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NCT05864352 · ClinicalTrials.gov registry record
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
A clinical trial, sponsored by University of Massachusetts, Lowell.
- Completed
- Registry status
- 80
- Enrollment target
NCT05864352: Completed study, sponsored by University of Massachusetts, Lowell.
NCT05864352 is a clinical trial that has completed, run by University of Massachusetts, Lowell. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05864352 has completed, sponsored by University of Massachusetts, Lowell.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
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.
Primary Outcome
To evaluate the phylogeny and taxonomy of the gut microbiota in each of the three fecal samples per participant, fecal DNA and RNA will be isolated and purified and subject to Illumina-tag PCT to amplify 16S rRNA genes. Samples will be subject to metatranscriptomics sequencing to compare microbial community level expression signatures associated with fecal TiO2.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2022-11-28 |
What the finished NCT05864352 record still lists
NCT05864352 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05864352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05864352 about?
NCT05864352 is a clinical study titled "The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health". 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...
What is the current status of trial NCT05864352?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2021-09-22. Estimated completion is 2022-11-28.
Who is sponsoring clinical trial NCT05864352?
This trial is sponsored by University of Massachusetts, Lowell, which has 9 total clinical trials registered on ClinicalTrials.gov.
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