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NCT06318299: KetoBrain
Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid
NA trial testing Ketone Ester in Ketosis in 24 participants. Completed in 18 March 2025.
18 March 2025
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 20 June 2024 |
| Primary completion | 18 March 2025 |
| Estimated completion | 18 March 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Ketone Ester
- Placebo
Conditions studied
- Ketosis — all drugs for Ketosis →
Sponsor
University of Aarhus
Who can join
Adults 18 to 80, any sex, with Ketosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06318299
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ketone Ester
Trials testing the same drug.
- NCT05888506 — Ketone Ester Supplementation and Nocturnal Blood Pressure · NA · completed
- NCT03729934 — Ketones Supplementation and Postprandial Lipemia · NA · withdrawn
- NCT03659825 — Ketone Esters for Optimization of Cognitive Performance in Hypoxia · NA · unknown
Other recruiting trials for Ketosis
Currently open trials in the same condition.
- NCT06815237 — Effects of Ketone Supplement and Alcohol on Brain Metabolism · Phase 2, PHASE3 · recruiting
- NCT06338969 — The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis · NA · recruiting
- NCT05924295 — Variations in Ketone Metabolism · NA · recruiting
Other University of Aarhus trials
Trials by the same sponsor.
- NCT07209540 — European LUpuS Inception-Cohort Developing initiATivE · not yet recruiting
- NCT07317401 — Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Post-Viral Myalgic Encephalo · NA · not yet recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
- NCT07528339 — Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK) · not yet recruiting
- NCT07451028 — Effect of an Oral Neuromuscular Training Device on Dysphagia · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06318299 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06318299.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing