Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS
Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
24 participants
Dec 1, 2024
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
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
1x50g ingestion of pure dGK
Isocaloric carbohydrate control (active control)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06426134