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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06323603
Other study ID # 3-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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