Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect

NCT ID: NCT05910489

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Microplastics Nanoplastics Genotoxic Damage Inflammation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Biomonitoring studies to detect MNPLs in biological samples and study of health effects.

Determination of MNPLs levels, genotoxic damage, and immunological effects

Biomonitoring of MNPLs in biological samples of greenhouse workers and controls

Intervention Type OTHER

Detection of biomarkers of exposure and genotoxic effect in biological blood, urine, exhalated air condensate, and feces

Greenhouse workers

Biomonitoring studies to detect MNPLs in biological samples and study of health effects.

Determination of MNPLs levels, genotoxic damage, and immunological effects

Biomonitoring of MNPLs in biological samples of greenhouse workers and controls

Intervention Type OTHER

Detection of biomarkers of exposure and genotoxic effect in biological blood, urine, exhalated air condensate, and feces

Interventions

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Biomonitoring of MNPLs in biological samples of greenhouse workers and controls

Detection of biomarkers of exposure and genotoxic effect in biological blood, urine, exhalated air condensate, and feces

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

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


* Participation in another clinical study
* Pregnancy
* Unsigned informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

OTHER

Sponsor Role collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role collaborator

Ricard Marcos

OTHER

Sponsor Role lead

Responsible Party

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Ricard Marcos

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pablo Pelegrín

Role: PRINCIPAL_INVESTIGATOR

Instituto Murciano de Investigación Biosanitaria (IMIB)

Juan Bernardo Cabezuelo

Role: STUDY_CHAIR

Hospital Clínico Universitario Virgen de Arrixaca (Murcia)

Laura Martínez

Role: STUDY_CHAIR

Hospital Clínico Universitario Virgen de Arrixaca (Murcia)

Central Contacts

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Ricard Marcos

Role: CONTACT

+34 93 586 20 52

Other Identifiers

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2-1

Identifier Type: -

Identifier Source: org_study_id

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