The uptake and excretion of a single oral dose of 1 µm [14C]-labelled polystyrene microplastic particles in healthy volunteers using a microdose approach

Project description

This study involves the oral ingestion of a tiny amount of 14C labelled microplastics in healthy volunteers. By tracking this small, safe dose of labelled microplastics, researchers will generate real human data to improve laboratory (in vitro) models. These improved models will help scientists better assess the potential health risks of environmental microplastic exposure.

Who are we looking for?

• Healthy men and women aged 18–65 with normal weight. We are looking for 3 men and 3 women.
• The study will be conducted between mid-June and the end of July 2025. We will do our best to accommodate your schedule.

What's in it for you?

• All participants will receive €400 for completing the study, as well as a travel costs reimbursement.

Who can participate?

You are eligible to participate in this study if you meet the following criteria:

• You are a healthy man or woman and will use contraception for a period of 3 months starting from the beginning of the study
• You are between 18 and 65 years old at the time of signing the informed consent form
• Your BMI is between 18.5 and 25 kg/m²
• You are willing and able to participate in the entire study, including consumption of the microplastics and the meals provided during the study
• You have regular bowel movements (i.e., an average of 1 to 3 bowel movements per day)
• You typically eat three meals per day (i.e., breakfast, lunch, and dinner)
• You are deemed fit to participate based on the results of the medical screening conducted prior to the study.

You are not eligible to participate in the study if any of the following criteria apply to you:

• 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

What does the study involve?

You will visit the university a total of 6 times. The visits include:

• Consent visit
• The ingestion of a single, very small oral dose of a labelled microplastic followed by;
• A 24-hour stay in our facility in the human and animal physiology department , followed by;
• Four short daily visits (5-day total period).
• Routine collection of blood, urine, and stool samples

Is it safe?

Yes. The dose is extremely small. A small discomfort may come from standard blood draws.