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

Study Overview
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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.

Official Title
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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

Conditions
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Microplastics, Nanoplastics, Genotoxic Damage, Inflammation

Intervention / Treatment
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* Other: Biomonitoring of MNPLs in biological samples of greenhouse workers and controls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>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<br>* Detection of biomarkers of exposure and genotoxic effect in biological blood, urine, exhalated air condensate, and feces<br>|
| Greenhouse workers<br>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<br>* Detection of biomarkers of exposure and genotoxic effect in biological blood, urine, exhalated air condensate, and feces<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MNPLs; greenhouse workers