Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Genotoxic evaluation by the Comet assay
研究概览
简要总结
The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics.
详细描述
The exponential increase in the production and use of plastic goods translates into a parallel increase of environmental plastic waste that is continuously degraded into micro and nanoplastics (MNPLs). Information on their effects on human health is still preliminary, especially regarding human biomonitoring studies, thus more information is required for risk assessment evaluation.
This observational study aims to evaluate the exposure to MNPLs in human populations occupationally exposed to different types of plastics (fibers and plastic waste). The study will evaluate the effect of exposure to MNPLs (genotoxic and microbiota effects) in different body samples (blood, exfoliated buccal cells, urine,and feces) and also will use those samples to evaluate the presence of MNPLs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Aged over 18 years.
- •Healthy subjects defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urine analysis.
- •Able to participate and willing to give written informed consent and to comply with the study restrictions.
- •Have been working at the company for the last 48 months
排除标准
- •Workers decline participation
- •Legal incapacity or inability to understand or comply with the requirements of the study.
- •Any hierarchical subordination to the PI
- •Clinically significant findings as determined by medical history taking, physical examination, ECG, and vital signs.
- •Submitted to X-ray in the three previous months
结局指标
主要结局
Genotoxic evaluation by the Comet assay
时间窗: Up to 1 year
Blood will be analysed to check for the presence of genotoxic primary damage
Cytokine release
时间窗: Up to 1 year
Plasma will be analysed to check for the presence of cytokines
Characterization of macro and nanoplastics
时间窗: Up to 1 year
The characterization of macro and nanoplastics will be done by Raman spectrosmicroscopy and FTIR (From exhaled breath condensate, blood and urine)
Genotoxic evaluation by the Micronucleus assay
时间窗: Up to 1 year
Blood and buccal cells will be collected from donors to check for the presence of genotoxic permanent damage
Microbiota analysis from feces by MinIOn
时间窗: up to 1 year
Feces will be analysed to check for variations in microbiota in the exposed and control groups
次要结局
- Analyses of surrogate biomarkers(Up to 1 year)
研究者
Ricard Marcos
Professor
Universitat Autonoma de Barcelona