Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT06426134
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)
Study:
NCT06426134
Study Brief:
Protocol Section:
NCT06426134