Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

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

Study Overview

• Status: Recruiting
• Conditions: Occupational Exposure; Genotoxicity; Damage Dna
• Intervention / Treatment: Other: Micro and nanoplastic

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.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Alba Hernández, Professor; Phone Number: +34 93 581 4702; Email: alba.hernandez@uab.cat

Study Locations

• Finland
  • Helsinki, Finland
    • Completed
    • Textile Industry
• Spain
  • Alicante, Spain
    • Completed
    • Recycling company
  • Alicante, Spain
    • Completed
    • Textile Industry
  • Barcelona, Spain
    • Recruiting
    • Control recruitment
    • Contact: Susana Pastor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1. Textile industry workers; Workers from the textile industry, that manufactures non-wovens fibers	Other: Micro and nanoplastic; Biological samples will be obtained to evaluate the different biomarkers selected
2. Plastic Recycling Workers; Workers involved in recycling and waste management of plastic	Other: Micro and nanoplastic; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Up to 1 year
Genotoxic evaluation by the Comet assay	Blood will be analysed to check for the presence of genotoxic primary damage	Up to 1 year
Cytokine release	Plasma will be analysed to check for the presence of cytokines	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	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 year

Collaborators and Investigators

• Sponsor: Ricard Marcos
• Collaborators: Finnish Institute of Occupational Health
• Investigators: Principal Investigator: Julia Catalan, Researcher, FIOH

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Biomonitoring; Genotoxic damage; Micro and nanoplastic
• Other Study ID Numbers: 3-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No