Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS

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)

Conditions

• Schizophrenia and Related Disorders
• Psychosis
• Bipolar and Related Disorders
• Manic Episode
• Depressive Episode

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)

Sponsors & Collaborators

• Parnassia Groep

  collaborator OTHER

• The University of Texas at Dallas

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• EnLiSense

  collaborator UNKNOWN

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

  lead OTHER

Principal Investigators

• Karin Huizer, MD/PhD · Parnassia Groep

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2026-04-17

Completion

2026-04-17

Countries

• Netherlands

Study Locations