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

NCT07075991 | Completed

• 1 other identifier: NL88025.028.25
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microplastics; Uptake; Excretion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

\[14C\]-labelled PS-MP ingestion

Drug: 1 μm [14C]-labelled Polystyrene Microplastic

Interventions

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.

Single arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females using contraception during and for 3 months after the study.
• Aged from 18-65 years at the time of signing informed consent
• \< BMI \< 25 kg·m-2
• Must be willing and able to communicate and participate in the whole study
• Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

You may not qualify if:

• Diabetes (Type 1, Type 2, or genetic form of diabetes)
• Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastro-intestinal disease, immunodeficiency, endocrine, neurological or psychiatric disorders
• Known severe kidney problems
• Subjects who have regular gastrointestinal complaints including abdominal pain, stomach upsets and borborygmi, known or suspected irritable bowel syndrome, or functional constipation
• Recent or chronic history of diarrhoea
• Known anaemia
• Known impaired liver function
• A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia.
• Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
• History of any drug or alcohol abuse in the past two years
• A confirmed positive alcohol breath test at screening or admission
• Any known food allergies or intolerances to the 14 major food allergens (celery, cereals containing gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, tree nuts, peanuts, sesame seeds, soybeans, sulphur dioxide and sulphites) or history of a malabsorption syndrome including coeliac disease
• Currently taking part in other scientific research
• Having received a product with 14C in the past 12 months

Sponsors & Collaborators

• Wageningen University: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• TNO: collaborator

Study Sites (1)

Wageningen University, Department of Human and Animal Physiology

Wageningen, 6708 WD, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: June 19, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)