KetosisKetoBrainNCT06318299
Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid
A study testing Ketone Ester in people with Ketosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketosis
- What is being tested?
- Ketone Ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jun 2024to 18 Mar 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All sexes
- Referred to undergo an elective lumbar puncture procedure in the outpatient clinic at Department of Neurology, Aarhus University Hospital.
- Age 18-80 years
- Written and oral consent
Who cannot join
- Referred to the clinic suspecting severe neuroinflammation
- Special diet habits, including ketogenic diet, fasting, intermittent fasting etc.
- Daily use of insulin or other medication affecting blood glucose and/or glucose metabolism
- Not able to speak or understand Danish and/or give written and oral consent
Trial locations and contacts
1 site in 1 country.
About this study
It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies.
Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier.
Read more
To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study.
Aims:
- The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint
- The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling
- If concentration measurements by point-of-care testing are non-inferior to mass spectrometry
- If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels
- Conditions
- Ketosis
- Being tested
- Ketone Ester, Placebo
- Keywords
- Cerebrospinal Fluid, Brain-Derived Neurotrophic Factor, Point-of-Care Testing, Ketone Bodies, Ketone body adminstration
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone EsterDietary supplement
Commercially available ketone ester drink (KetoneAid, Virginia, USA)
PlaceboOther
Taste and appearance matched noncaloric placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Ketone 1 hour | Active comparator | Ketone ester drink administered one hour before elective lumbar puncture Receives: Dietary Supplement: Ketone Ester |
| Ketone 2 hours | Active comparator | Ketone ester drink administered two hours before elective lumbar puncture Receives: Dietary Supplement: Ketone Ester |
| Placebo 1 hour | Placebo comparator | Placebo drink administered one hour before elective lumbar puncture Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-OHB CSF/blood ratio
After oral ingestion of 30 g ketone ester drink or placebo drink
Measured: 1-2 hours after ingestion
Secondary outcomes (11)
CSF 3-OHB concentrations, POCT
After oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Measured: 1-2 hours after ingestion
CSF 3-OHB concentrations, Mass Spectrometry
After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection
Measured: 1-2 hours after ingestion
CSF glucose concentrations
After oral ingestion of 30 g ketone ester drink or placebo drink
Measured: 1-2 hours after ingestion
Blood 3-OHB concentrations
After oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Measured: 1-2 hours after ingestion
Plasma 3-OHB concentrations
After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection
Measured: 1-2 hours after ingestion
Blood glucose concentrations
After oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Measured: 1-2 hours after ingestion
Plasma BDNF concentrations
After oral ingestion of 30 g ketone ester drink or placebo drink
Measured: 1-2 hours after ingestion
Blood 3-OHB concentrations
Before oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Measured: Before ingestion
Plasma 3-OHB concentrations
After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection
Measured: Before ingestion
Blood glucose concentrations
Before oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Measured: Before ingestion
Plasma BDNF concentrations
Before oral ingestion of 30 g ketone ester drink or placebo drink
Measured: Before ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start20 Jun 2024
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Møller, Professor, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318299
- Sponsor's protocol ID
- 109227
- Acronym
- KetoBrain
- Status last verified
- Oct 2024
- First submitted
- 12 Mar 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid
- ClinicalTrials.gov ID
- NCT06318299
- Acronym / sponsor ID
- KetoBrain / 109227
- Conditions
- Ketosis
- Keywords
- Cerebrospinal Fluid, Brain-Derived Neurotrophic Factor, Point-of-Care Testing, Ketone Bodies, Ketone body adminstration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 19 Mar 2024 (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.
It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies.
Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier.
To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study.
Aims:
- The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint
- The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling
- If concentration measurements by point-of-care testing are non-inferior to mass spectrometry
- If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketone 1 hour | Active comparator | Dietary Supplement: Ketone EsterKetone ester drink administered one hour before elective lumbar puncture |
| Ketone 2 hours | Active comparator | Dietary Supplement: Ketone EsterKetone ester drink administered two hours before elective lumbar puncture |
| Placebo 1 hour | Placebo comparator | Other: PlaceboPlacebo drink administered one hour before elective lumbar puncture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All sexes
- Referred to undergo an elective lumbar puncture procedure in the outpatient clinic at Department of Neurology, Aarhus University Hospital.
- Age 18-80 years
- Written and oral consent
Key exclusion criteria (4 listed)
- Referred to the clinic suspecting severe neuroinflammation
- Special diet habits, including ketogenic diet, fasting, intermittent fasting etc.
- Daily use of insulin or other medication affecting blood glucose and/or glucose metabolism
- Not able to speak or understand Danish and/or give written and oral consent
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 |
|---|---|---|
| Ketone EsterCommercially available ketone ester drink (KetoneAid, Virginia, USA) | Dietary supplement | Ketone 1 hour, Ketone 2 hours |
| PlaceboTaste and appearance matched noncaloric placebo drink | Other | Placebo 1 hour |
Primary outcome
3-OHB CSF/blood ratio
Time frame: 1-2 hours after ingestion
After oral ingestion of 30 g ketone ester drink or placebo drink
11 secondary outcomes
CSF 3-OHB concentrations, POCT
Time frame: 1-2 hours after ingestion
CSF 3-OHB concentrations, Mass Spectrometry
Time frame: 1-2 hours after ingestion
CSF glucose concentrations
Time frame: 1-2 hours after ingestion
Blood 3-OHB concentrations
Time frame: 1-2 hours after ingestion
Plasma 3-OHB concentrations
Time frame: 1-2 hours after ingestion
Blood glucose concentrations
Time frame: 1-2 hours after ingestion
Plasma BDNF concentrations
Time frame: 1-2 hours after ingestion
Blood 3-OHB concentrations
Time frame: Before ingestion
Plasma 3-OHB concentrations
Time frame: Before ingestion
Blood glucose concentrations
Time frame: Before ingestion
Plasma BDNF concentrations
Time frame: Before ingestion
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 28 Aug 2025.
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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.
Niels Møller, Professor study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Ester in people with Ketosis, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 4 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 28 Aug 2025. 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 Denmark. 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?
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?
3-OHB CSF/blood ratio (time frame: 1-2 hours after ingestion). 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 28 Aug 2025.