ClinicalTrials.Veeva

Menu

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

A

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

Status

Not yet 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

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

Trial contacts and locations

0

Loading...

Central trial contact

Nico Beveren, van, MD/PhD; Karin Huizer, MD/PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems