Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-12
Brief Title:
Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KetoBrain
Brief Summary:
It is well established that the brain is capable of consuming ketone bodies especially during low glucose availability eg 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 CSFblood 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
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 CSFblood 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None