Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 1:25 PM
Study NCT ID:
NCT06552156
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FOod Additives on the Mucosal Barrier
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
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:
False
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:
False
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?: