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

Ketosis Clinical Trial

— KetoBrain  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06318299
• Other study ID #: 109227
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of Aarhus
• Contact: Simon Kjær Simonsen, MD
• Phone: +45 28769491
• Email: simkjr[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketosis

Intervention

Dietary Supplement:
• Ketone Ester
Commercially available ketone ester drink (KetoneAid, Virginia, USA)

Other:
• Placebo
Taste and appearance matched noncaloric placebo drink

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-OHB CSF/blood ratio	After oral ingestion of 30 g ketone ester drink or placebo drink	1-2 hours after ingestion
Secondary	CSF 3-OHB concentrations, POCT	After oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)	1-2 hours after ingestion
Secondary	CSF 3-OHB concentrations, Mass Spectrometry	After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection	1-2 hours after ingestion
Secondary	CSF glucose concentrations	After oral ingestion of 30 g ketone ester drink or placebo drink	1-2 hours after ingestion
Secondary	Blood 3-OHB concentrations	After oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)	1-2 hours after ingestion
Secondary	Plasma 3-OHB concentrations	After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection	1-2 hours after ingestion
Secondary	Blood glucose concentrations	After oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)	1-2 hours after ingestion
Secondary	Plasma BDNF concentrations	After oral ingestion of 30 g ketone ester drink or placebo drink	1-2 hours after ingestion
Secondary	Blood 3-OHB concentrations	Before oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)	Before ingestion
Secondary	Plasma 3-OHB concentrations	After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection	Before ingestion
Secondary	Blood glucose concentrations	Before oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT)	Before ingestion
Secondary	Plasma BDNF concentrations	Before oral ingestion of 30 g ketone ester drink or placebo drink	Before ingestion