Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

Occupational Exposure Clinical Trial

Official title:

Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323603
• Other study ID #: 3-1
• Status: Recruiting
• Start date: June 30, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Universitat Autonoma de Barcelona
• Contact: Alba Hernández, Professor
• Phone: +34 93 581 4702
• Email: alba.hernandez[@]uab.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Genotoxicity
• Occupational Exposure

Intervention

Other:
• Micro and nanoplastic
Biological samples will be obtained to evaluate the different biomarkers selected

Locations

Country	Name	City	State
Finland	Textile industry	Helsinki
Spain	Recycling company	Alicante
Spain	Textile Industry	Alicante
Spain	Control recruitment	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Ricard Marcos	Finnish Institute of Occupational Health

Countries where clinical trial is conducted

Finland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Genotoxic evaluation by the Comet assay	Blood will be analysed to check for the presence of genotoxic primary damage	Up to 1 year
Primary	Cytokine release	Plasma will be analysed to check for the presence of cytokines	Up to 1 year
Primary	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	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