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Uptake and Excretion of a Single Dose of Oral 14C-labelled Polystyrene Microplastics in Healthy Volunteers

NCT07075991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-02-20

No results posted yet for this study

Summary

The goal of this clinical trial is to understand how a small, labeled dose of microplastics moves through the human body (i.e., how it is absorbed, distributed, and excreted) in healthy adult volunteers aged 18-65 years (3 males, 3 females). The main questions it aims to answer are:

* How much of the ingested microplastic is absorbed into the bloodstream?
* How is the microplastic distributed and eliminated from the body through urine and feces?

Participants will:

* Take a single oral micro dose of 100 µg of 1 μm \[14C\]-labelled polystyrene microplastics (PS-MP).
* Spend 24 hours in a clinical research facility for close monitoring and initial sample collection.
* Provide blood, urine, and stool samples over a 5-day period (with daily short lab visits after the first day).

This study does not include a comparison group.

Conditions

  • Kinetics

Interventions

DRUG

1 μm [14C]-labelled Polystyrene Microplastic

A single test day during which participants will orally ingest a single micro dose of 100 μg 1 µm \[14C\]-labelled PS-MP. Prior to and following ingestion of the labelled PS-MP, biological samples (i.e. blood, urine, faeces) will be collected at regular intervals, throughout the 5-day study period. Participants will spend the first 24h in the clinical laboratory, after which they are allowed to spend the remainder of the 5-day study period at home but with daily visits to the laboratory for blood sampling and home collection of urine and faeces.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • TNO

    collaborator OTHER

  • Wageningen University

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Netherlands

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 NCT07075991 on ClinicalTrials.gov