Trials / Recruiting
RecruitingNCT06426134
Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS
Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2024-05-23
- Last updated
- 2025-12-16
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06426134. Inclusion in this directory is not an endorsement.