Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic
- Conditions
- Damage DnaGenotoxicityOccupational Exposure
- Interventions
- Other: Micro and nanoplastic
- Registration Number
- NCT06323603
- Lead Sponsor
- Ricard Marcos
- Brief Summary
The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1. Textile industry workers Micro and nanoplastic Workers from the textile industry, that manufactures non-wovens fibers 2. Plastic Recycling Workers Micro and nanoplastic Workers involved in recycling and waste management of plastic
- Primary Outcome Measures
Name Time Method Genotoxic evaluation by the Comet assay Up to 1 year Blood will be analysed to check for the presence of genotoxic primary damage
Cytokine release Up to 1 year Plasma will be analysed to check for the presence of cytokines
Characterization of macro and nanoplastics 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 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 up to 1 year Feces will be analysed to check for variations in microbiota in the exposed and control groups
- Secondary Outcome Measures
Name Time Method Analyses of surrogate biomarkers Up to 1 year Different metabolites will be analysed in the urine of participants, as an indirect measure to detect plastic exposure (p.eg. ftalates).
The selection of the metabolite will depend of other analyses done on the project.
Trial Locations
- Locations (4)
Control recruitment
🇪🇸Barcelona, Spain
Textile industry
🇫🇮Helsinki, Finland
Recycling company
🇪🇸Alicante, Spain
Textile Industry
🇪🇸Alicante, Spain