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

Sponsor
Ricard Marcos (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05910489
Collaborator
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca (Other), Hospital Universitario Virgen de la Arrixaca (Other)
25
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
25 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Biomonitoring study to detect the presence of MNPLs in body fluids [Up to 1 year]

    Micro and nanoplastics and/or derivatives would be evaluated

  2. Genotoxicity effects of exposure to MNPLs [Up to 1 year]

    Micronucleus assay

  3. Genotoxicity effects of exposure to MNPLs [up to 1 year]

    Comet assay

  4. Study of the effects of MNPLs on immune system [Up to 1 year]

    Investigating the effect of MNPLs on the function of the immune system (signalling and activation) in vivo and in high-risk individuals

Secondary Outcome Measures

  1. Surrogate biomarkers after MNPLs exposure [Up to 1 year]

    Plastic derivatives in body fluids

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ricard Marcos
  • Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
  • Hospital Universitario 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ricard Marcos, Professor, Universitat Autonoma de Barcelona
ClinicalTrials.gov Identifier:
NCT05910489
Other Study ID Numbers:
  • 2-1
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ricard Marcos, Professor, Universitat Autonoma de Barcelona
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023