Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566157
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
PROMOTE The Effect of a Six Week Probiotic or Prebiotic Supplementation on Wellbeing of Young Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PROMOTE The Effect of Probiotic or Prebiotic Supplementation on Salivary Cortisol Awakening Response in Young Adults With Mild-To-Moderate Self-Reported Stress A 3-Arm Double Blinded Parallel Randomised Control Trial
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:
PROMOTE
Brief Summary:
The study will investigate whether taking either a probiotic or prebiotic for six weeks helps to reduce morning cortisol levels in healthy young adults with mild to moderate stress compared to a placebo Individuals should continue with their usual lifestyle during the study Other factors of wellbeing will also be assessed
Detailed Description:
PROMOTE is a 3-arm double blinded parallel randomised control trial investigating if either prebiotic or probiotic supplementation reduce awakening salivary cortisol response reported as area under the curve compared to a maltodextrin placebo in healthy young adults with a mild-to-moderate self reported stress score There will be a focus on biological secondary outcomes to better understand how supplementation may influence the microbiome using metabolomics and sequencing techniques In addition to other measures of wellbeing captured by questionnaires and activity monitors
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