Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

Ricard Marcos45 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Occupational Exposure Genotoxicity Damage Dna

Interventions

Micro and nanoplasticOTHER

Biological samples will be obtained to evaluate the different biomarkers selected

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Textile industry

Helsinki, Finland

COMPLETED

Recycling company

Alicante, Spain

COMPLETED

Textile Industry

Alicante, Spain

COMPLETED

Control recruitment

Barcelona, Spain

Outcomes

Primary Outcomes

Characterization of macro and nanoplastics

The characterization of macro and nanoplastics will be done by Raman spectrosmicroscopy and FTIR (From exhaled breath condensate, blood and urine)

Time frame: Up to 1 year

Genotoxic evaluation by the Micronucleus assay

Blood and buccal cells will be collected from donors to check for the presence of genotoxic permanent damage

Time frame: Up to 1 year

Genotoxic evaluation by the Comet assay

Blood will be analysed to check for the presence of genotoxic primary damage

Time frame: Up to 1 year

Cytokine release

Plasma will be analysed to check for the presence of cytokines

Time frame: Up to 1 year

Microbiota analysis from feces by MinIOn

Feces will be analysed to check for variations in microbiota in the exposed and control groups

Time frame: up to 1 year

Secondary Outcomes

Analyses of surrogate biomarkers

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.

Time frame: Up to 1 year

Central Contacts

Alba Hernández, Professor

CONTACT

+34 93 581 4702 alba.hernandez@uab.cat

Data from ClinicalTrials.gov

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