Effects of ketone ester supplementation on brain ketone levels
Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid
This study is testing if taking a ketone supplement can change the levels of a specific ketone in the brain and blood of people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06318299 on ClinicalTrials.gov |
What this trial studies
This study investigates how exogenous ketone ester supplementation affects the concentration of 3-hydroxybutyrate (3-OHB) in human cerebrospinal fluid (CSF) and blood. Participants will receive either a ketone ester or a placebo before undergoing a lumbar puncture to measure the 3-OHB levels. The study aims to determine the ratio of 3-OHB in CSF compared to blood and the optimal timing for sampling after supplementation. This research is crucial as it addresses a gap in understanding how ketone bodies are utilized by the brain in humans.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who are scheduled for an elective lumbar puncture at Aarhus University Hospital.
Not a fit: Patients with severe neuroinflammation or those on specific diets affecting ketone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of ketone metabolism in the brain, potentially leading to new dietary or therapeutic strategies for neurological conditions.
How similar studies have performed: While studies on ketone bodies exist, this specific approach of measuring 3-OHB in both blood and CSF in humans is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Simon Kjær Simonsen, MD
- Email: simkjr@clin.au.dk
- Phone: +45 28769491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.