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InflammationNCT05864352

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

An observational study of Inflammation and Microbiota, run by University of Massachusetts, Lowell at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
How many people
80 participants
Where
1 siteUnited States
Study dates
22 Sep 2021to 28 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Participants will be recruited from the greater Lowell area, Massachusetts.

Who may be able to join

  • Healthy persons between the ages of 18 to 30 y.

Who cannot join

  • <18 years and >30 years
  • antibiotic use in the past 6 months
  • laxative use in the past 30 days
  • self-reported fever, cancer, or gastrointestinal disease (e.g., inflammatory bowel diseases, C. difficile infection
  • use of selective serotonin reuptake inhibitors (SSRI's)
  • use of non-steroidal anti-inflammatory drugs (NSAIDs) within 10 days
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  • daily use of proton pump inhibitors
  • history of gastrointestinal alteration (e.g., appendectomy, gastric bypass surgery)
  • pregnancy.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Massachusetts

    Lowell, Massachusetts, 01854

Other trials in United States

About this study

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.

Read the detailed description

The U.S. food supply contains large amounts of the food additive titanium dioxide (TiO2), but its impact on human health is unknown. The widespread use of food-grade TiO2 (E171) includes commonly consumed products, such as sweets, gums, white salad dressings, dairy creamers, pharmaceutical fillers, and toothpaste. Production of TiO2 in the U.S. is expected to increase more than 8.9% from 2016 to 2025. There are major limitations with current estimations of dietary TiO2 intake in humans. Such limitations include assessing TiO2 content solely from white-colored foods and including only foods with TiO¬2 labeled as such on its packaging. Natural food products, however, may also contribute a substantial amount of TiO¬2 to the diet. There is also a large variation in the estimated ingestion of TiO2 between studies which is likely due to differences in populations and varying food supplies, variability in analytical method used for measuring TiO2, and absence of validated dietary estimation tools to measure oral TiO2 exposure. Therefore, estimation of TiO¬2 dietary intake and gut exposure is needed among a free-living U.S. population of adults with a wide variation of intakes.

Pre-clinical models show that greater TiO2 oral exposure may lead to impaired gut health through changes in gut bacterial content and function. TiO2 has been shown to damage intestinal cells where small doses of TiO2 caused changes in normal activity, but not damage to the cell's genetics. After very small particles of TiO2 are taken up by these intestinal cells, it causes mild toxicity and disruption of the cell's function. In addition, very small particles of TiO2 accumulate in intestinal cells and remodel the cell's community in the small intestine, suggesting these particles may get absorbed into the body's blood and general circulation. These results demonstrate that very small particles of TiO2 causes harmful changes to the intestinal cells, is absorbed by the intestinal cells, and once inside, can cause harmfulness and promote abnormal cellular function. There is an urgent need for studies in humans to determine whether high versus low level exposure to TiO¬2 is related to gut inflammation and disruption in gut function.

The current study will fill these research gaps by testing the hypothesis that long term dietary exposure of TiO2 is related to gut inflammation and disturbs gut bacteria in humans. This hypothesis will be tested for the first time via these specific aims: 1) to quantify dietary TiO2 exposure by estimating dietary intake and measuring the fecal output of TiO2 in 80 adults; 2) to establish the relationship of dietary TiO2 with gut bacteria and their activity; and 3) to determine whether dietary TiO2 exposure is related to gut inflammation and associated inflammatory pathways.

Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05864352
Study groupRoleWhat they receive
High TiO2 ConsumerParticipants with an estimated TiO2 stool content greater than the cohort median content, μg/mg dry stool.
Low TiO2 ConsumerParticipants with an estimated TiO2 stool content less than the cohort median content, μg/mg dry stool.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut microbiota taxonomy and expressed pathways

    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.

    Measured: During the study week, three consecutive day period.

Secondary outcomes (3)
  1. Concentration of Intestinal Inflammation Biomarkers in Feces

    To evaluate intestinal inflammation, the concentrations of fecal calprotectin, lactoferrin, and myeloperoxidase will be measured in stool using Immundiagnostik ELISA kits.

    Measured: During the study week, three consecutive day period.

  2. Concentration of Intestinal Homeostasis and Permeability Biomarkers in Feces

    To evaluate intestinal homeostasis and permeability, the concentrations of fecal α-1-antitrypsin (AAT) and zonulin will be measured in stool using Immundiagnostik ELISA kits.

    Measured: During the study week, three consecutive day period.

  3. Concentration of Intestinal Oxidative Stress Biomarkers in Feces

    To evaluate intestinal oxidative stress, the concentrations of leukotriene D4 (LD4) and 3-nitrotyrosine (3-NT) will be measured by liquid chromatography electron spray ionization tandem mass spectrometry (LC-ESIMS/MS).

    Measured: During the study week, three consecutive day period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start22 Sep 2021
  3. Primary completion18 Nov 2022
  4. Study completion28 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05864352
Sponsor's protocol ID
21-122-MAN-XPD
Status last verified
May 2024
First submitted
8 May 2023
Last updated
7 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Deidentified data to be released to other researchers upon request to the PI.

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammation and Microbiota, run by University of Massachusetts, Lowell at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut microbiota taxonomy and expressed pathways (time frame: During the study week, three consecutive day period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.

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