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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Biokinetic profile (absorption, distribution, excretion) of [14C]-labelled PS-MP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Single arm
[14C]-labelled PS-MP ingestion
干预措施: 1 μm [14C]-labelled Polystyrene Microplastic (Drug)
结局指标
主要结局
Biokinetic profile (absorption, distribution, excretion) of [14C]-labelled PS-MP
时间窗: 5 days post-administration
Quantitative assessment of 14C content in blood, urine, and feces using Accelerator Mass Spectrometry
次要结局
未报告次要终点
研究者
Marlou Dirks
Assistant Professor
Wageningen University