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

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

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