NCT07075991

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

The Uptake and Excretion of a Single Oral Dose of 1 µm [14C]-Labelled Polystyrene Microplastic Particles in Healthy Volunteers Using a Micro Dose Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Wageningen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Human exposure to micro- and nanoplastics (MNPs) is increasingly recognized, yet their internal behavior in the body-absorption, distribution, and elimination-is still not well understood. No human data currently exist to support toxicokinetic modeling, which is essential for translating laboratory (in vitro) data into risk assessments. This study addresses this gap by quantifying the biokinetics of a single oral microdose of 1 μm \[14C\]-labelled polystyrene microplastics in healthy volunteers. By using Accelerator Mass Spectrometry (AMS), extremely low concentrations of radiolabeled particles can be accurately measured in biological matrices (blood, urine, and feces). This will provide critical benchmark data to validate in vitro-to-in vivo extrapolations and improve human health risk assessments for microplastics.

Conditions

• Kinetics

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-19
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2025-07-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Netherlands