RecruitingNot ApplicableNCT06426134

Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS

Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

24 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD). The main questions it aims to answer are: Does a ketone drink improve information processing in patients with SSD/BD? Other questions it aims to answer are: Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Does a ketone drink affect circadian rhythm in patients with SSD/BD? Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over'). Participants will: 1. drink a ketone drink and (after a wash-out period) an isocaloric control drink (randomized order); after each drink: * EEG/EMG to determine information-processing parameters (PPI and P300) * cognitive tests * visual analog scale of mood, energy levels, ability to focus * indirect calorimetry to determine use of energy substrate * blood draws 2. for 5 consecutive days: * wear a continuous glucose monitor (CGM) * wear a non-invasive passive sweat biomarker sensor (EnLiSense device) * register a diet and nicotine diary * saliva sampling (max. 5x/day)


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder)
  • Age \>= 18 years old
  • Receiving standard care (including antipsychotic and mood stabilizing medication)
  • Mentally competent to give informed consent:

Exclusion Criteria10

  • Substance use as cause of psychosis or (hypo)mania
  • Substance use (other than nicotine) in the week prior to study onset
  • Intellectual disability
  • Diabetes mellitus (type 1 or type 2)
  • Metabolic disease impacting ketone metabolism (NB: these are rare disorders diagnosed during childhood)
  • Liver disease
  • Kidney disease
  • Cardiovascular disease
  • Pregnancy
  • Breastfeeding

Interventions

DIETARY_SUPPLEMENT(R)-3-hydroxybutyl (R)-3-hydroxybutyrate)

1x50g ingestion of pure dGK

OTHERMaltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride

Isocaloric carbohydrate control (active control)


Locations(1)

Amsterdam UMC, dept. Psychiatry

Amsterdam, North Holland, Netherlands

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NCT06426134


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