KineticsNCT07075991
Uptake and Excretion of a Single Dose of Oral 14C-labelled Polystyrene Microplastics in Healthy Volunteers
A study testing 1 μm [14C]-labelled Polystyrene Microplastic in people with Kinetics, run by Wageningen University at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kinetics
- What is being tested?
- 1 μm [14C]-labelled Polystyrene Microplastic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jun 2025to 31 Aug 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 18.5 < 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
- Pregnant or breastfeeding
- Subjects who have taken antibiotics within the 60 days prior to the adaptation period.
- Unable to give consent
- Employed or undertaking a thesis or internship at the department of Human and Animal Physiology
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Department of Human and Animal Physiology
Wageningen, 6708 WD
About this study
Official title: 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
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?
Read more
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.
Read the 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
- Being tested
- 1 μm [14C]-labelled Polystyrene Microplastic
- Keywords
- Microplastics, Uptake, Excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 μm [14C]-labelled Polystyrene MicroplasticDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | [14C]-labelled PS-MP ingestion Receives: Drug: 1 μm [14C]-labelled Polystyrene Microplastic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biokinetic profile (absorption, distribution, excretion) of [14C]-labelled PS-MP
Quantitative assessment of 14C content in blood, urine, and feces using Accelerator Mass Spectrometry
Measured: 5 days post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start19 Jun 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, TNO
- Responsible party
- Principal investigator, Marlou Dirks, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075991
- Sponsor's protocol ID
- NL88025.028.25
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07075991
- Acronym / sponsor ID
- NL88025.028.25
- Conditions
- Kinetics
- Keywords
- Microplastics, Uptake, Excretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, TNO
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: 1 μm [14C]-labelled Polystyrene Microplastic[14C]-labelled PS-MP ingestion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 18.5 < 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 μm [14C]-labelled Polystyrene MicroplasticA 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. | Drug | Single arm |
Primary outcome
Biokinetic profile (absorption, distribution, excretion) of [14C]-labelled PS-MP
Time frame: 5 days post-administration
Quantitative assessment of 14C content in blood, urine, and feces using Accelerator Mass Spectrometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 μm [14C]-labelled Polystyrene Microplastic in people with Kinetics, run by Wageningen University at 1 site in Netherlands.
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 5 inclusion and 19 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 20 Feb 2026. 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 Netherlands. 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?
Biokinetic profile (absorption, distribution, excretion) of [14C]-labelled PS-MP (time frame: 5 days post-administration). 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 20 Feb 2026.