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

Not yet recruiting

• Conditions: Genotoxic Damage; Nanoplastics; Inflammation; Microplastics
• Interventions: Other: Biomonitoring of MNPLs in biological samples of greenhouse workers and controls

• Registration Number: NCT05910489
• Lead Sponsor: Ricard Marcos

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.

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Study Start: 2024-09
• Primary Completion: 2025-01
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Greenhouse workers	Biomonitoring of MNPLs in biological samples of greenhouse workers and controls	Biomonitoring studies to detect MNPLs in biological samples and study of health effects. Determination of MNPLs levels, genotoxic damage, and immunological effects
Control	Biomonitoring of MNPLs in biological samples of greenhouse workers and controls	Biomonitoring studies to detect MNPLs in biological samples and study of health effects. Determination of MNPLs levels, genotoxic damage, and immunological effects

Primary Outcome Measures

Name	Time	Method
Genotoxicity effects of exposure to MNPLs	up to 1 year	Blood will be collected from donors to check for the presence genotoxic non-permanent damage, assessed by the comet assay
Biomonitoring study to detect the presence of MNPLs in body fluids	Up to 1 year	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
Study of the effects of MNPLs on immune system	Up to 1 year	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

Secondary Outcome Measures

Name	Time	Method
Surrogate biomarkers after MNPLs exposure	Up to 1 year	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.