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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| TNO | OTHER |
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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:
Participants will:
This study does not include a comparison group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | [14C]-labelled PS-MP ingestion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 μm [14C]-labelled Polystyrene Microplastic | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biokinetic profile (absorption, distribution, excretion) of [14C]-labelled PS-MP | Quantitative assessment of 14C content in blood, urine, and feces using Accelerator Mass Spectrometry | 5 days post-administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University, Department of Human and Animal Physiology | Wageningen | 6708 WD | Netherlands |
IPD will be shared upon reasonable request to the Principal Investigator
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