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The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health

NCT05864352 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-05-07

No results posted yet for this study

Summary

This proposal will quantify dietary exposure of a nano- food additive in the U.S. food supply, and determine its impact on the human gut microbiome, gut inflammation, permeability and oxidative stress. Titanium dioxide (TiO2, or E171 food grade additive) is used in processed foods, with thousands of tons produced annually and an expected increase \>8.9% from 2016 to 2025. Preclinical models demonstrate \>99% of consumed TiO2 is retained within the intestinal lumen and excreted in the feces. In animal models, dietary TiO2 causes shifts in the gut microbiome, decreases acetate production, increases biofilm formation, and causes profound disruption of gut homeostasis and intestinal tight junctions, due to the production of reactive oxygen species and increased inflammation. However, the relation between chronic TiO2 intake and human gut homeostasis has yet to be elucidated. France issued an executive order to ban food grade TiO2 use after January 1st 2020, over serious safety concerns. Since then, multiple European civil societies have jointly called for an executive order to ban TiO2 across the EU. Typical TiO2 intake among U.S. adults remains to be documented, and there are no known studies that estimate dietary exposure of TiO2 using a whole foods approach. Therefore, the overarching goals of this project are to: 1) measure dietary TiO2 exposure in a sample of U.S. adults, using dietary recalls and fecal TiO2 content; 2) determine how fecal TiO2 content is related to gut dysbiosis, metatranscriptomics, intestinal inflammation, permeability and oxidative stress.

Conditions

Sponsors & Collaborators

  • United States Department of Agriculture (USDA)

    collaborator FED

  • Wright Labs

    collaborator UNKNOWN

  • University of Massachusetts, Lowell

    lead OTHER

Principal Investigators

  • Kelsey M Mangano, PhD · University of Massachusetts, Lowell

Eligibility

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

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2022-11-18
Completion
2022-11-28

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT05864352 on ClinicalTrials.gov