The effect of exogenous ketones on signs and symptoms of schizophrenia spectrum and bipolar disorders: study protocol for a triple-blind, randomized, controlled cross-over pilot study DOI

Daphne AM Dielemans,

Y Yurtkap,

Marieke van der Pluijm

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2025, Volume and Issue: unknown

Published: March 5, 2025

Abstract Introduction Inflammation, oxidative stress, and bioenergetic dysfunction are proposed underlying mechanisms of schizophrenia spectrum disorders (SSD) bipolar (BD), contributing to the largely untreated cognitive negative symptoms in these conditions. Ketone bodies may offer a therapeutic option for through their positive effects on aforementioned mechanisms. Exogenous ketones like ketone esters (KE) provide means quickly induce ketosis without dietary restrictions, though SSD BD have not yet been investigated. Here, we describe study protocol an ongoing triple-blind, randomized controlled crossover trial single ingestion KE signs BD. Methods A total 24 patients (12 SSD, 12 BD) receiving inpatient care at Amsterdam UMC will be included study. Patients ingest dose ((R)-3-hydroxybutyl-(R)-3-hydroxybutyrate deltaG® - dGK) isocaloric carbohydrate control with washout period three days between drinks. The primary outcome is change pre-pulse inhibition startle reflex (PPI) induced by dGK compared control. Secondary outcomes include resting-state EEG, P3B amplitude, performance, metabolic, immune, stress circadian rhythm parameters. Feasibility potential side also assessed. Discussion Our current offers valuable preliminary data patients. It can foundation future research into alleviating improving functional disorders. Trial registration www.ClinicalTrials.gov , ID: NCT06426134 .

Language: Английский

The effect of exogenous ketones on signs and symptoms of schizophrenia spectrum and bipolar disorders: study protocol for a triple-blind, randomized, controlled cross-over pilot study DOI

Daphne AM Dielemans,

Y Yurtkap,

Marieke van der Pluijm

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2025, Volume and Issue: unknown

Published: March 5, 2025

Abstract Introduction Inflammation, oxidative stress, and bioenergetic dysfunction are proposed underlying mechanisms of schizophrenia spectrum disorders (SSD) bipolar (BD), contributing to the largely untreated cognitive negative symptoms in these conditions. Ketone bodies may offer a therapeutic option for through their positive effects on aforementioned mechanisms. Exogenous ketones like ketone esters (KE) provide means quickly induce ketosis without dietary restrictions, though SSD BD have not yet been investigated. Here, we describe study protocol an ongoing triple-blind, randomized controlled crossover trial single ingestion KE signs BD. Methods A total 24 patients (12 SSD, 12 BD) receiving inpatient care at Amsterdam UMC will be included study. Patients ingest dose ((R)-3-hydroxybutyl-(R)-3-hydroxybutyrate deltaG® - dGK) isocaloric carbohydrate control with washout period three days between drinks. The primary outcome is change pre-pulse inhibition startle reflex (PPI) induced by dGK compared control. Secondary outcomes include resting-state EEG, P3B amplitude, performance, metabolic, immune, stress circadian rhythm parameters. Feasibility potential side also assessed. Discussion Our current offers valuable preliminary data patients. It can foundation future research into alleviating improving functional disorders. Trial registration www.ClinicalTrials.gov , ID: NCT06426134 .

Language: Английский

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