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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05910489
• Other study ID #: 2-1
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Universitat Autonoma de Barcelona
• Contact: Ricard Marcos
• Phone: +34 93 586 20 52
• Email: ricard.marcos[@]uab.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ricard Marcos	Hospital Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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