Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06318299
Other study ID # 109227
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Active, not recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A
Completed NCT04817176 - MI-CBT Adherence Program for Lifestyle Interventions in Older Adults Early Phase 1
Completed NCT04565444 - Ketones and Muscle Protein Synthesis N/A
Not yet recruiting NCT06418074 - Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity N/A
Not yet recruiting NCT03954665 - Ketone Supplementation and Exercise Performance N/A
Active, not recruiting NCT06097754 - Intermittent Exogenous Ketosis (IEK) at High Altitude N/A
Terminated NCT03790436 - Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet N/A
Completed NCT03299543 - Comparison Between Breath Acetone and Blood Beta-Hydroxybutyrate
Recruiting NCT04004676 - Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise N/A
Not yet recruiting NCT03659825 - Ketone Esters for Optimization of Cognitive Performance in Hypoxia N/A
Active, not recruiting NCT04156477 - Markers of Appetite Regulation During Exogenous Ketosis N/A
Completed NCT04130724 - Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
Recruiting NCT04594265 - Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure Phase 2
Not yet recruiting NCT04576026 - Exogenous Ketone Supplementation and Cognitive Function During Exercise N/A
Completed NCT05558488 - The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response N/A
Recruiting NCT03564002 - Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
Completed NCT04309214 - Market Research - Acceptability Study for New MCT Fat Products N/A
Completed NCT05588427 - Effect of Ketone Ester Supplementation on Hypoxic Tolerance N/A
Recruiting NCT05656339 - Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers N/A