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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Microplastics; Nanoplastics; Genotoxic Damage
• Intervention / Treatment: Other: Biomonitoring of MNPLs in biological samples of greenhouse workers and controls

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.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Ricard Marcos; Phone Number: +34 93 586 20 52; Email: ricard.marcos@uab.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Biomonitoring studies to detect MNPLs in biological samples and study of health effects. Determination of MNPLs levels, genotoxic damage, and immunological effects	Other: 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
Greenhouse workers; Biomonitoring studies to detect MNPLs in biological samples and study of health effects. Determination of MNPLs levels, genotoxic damage, and immunological effects	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomonitoring study to detect the presence of MNPLs in body fluids	Blood, buccal cells, exhalate breath condensate, feaces and urine will be collected from donors to check for the presence of micro and nanoplastics and/or derivatives	Up to 1 year
Genotoxicity effects of exposure to MNPLs	Blood and buccal cells will be collected from donors to check for the presence genotoxic permanent damage, assessed by the micronucleus assay	Up to 1 year
Genotoxicity effects of exposure to MNPLs	Blood will be collected from donors to check for the presence genotoxic non-permanent damage, assessed by the comet assay	up to 1 year
Study of the effects of MNPLs on immune system	Blood will be collected from donors to check if the presence of micro and nanoplastics have an effect on th function of the immune system (signalling and activation) in vivo and in high-risk individuals	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surrogate biomarkers after MNPLs exposure	If it is possible to correlate the presence of micro and nanoplastics with the presence of plastic derivatives in body fluids, as blood or urine, this will facilitate the detection of plastic, because tecniques to detect surrogate biomarkers as e.g. plasticizers or antioxidants are cheaper and most use than the tecnology to detect MNPLs. For that different analytical tecniques will be used.	Up to 1 year

Collaborators and Investigators

• Sponsor: Ricard Marcos
• Collaborators: Hospital Universitario Virgen de la Arrixaca; Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
• Investigators: Principal Investigator: Pablo Pelegrín, Instituto Murciano de Investigación Biosanitaria (IMIB); Study Chair: Juan Bernardo Cabezuelo, Hospital Clínico Universitario Virgen de Arrixaca (Murcia); Study Chair: Laura Martínez, Hospital Clínico Universitario Virgen de Arrixaca (Murcia)

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MNPLs; greenhouse workers
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No