Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-08
Brief Title:
Ketosis Impact on Signs Symptoms of Schizophrenia and Bipolar disorderS
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 SSDBD
Other questions it aims to answer are
Does a ketone drink improve cognitive functioning in patients with SSDBD Does a ketone drink improve metabolism and inflammation in patients with SSDBD
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 4xday only on both intervention days
The main questions it aims to answer are
Does a ketone drink improve information processing in patients with SSDBD
Other questions it aims to answer are
Does a ketone drink improve cognitive functioning in patients with SSDBD Does a ketone drink improve metabolism and inflammation in patients with SSDBD
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 4xday only on both intervention days
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None