Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-28 @ 10:26 PM
Study NCT ID:
NCT06426134
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Organization:
Study Overview
Official Title:
Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KISSeS
Brief 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)
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024.0100 | OTHER | METC AUMC | View |