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Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

R

Ricard Marcos

Status

Enrolling

Conditions

Occupational Exposure
Damage Dna
Genotoxicity

Treatments

Other: Micro and nanoplastic

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

45 participants in 3 patient groups

1. Textile industry workers
Description:
Workers from the textile industry, that manufactures non-wovens fibers
Treatment:
Other: Micro and nanoplastic
2. Plastic Recycling Workers
Description:
Workers involved in recycling and waste management of plastic
Treatment:
Other: Micro and nanoplastic
3. Controls
Description:
Control group that will match the characteristics of grup 1 and 2

Trial contacts and locations

4

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Central trial contact

Alba Hernández, Professor

Data sourced from clinicaltrials.gov

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