Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546683
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Brain Responses to Short-Chain Fatty Acid Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of a Short-Chain Fatty Acid Intervention on Affective Brain Circuits and Neuroepigenetics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MoodBugs HDAC
Brief Summary:
A randomized triple-blind placebo-controlled study on the effect of colon-delivered short-chain fatty acids SCFAs on neural responses to stress and neuroepigenetics
Detailed Description:
The goal of this interventional study is to study the underlying mechanism of the attenuating effect of colon-delivered SCFAs on the cortisol response to stress Pre-clinical studies suggest that the histone-deacetylase HDAC-inhibiting properties of SCFAs are the main mechanism underlying SCFA-induced changes in stress cognition and behavior
Primary objective to test the effect of colon-delivered SCFA intervention versus placebo on HDAC expression in the brain and neural responses to stress
Secondary objective to determine the effects of colon-delivered SCFA administration versus placebo on inflammatory and autonomic responses to stress and to determine the mediating andor moderating factors that potentially underlie SCFA-induced changes to stress responses HDAC expression in stress-responsive regions serum SCFA levels
To this end 32 participants will be asked to undergo a pre- and post-intervention visit separated by one week intervention with either colon-delivered SCFAs or placebo 16 per group During the study visits participants undergo simultaneous PET-MR imaging with 11CMartinostat They undergo the Montreal Imaging Stress Test MIST and the Maastricht Acute Stress Test MAST at each visit
Primary objective to test the effect of colon-delivered SCFA intervention versus placebo on HDAC expression in the brain and neural responses to stress
Secondary objective to determine the effects of colon-delivered SCFA administration versus placebo on inflammatory and autonomic responses to stress and to determine the mediating andor moderating factors that potentially underlie SCFA-induced changes to stress responses HDAC expression in stress-responsive regions serum SCFA levels
To this end 32 participants will be asked to undergo a pre- and post-intervention visit separated by one week intervention with either colon-delivered SCFAs or placebo 16 per group During the study visits participants undergo simultaneous PET-MR imaging with 11CMartinostat They undergo the Montreal Imaging Stress Test MIST and the Maastricht Acute Stress Test MAST at each visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None