PharmacokineticsNCT04389983
Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil
A study testing Medium Chain Triglyceride oil in people with Pharmacokinetics, run by University of Alberta at 1 site in Canada.
Trial summary
Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Medium Chain Triglyceride oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2019to 15 Apr 2020
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult, healthy or with AD
Who cannot join
- unable to attend all study days
- coconut allergy
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil
Read the detailed description
Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil in three study populations: <65 year healthy, 65 and older healthy, and Alzheimer's disease.
Each subject attends for 4 study days, receiving incrementally larger MCT doses at each visit for 0g, to 14g, to 28g to 42g.
- Conditions
- Pharmacokinetics
- Being tested
- Medium Chain Triglyceride oil
- Keywords
- MCT oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium Chain Triglyceride oilDietary supplement
Bulletproof Braine Octane MCT oil
| Study group | Role | What they receive |
|---|---|---|
| Healthy, under 65 years | Active comparator | Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter (All MCT doses administered as a single dose at time 0) Receives: Dietary Supplement: Medium Chain Triglyceride oil |
| Healthy, over 65 years | Active comparator | Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter.
(All MCT doses administered as a single dose at time 0) Receives: Dietary Supplement: Medium Chain Triglyceride oil |
| Alzheimer's Disease subjects | Active comparator | Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter.
(All MCT doses administered as a single dose at time 0) Receives: Dietary Supplement: Medium Chain Triglyceride oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Calculation of Cmax to varying doses in each subject and in different study arms.
Measured: 3 months
Time to maximum plasma concentration (tmax)
Calculation of tmax to varying doses in each subject and in different study arms.
Measured: 3 months
Area under the curve (AUC)
Calculation of AUC to varying doses in each subject and in different study arms.
Measured: 3 months
Secondary outcomes (4)
weight
measured in kg
Measured: 3months
height
measured in cm
Measured: 3 months
BMI
Calculated BMI (ht/m2)
Measured: 3months
Body fat
% measured by bioimpedence scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start2 May 2019
- Primary completion24 May 2019
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Juby, University of Alberta
- Investigators
- Angela Juby, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389983
- Sponsor's protocol ID
- 00087958
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil
- ClinicalTrials.gov ID
- NCT04389983
- Acronym / sponsor ID
- 00087958
- Conditions
- Pharmacokinetics
- Keywords
- MCT oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 15 May 2020 (actual)
- 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.
Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil
Detailed description
Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil in three study populations: <65 year healthy, 65 and older healthy, and Alzheimer's disease.
Each subject attends for 4 study days, receiving incrementally larger MCT doses at each visit for 0g, to 14g, to 28g to 42g.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy, under 65 years | Active comparator | Dietary Supplement: Medium Chain Triglyceride oilFour study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter (All MCT doses administered as a single dose at time 0) |
| Healthy, over 65 years | Active comparator | Dietary Supplement: Medium Chain Triglyceride oilFour study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter. (All MCT doses administered as a single dose at time 0) |
| Alzheimer's Disease subjects | Active comparator | Dietary Supplement: Medium Chain Triglyceride oilFour study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter. (All MCT doses administered as a single dose at time 0) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult, healthy or with AD
Key exclusion criteria (3 listed)
- unable to attend all study days
- coconut allergy
- Diabetes
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 |
|---|---|---|
| Medium Chain Triglyceride oilBulletproof Braine Octane MCT oil | Dietary supplement | Alzheimer's Disease subjects, Healthy, over 65 years, Healthy, under 65 years |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 3 months
Calculation of Cmax to varying doses in each subject and in different study arms.
Time to maximum plasma concentration (tmax)
Time frame: 3 months
Calculation of tmax to varying doses in each subject and in different study arms.
Area under the curve (AUC)
Time frame: 3 months
Calculation of AUC to varying doses in each subject and in different study arms.
4 secondary outcomes
weight
Time frame: 3months
height
Time frame: 3 months
BMI
Time frame: 3months
Body fat
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: No
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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.
Angela Juby principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium Chain Triglyceride oil in people with Pharmacokinetics, run by University of Alberta 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 3 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 15 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum plasma concentration (Cmax) (time frame: 3 months). The study lists 3 primary outcomes in all. 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 15 May 2020.