opname en excretie van oraal toegediende C14 gelabelde polystyreen-microplastic deeltjes Uptake and excretion of polystyrene-macroplastic particles
Conditions
Interventions
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
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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 =1 and
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed