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RECRUITING
NCT06426134
NA

Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS

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

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

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

1x50g ingestion of pure dGK

OTHER

Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride

Isocaloric carbohydrate control (active control)

Locations (1)

Amsterdam UMC, dept. Psychiatry

Amsterdam, North Holland, Netherlands