Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552156
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
FOod Additives on the Mucosal Barrier
Sponsor:
None
Organization:
None
Study Overview
Official Title:
FOod Additives on the Mucosal Barrier
Status:
COMPLETED
Status Verified Date:
2024-07
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:
FOAM
Brief Summary:
This is a 6-week pilot study in 60 healthy volunteers to explore 1 the effect of an emulsifier-free diet 2 the effect of three dietary emulsifiers which are believed to detrimentally affect human health 3 and the effect of two neutral alternatives native rice starch and soy lecithin compared to placebo on intestinal permeability and inflammation systemic inflammation and the gut microbiota
Detailed Description:
This is a 6-week randomized double-blind placebo-controlled pilot study in 60 healthy volunteers to explore 1 the effect of an emulsifier-free diet 2 the effect of dietary emulsifiers carrageenan CMC and Polysorbate-80 which are believed to detrimentally affect human health 3 and the effect of neutral alternatives native rice starch and soy lecithin on intestinal permeability and inflammation systemic inflammation and the gut microbiota
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