Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286943
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-02-16
Brief Title:
The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
The Effects of Gut Bacterial Metabolites Short-Chain Fatty Acids on Stress-Induced Impairment in Core Executive Functions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
GUTSIE
Brief Summary:
The aim of the present trial is to examine core executive functions EFs as a functional outcome of attenuating the cortisol response to acute laboratory stress through colonic delivery of an Short Chain Fatty Acids SCFAs mix acetate propionate butyrate
A triple-blind randomized placebo-controlled parallel group trial will be conducted to compare the effects of SCFAs vs placebo on core EFs working memory WM cognitive flexibility CF response inhibition RI under stress vs no-stress conditions after one week of SCFA vs placebo treatment
First the effects of SCFAs on stress-induced changes in core executive functions with WM as the primary outcome and CF and RI as secondary outcomes will be tested Second interindividual differences in microbiota composition particularly abundance of SCFA-producers saliva cortisol and serum SCFA levels will be explored to assess whether they are associated with interindividual differences in core EFs at baseline or following acute stress
Each participant will undergo 2 study visits one will involve a stress condition and the other will involve a no-stress condition Each study visit is preceded by a 1-week intervention or placebo period and separated by a 3-4 week washout period To induce stress participants will perform the Maastricht Acute Stress Task MAST or sham MAST as the control condition To assess EF performance three cognitive tasks will be performed 15 minutes after task offset n-back task for WM Stop Signal Task for RI and Wisconsin Card Sorting Test for CF Saliva samples will be collected before during and after the sham MAST to assess the cortisol response Blood samples will be collected throughout all study visits to quantify serum SCFAs inflammatory markers and ACTH Additionally cardiovascular variables will be measured and self-report questionnaires will be completed to evaluate autonomic response to the condition and subjective stress responses respectively
A triple-blind randomized placebo-controlled parallel group trial will be conducted to compare the effects of SCFAs vs placebo on core EFs working memory WM cognitive flexibility CF response inhibition RI under stress vs no-stress conditions after one week of SCFA vs placebo treatment
First the effects of SCFAs on stress-induced changes in core executive functions with WM as the primary outcome and CF and RI as secondary outcomes will be tested Second interindividual differences in microbiota composition particularly abundance of SCFA-producers saliva cortisol and serum SCFA levels will be explored to assess whether they are associated with interindividual differences in core EFs at baseline or following acute stress
Each participant will undergo 2 study visits one will involve a stress condition and the other will involve a no-stress condition Each study visit is preceded by a 1-week intervention or placebo period and separated by a 3-4 week washout period To induce stress participants will perform the Maastricht Acute Stress Task MAST or sham MAST as the control condition To assess EF performance three cognitive tasks will be performed 15 minutes after task offset n-back task for WM Stop Signal Task for RI and Wisconsin Card Sorting Test for CF Saliva samples will be collected before during and after the sham MAST to assess the cortisol response Blood samples will be collected throughout all study visits to quantify serum SCFAs inflammatory markers and ACTH Additionally cardiovascular variables will be measured and self-report questionnaires will be completed to evaluate autonomic response to the condition and subjective stress responses respectively
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