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

NCT05910489 | Not Yet Recruiting DMC

• 1 other identifier: 2-1
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Microplastics; Nanoplastics; Genotoxic Damage; Inflammation

Keywords

MNPLs; greenhouse workers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Surrogate biomarkers after MNPLs exposure

  Up to 1 year

Study Arms (2)

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

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

Interventions

Biomonitoring of MNPLs in biological samples of greenhouse workers and controls OTHER

Detection of biomarkers of exposure and genotoxic effect in biological blood, urine, exhalated air condensate, and feces

Control; Greenhouse workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• Participation in another clinical study
• Pregnancy
• Unsigned informed consent
• Participation in another clinical study
• Pregnancy
• Unsigned informed consent

Sponsors & Collaborators

• Ricard Marcos: lead
• Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood, urine, feces

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pablo Pelegrín

  Instituto Murciano de Investigación Biosanitaria (IMIB)

  PRINCIPAL INVESTIGATOR

• Juan Bernardo Cabezuelo

  Hospital Clínico Universitario Virgen de Arrixaca (Murcia)

  STUDY CHAIR

• Laura Martínez

  Hospital Clínico Universitario Virgen de Arrixaca (Murcia)

  STUDY CHAIR

Central Study Contacts

Ricard Marcos

CONTACT

+34 93 586 20 52; ricard.marcos@uab.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: June 18, 2023
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02