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Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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)
Official title: Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-12-01
Completion Date
2026-04-01
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate)
1x50g ingestion of pure dGK
Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride
Isocaloric carbohydrate control (active control)
Locations (1)
Amsterdam UMC, dept. Psychiatry
Amsterdam, North Holland, Netherlands