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FOod Additives on the Mucosal Barrier

NCT06552156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-13

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Dietary Emulsifier

Intervention was delivered by supplying dietary emulsifiers or placebo through 3 brownies a day that participants had to consume.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • João Sabino, MD · Leuven University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-06-13
Completion
2023-06-13

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552156 on ClinicalTrials.gov