The aim of this study is to characterize the internal 1 µm polystyrene microplastic (PS-MP) exposure in various human tissues in healthy volunteers. For this, the uptake and excretion of a single microdose of 1 µm [14C]-labelled PS-MP is…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
opname en excretie van oraal toegediende C14 gelabelde polystyreen-microplastic deeltjes
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantitative measurement of the biokinetics (i.e. absorption, distribution, and
excretion) of a single oral microdose (100 µg) of 1 µm [14C]-labelled PS-MP
Secondary outcome
Not applicable
Background summary
Micro- and nanoplastics (MNPs, plastic particles < 5 mm) are increasingly found
in food, water and air. Despite research advances in recent years, we still
need to learn more about their biokinetics in the human body. In recent years,
the Netherlands Organisation for Health Research and Development (ZonMw) funded
several *breakthrough* projects to address the most urgent knowledge gaps in
the field of MNPs and human health, which were consequently integrated in one
large research initiative called the Microplastics and Human Health consortium
(MOMENTUM). The overall aim of this project is to assess the potential human
health risks of MNPs. A main objective of the project is to perform a
provisional risk assessment of MNPs, largely based on the results of in vitro
toxicity studies. To extrapolate effects observed in in vitro models the used
MNP concentration in vitro need to be extrapolated to an external (human)
exposure. Such an extrapolation can be facilitated by so-called toxicokinetic
models. The quality of the predictions based on such model need to be
benchmarked against in vivo data. Currently no data from a human toxicokinetic
study is available. Some data that suggest the presence of MNP in human blood
or tissues are available, however for these studies the (route of) exposure is
unknown and has not been quantified. Therefore, a human MNP microdosing study
is now proposed.
Study objective
The aim of this study is to characterize the internal 1 µm polystyrene
microplastic (PS-MP) exposure in various human tissues in healthy volunteers.
For this, the uptake and excretion of a single microdose of 1 µm [14C]-labelled
PS-MP is investigated using an extremely sensitive Accelerator Mass
Spectrometry (AMS) for the analysis (as performed in METC P2309,
NL84060.028.23). By labelling 1 *m PS-MPs with 14C (a universal labelling
technique in which all 12C atoms in the molecule are replaced by 14C atoms), we
can trace the labelled PS-MPs in body samples (blood, urine and faeces).
Study design
Single centre, non-randomised, single oral administration study
Intervention
A single test day during which participants will orally ingest a single
microdose 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 burden and risks
The drawing of blood by venepuncture and cannula carries a small risk of local
hematoma. The proposed single oral dose of 100 µg PS-MP is below the threshold
of toxicological concern for less-lifetime exposure suggested by the ICH M7
guideline and considered safe for volunteers. Moreover, the admitted single
dose is in the range of the estimated daily exposure to environmental
microplastics of humans and thus the added risk is negligible. The test product
will contain a micro tracer amount of 1 µm [14C]-labelled PS-MP (not more than
(NMT 15 kBq, 405 nCi), so the volunteers will be exposed to ionising radiation.
However, the effective dose was calculated to be 0.011 mSv, which is within
risk category I of the ICRP (1992). For comparison, the present study will
provide a lower dose of radiation than the ordinary background radiation in the
Netherlands (i.e. 2.5 mSv/year), and a lower level to that which one would be
exposed to during an airflight to Indonesia (approximately 0.09 mSv).
De Elst 1
Wageningen 6708 WD
NL
De Elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
Inclusion criteria
• 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·m2
• 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)
Exclusion criteria
• 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
• 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88025.028.25 |