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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

Locations
Other Locations
Netherlands
Amsterdam UMC, dept. Psychiatry
RECRUITING
Amsterdam
Contact Information
Primary
Karin Huizer, MD/PhD
k.huizer@parnassiagroep.nl
+31683048776
Backup
Nico Beveren, van, MD/PhD
n.beveren@parnassiagroep.nl
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 24
Treatments
Experimental: dGK
1x50 g dGK ketone drink
Active_comparator: isocaloric carb control
1x isocaloric carbohydrate control drink
Related Therapeutic Areas
Sponsors
Collaborators: The University of Texas at Dallas, EnLiSense, University of Alberta, Parnassia Groep
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov