Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

Last updated: March 21, 2024
Sponsor: Ricard Marcos
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Micro and nanoplastic

Clinical Study ID

NCT06323603
3-1
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged over 18 years.
  • Healthy subjects defined by the absence of evidence of any active or chronic diseasefollowing a detailed medical and surgical history, a complete physical examinationincluding vital signs, 12-lead ECG, haematology, blood chemistry, and urine analysis.
  • Able to participate and willing to give written informed consent and to comply withthe study restrictions.
  • Have been working at the company for the last 48 months

Exclusion

Exclusion Criteria:

  • Workers decline participation
  • Legal incapacity or inability to understand or comply with the requirements of thestudy.
  • Any hierarchical subordination to the PI
  • Clinically significant findings as determined by medical history taking, physicalexamination, ECG, and vital signs.
  • Submitted to X-ray in the three previous months

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Micro and nanoplastic
Phase:
Study Start date:
June 30, 2023
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Textile industry

    Helsinki,
    Finland

    Completed

  • Recycling company

    Alicante,
    Spain

    Completed

  • Textile Industry

    Alicante,
    Spain

    Completed

  • Control recruitment

    Barcelona,
    Spain

    Active - Recruiting

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