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Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06323603
Enrollment
45
Registered
2024-03-21
Start date
2023-06-30
Completion date
2024-09-30
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Damage Dna, Genotoxicity, Occupational Exposure

Keywords

Biomonitoring, Genotoxic damage, Micro and nanoplastic

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.

Interventions

OTHERMicro and nanoplastic

Biological samples will be obtained to evaluate the different biomarkers selected

Sponsors

Finnish Institute of Occupational Health
CollaboratorOTHER
Ricard Marcos
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Characterization of macro and nanoplasticsUp to 1 yearThe characterization of macro and nanoplastics will be done by Raman spectrosmicroscopy and FTIR (From exhaled breath condensate, blood and urine)
Genotoxic evaluation by the Micronucleus assayUp to 1 yearBlood and buccal cells will be collected from donors to check for the presence of genotoxic permanent damage
Genotoxic evaluation by the Comet assayUp to 1 yearBlood will be analysed to check for the presence of genotoxic primary damage
Cytokine releaseUp to 1 yearPlasma will be analysed to check for the presence of cytokines
Microbiota analysis from feces by MinIOnup to 1 yearFeces will be analysed to check for variations in microbiota in the exposed and control groups

Secondary

MeasureTime frameDescription
Analyses of surrogate biomarkersUp to 1 yearDifferent 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.

Countries

Finland, Spain

Contacts

Primary ContactAlba Hernández, Professor
alba.hernandez@uab.cat+34 93 581 4702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026