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

NCT06318299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-28

No results posted yet for this study

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

Conditions

  • Ketosis

Interventions

DIETARY_SUPPLEMENT

Ketone Ester

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

OTHER

Placebo

Taste and appearance matched noncaloric placebo drink

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Niels Møller, Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2025-03-18
Completion
2025-03-18

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06318299 on ClinicalTrials.gov