Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Occupational Exposure Genotoxicity Damage Dna

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1. Textile industry workers

Workers from the textile industry, that manufactures non-wovens fibers

Micro and nanoplastic

Intervention Type OTHER

Biological samples will be obtained to evaluate the different biomarkers selected

2. Plastic Recycling Workers

Workers involved in recycling and waste management of plastic

Micro and nanoplastic

Intervention Type OTHER

Biological samples will be obtained to evaluate the different biomarkers selected

3. Controls

Control group that will match the characteristics of grup 1 and 2

No interventions assigned to this group

Interventions

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Micro and nanoplastic

Biological samples will be obtained to evaluate the different biomarkers selected

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes