Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS (KISSeS)

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

Status: Enrolling

Conditions: Psychosis; Bipolar and Related Disorders; Schizophrenia and Related Disorders; Manic Episode; Depressive Episode

Treatments: Other: Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride; Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate)

Study type: Interventional

Funder types: Other

Identifiers

NCT06426134

NL83836.018.23

Details and patient eligibility

About

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?

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; after each drink:

   • EEG 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. 4x/day, only on both intervention days)

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

dGK

Experimental group

Description:

1x50 g dGK ketone drink

Treatment:

Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate)

isocaloric carb control

Active Comparator group

Description:

1x isocaloric carbohydrate control drink

Treatment:

Other: Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride