NCT06318299

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2025

Completed
Last Updated

August 28, 2025

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

March 12, 2024

Last Update Submit

August 21, 2025

Conditions

Ketosis

Keywords

Cerebrospinal FluidBrain-Derived Neurotrophic FactorPoint-of-Care TestingKetone BodiesKetone body adminstration

Outcome Measures

Primary Outcomes (1)

  • 3-OHB CSF/blood ratio

    After oral ingestion of 30 g ketone ester drink or placebo drink

    1-2 hours after ingestion

Secondary Outcomes (11)

  • CSF 3-OHB concentrations, POCT

    1-2 hours after ingestion

  • CSF 3-OHB concentrations, Mass Spectrometry

    1-2 hours after ingestion

  • CSF glucose concentrations

    1-2 hours after ingestion

  • Blood 3-OHB concentrations

    1-2 hours after ingestion

  • Plasma 3-OHB concentrations

    1-2 hours after ingestion

  • +6 more secondary outcomes

Study Arms (3)

Ketone 1 hour

ACTIVE COMPARATOR

Ketone ester drink administered one hour before elective lumbar puncture

Dietary Supplement: Ketone Ester

Ketone 2 hours

ACTIVE COMPARATOR

Ketone ester drink administered two hours before elective lumbar puncture

Dietary Supplement: Ketone Ester

Placebo 1 hour

PLACEBO COMPARATOR

Placebo drink administered one hour before elective lumbar puncture

Other: Placebo

Interventions

Ketone EsterDIETARY_SUPPLEMENT

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

Ketone 1 hourKetone 2 hours
PlaceboOTHER

Taste and appearance matched noncaloric placebo drink

Placebo 1 hour

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Ketosis

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Niels Møller, Professor

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

June 20, 2024

Primary Completion

March 18, 2025

Study Completion

March 18, 2025

Last Updated

August 28, 2025

Record last verified: 2024-10

Locations

DK(1)