Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

NCT06323603 | Recruiting DMC

• 1 other identifier: 3-1
• Study Type: observational
• Target: 45
• Locations: 2 countries
• Sites: 4

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.

Conditions

Occupational Exposure; Genotoxicity; Damage Dna

Keywords

Biomonitoring; Genotoxic damage; Micro and nanoplastic

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Analyses of surrogate biomarkers

  Up to 1 year

Study Arms (3)

1. Textile industry workers

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

Other: Micro and nanoplastic

2. Plastic Recycling Workers

Workers involved in recycling and waste management of plastic

Other: Micro and nanoplastic

3. Controls

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

Interventions

Micro and nanoplastic OTHER

Biological samples will be obtained to evaluate the different biomarkers selected

1. Textile industry workers; 2. Plastic Recycling Workers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ricard Marcos: lead
• Finnish Institute of Occupational Health: collaborator

Study Sites (4)

Textile industry

Helsinki, Finland

COMPLETED

Recycling company

Alicante, Spain

COMPLETED

Textile Industry

Alicante, Spain

COMPLETED

Control recruitment

Barcelona, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, exhaled breath condensate, exfoliated buccal cells, urine and feces

Study Officials

• Julia Catalan, Researcher

  FIOH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alba Hernández, Professor

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: June 30, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

FI (1); ES (3)