NCT06552156

FOod Additives on the Mucosal Barrier

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Emulsifier	Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-06-13
• Completion: 2023-06-13
• First posted: 2024-08-13
• Last updated: 2024-08-13

Locations

1 site across 1 country: Belgium