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Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid

Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06318299
Acronym
KetoBrain
Enrollment
24
Registered
2024-03-19
Start date
2024-06-20
Completion date
2025-03-18
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketosis

Keywords

Cerebrospinal Fluid, Brain-Derived Neurotrophic Factor, Point-of-Care Testing, Ketone Bodies, Ketone body adminstration

Brief 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. 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

Interventions

DIETARY_SUPPLEMENTKetone Ester

Commercially available ketone ester drink (KetoneAid, Virginia, USA)

OTHERPlacebo

Taste and appearance matched noncaloric placebo drink

Sponsors

Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
3-OHB CSF/blood ratio1-2 hours after ingestionAfter oral ingestion of 30 g ketone ester drink or placebo drink

Secondary

MeasureTime frameDescription
CSF 3-OHB concentrations, Mass Spectrometry1-2 hours after ingestionAfter oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection
CSF glucose concentrations1-2 hours after ingestionAfter oral ingestion of 30 g ketone ester drink or placebo drink
Blood 3-OHB concentrations1-2 hours after ingestionAfter oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
CSF 3-OHB concentrations, POCT1-2 hours after ingestionAfter oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Blood glucose concentrations1-2 hours after ingestionAfter oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Plasma BDNF concentrations1-2 hours after ingestionAfter oral ingestion of 30 g ketone ester drink or placebo drink
Plasma 3-OHB concentrations1-2 hours after ingestionAfter oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026