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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone 1 hour | Active Comparator | Ketone ester drink administered one hour before elective lumbar puncture |
|
| Ketone 2 hours | Active Comparator | Ketone ester drink administered two hours before elective lumbar puncture |
|
| Placebo 1 hour | Placebo Comparator | Placebo drink administered one hour before elective lumbar puncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Ester | Dietary Supplement | Commercially available ketone ester drink (KetoneAid, Virginia, USA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-OHB CSF/blood ratio | After oral ingestion of 30 g ketone ester drink or placebo drink | 1-2 hours after ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| CSF 3-OHB concentrations, Mass Spectrometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Møller, Professor | Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C524675 | formic acid 4-(3-oxobutyl)phenyl ester |
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| Placebo | Other | Taste and appearance matched noncaloric placebo drink |
|
After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection
| 1-2 hours after ingestion |
| CSF glucose concentrations | After oral ingestion of 30 g ketone ester drink or placebo drink | 1-2 hours after ingestion |
| 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 |
| Plasma 3-OHB concentrations | After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection | 1-2 hours after ingestion |
| 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 |
| Plasma BDNF concentrations | After oral ingestion of 30 g ketone ester drink or placebo drink | 1-2 hours after ingestion |
| Blood 3-OHB concentrations | Before oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT) | Before ingestion |
| Plasma 3-OHB concentrations | After oral ingestion of 30 g ketone ester drink or placebo drink, Mass Spectrometry Detection | Before ingestion |
| Blood glucose concentrations | Before oral ingestion of 30 g ketone ester drink or placebo drink, Point-of-care testing (POCT) | Before ingestion |
| Plasma BDNF concentrations | Before oral ingestion of 30 g ketone ester drink or placebo drink | Before ingestion |