Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722549
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2021-01-21
Brief Title:
Effects of Butyrate on Affective Processes
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Effects of Butyrate on Affective Processes
Status:
COMPLETED
Status Verified Date:
2023-01
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:
None
Brief Summary:
The effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers
Detailed Description:
The study is an interventional triple-blind placebo-controlled parallel group design with 2 arms placebo butyrate Healthy male participants adhere to a low-fiber diet for the duration of the study 11 days At the baseline study visit measurements are taken in the lab including biological samples and psychophysiological measurements Participants then consume placebo or butyrate for 1 week and revisit the lab on day 11 for a second measurement of the outcomes of interest Specifically we investigate the effect of colonic butyrate administration on affective processing including stress sensitivity and fear-related processes eg extinction learning Volunteers also respond to questionnaires in relation to mood and GI symptoms and provide biological samples saliva blood and faecal samples for analysis of cortisol levels circulating short chain fatty acids and serum BDNF and faecal SCFA respectively
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