Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid
- Conditions
- Ketosis
- Interventions
- Dietary Supplement: Ketone EsterOther: Placebo
- Registration Number
- NCT06318299
- Lead Sponsor
- University of Aarhus
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketone 2 hours Ketone Ester Ketone ester drink administered two hours before elective lumbar puncture Ketone 1 hour Ketone Ester Ketone ester drink administered one hour before elective lumbar puncture Placebo 1 hour Placebo Placebo drink administered one hour before elective lumbar puncture
- Primary Outcome Measures
Name Time Method 3-OHB CSF/blood ratio 1-2 hours after ingestion After oral ingestion of 30 g ketone ester drink or placebo drink
- Secondary Outcome Measures
Name Time Method Plasma BDNF concentrations Before ingestion Before oral ingestion of 30 g ketone ester drink or placebo drink
CSF 3-OHB concentrations, POCT 1-2 hours after ingestion After oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Blood 3-OHB concentrations Before ingestion Before oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Plasma 3-OHB concentrations Before ingestion After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection
CSF glucose concentrations 1-2 hours after ingestion After oral ingestion of 30 g ketone ester drink or placebo drink
CSF 3-OHB concentrations, Mass Spectrometry 1-2 hours after ingestion After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection
Blood glucose concentrations Before ingestion Before oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus, Denmark