Clinical trial NCT06323603: Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic
Official title: Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Occupational Exposure
Genotoxicity
Damage Dna
Keywords: Biomonitoring
Genotoxic damage
Micro and nanoplastic
Lead sponsor: Universitat Autonoma de Barcelona
Sponsor class: OTHER
Collaborators: name: Finnish Institute of Occupational Health
First posted: 2024-03-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to determine whether workers occupationally exposed to different plastics show increased genomic damage, changes in cytokine expression and/ or microbiota. Moreover, the levels of macro/microplastics in different body fluids will be characterized.

Different European populations dedicated to the recycling of plastics and the production of non-woven textiles will be used, as well as a control group that will match according to the characteristics of the populations.

At least 50 workers from each of the participating industries will be used to demonstrate a higher exposure MNPLs level and, therefore, an increased health risk.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterization of macro and nanoplastics
timeFrame: Up to 1 year
measure: Genotoxic evaluation by the Micronucleus assay
timeFrame: Up to 1 year
measure: Genotoxic evaluation by the Comet assay
timeFrame: Up to 1 year
measure: Cytokine release
timeFrame: Up to 1 year
measure: Microbiota analysis from feces by MinIOn
timeFrame: up to 1 year
Secondary outcomes:
measure: Analyses of surrogate biomarkers
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Textile industry
city: Alicante
country: Spain
facility: Recycling company
city: Alicante
country: Spain
facility: Textile Industry
city: Barcelona
country: Spain
facility: Control recruitment
Study officials:
affiliation: FIOH
name: Julia Catalan, Researcher
role: PRINCIPAL_INVESTIGATOR
References: