Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS
NCT ID: NCT06426134
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2024-12-01
2026-04-01
Brief Summary
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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)
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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dGK
1x50 g dGK ketone drink
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate)
1x50g ingestion of pure dGK
isocaloric carb control
1x isocaloric carbohydrate control drink
Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride
Isocaloric carbohydrate control (active control)
Interventions
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(R)-3-hydroxybutyl (R)-3-hydroxybutyrate)
1x50g ingestion of pure dGK
Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride
Isocaloric carbohydrate control (active control)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years old
* Receiving standard care (including antipsychotic and mood stabilizing medication)
* Mentally competent to give informed consent:
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Parnassia Groep
OTHER
The University of Texas at Dallas
OTHER
University of Alberta
OTHER
EnLiSense
UNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Karin Huizer
Principal Investigator; MD, PhD
Principal Investigators
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Karin Huizer, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Parnassia Groep
Locations
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Amsterdam UMC, dept. Psychiatry
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Dielemans DA, Yurtkap Y, van der Pluijm M, Soeters MR, Oranje B, Smit DJ, Ziermans T, van Tricht MJ, Muthukumar S, Prasad S, van der Mieden van Opmeer RL, Dekeyster E, Kamperman AM, Dyck JR, Rosema BS, Hoekstra R, Kupka RW, de Haan L, van Beveren NJ, Huizer K. The Effect of Exogenous Ketones on Signs and Symptoms of Schizophrenia Spectrum and Bipolar Disorders: Study Protocol for a Triple-Blind, Randomized, Controlled Crossover Pilot Study. Curr Dev Nutr. 2025 May 24;9(6):107480. doi: 10.1016/j.cdnut.2025.107480. eCollection 2025 Jun.
Other Identifiers
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2024.0100
Identifier Type: OTHER
Identifier Source: secondary_id
NL83836.018.23
Identifier Type: -
Identifier Source: org_study_id