Clinical trial NCT05910489: Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect
Official title: New Tools for the Detection of Micro and NanoPLastics (MNPLs) in Greenhouse Workers as a Population Highly Exposed to Plastics: Effect on Different Biomarkers of Genotoxic Effect
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Microplastics
Nanoplastics
Genotoxic Damage
Inflammation
Keywords: MNPLs; greenhouse workers
Lead sponsor: Universitat Autonoma de Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
name: Hospital Universitario Virgen de la Arrixaca
First posted: 2023-06-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will study adult professionals working in greenhouses in the countryside of Cartagena and Almeria. At least 25 volunteer professionals willing to participate in the study will be evaluated.

Brief summary: MNPLs effects on human health are still preliminary. Workers exposed to plastic residues are exposed constantly to MNPLs. One of these jobs corresponds to greenhouse workers, that could be considered as a population highly exposed to plastics. The objective of the research is to be able to detect MNPLs on body fluids as well as their potential genotoxic and immunological damage.

Detailed description: The exponential increase in the production/use of plastic translates into a parallel increase of environmental plastic waste that is continuously degraded into MNPLs. Information on the MNPLs' effects on human health is still preliminary and, furthermore, the limitations in current methodologies prevent accurate exposure/risk assessment.

This observational study will obtain body samples of greenhouse workers and from a control group. That would allow optimizing specific biomarkers of human MNPLs exposure and the characterization of biomarkers of early effect that allows an association among the exposure to MNPLs and effects on human health.

Eligibility criteria: Inclusion Criteria of workers exposed to plastic residues:

* Working in an operating greenhouse for a period of 1 month or more
* Age over 18 years old
* Absence of chronic pathology including neoplasia
* Absence of infectious disease at the date of sample collection and for a period of more than 2 weeks
* Spanish residence

Inclusion Criteria of controls :

* Age over 18 years old. Matched by age, gender, and lifestyle to the exposed group.
* Absence of chronic pathology including neoplasia
* Absence of infectious disease at the date of sample collection and for a period of more than 2 weeks
* Spanish residence

Exclusion Criteria of workers exposed to plastic residues:

* Participation in another clinical study
* Pregnancy
* Unsigned informed consent

Exclusion Criteria of controls:

* Participation in another clinical study
* Pregnancy
* Unsigned informed consent

Primary outcomes:
measure: Biomonitoring study to detect the presence of MNPLs in body fluids
timeFrame: Up to 1 year
measure: Genotoxicity effects of exposure to MNPLs
timeFrame: Up to 1 year
measure: Genotoxicity effects of exposure to MNPLs
timeFrame: up to 1 year
measure: Study of the effects of MNPLs on immune system
timeFrame: Up to 1 year
Secondary outcomes:
measure: Surrogate biomarkers after MNPLs exposure
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Murciano de Investigación Biosanitaria (IMIB)
name: Pablo Pelegrín
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario Virgen de Arrixaca (Murcia)
name: Juan Bernardo Cabezuelo
role: STUDY_CHAIR
affiliation: Hospital Clínico Universitario Virgen de Arrixaca (Murcia)
name: Laura Martínez
role: STUDY_CHAIR
References: