acute Ketogenic Effect and Bioavailability of Medium-Chain Triglycerides in Humans: Protein, Carbohydrate, and Fat Metabolism. Curr Dev Nutr. 2017 Jun 21;1(7):e000851. doi: 10.3945/cdn.117.000851. eCollection 2017 Jul.
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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 C Cunnane, PhD principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
A study testing MCT oil 10g, MCT homogenate 10g and MCT oil 20g in people with Healthy, run by Université de Sherbrooke.
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 9 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 17 Dec 2018). 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 Concentration (time frame: Average of every 30 minutes for 4 hours following intake of supplement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409927, which also lists 1 linked publication.
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 11 Feb 2019.