MicroplasticsNCT05910489
Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect
An observational study of Microplastics and Nanoplastics, run by Ricard Marcos.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microplastics, Nanoplastics, Genotoxic Damage
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Apr 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- Participation in another clinical study
- Pregnancy
- Unsigned informed consent
- Participation in another clinical study
- Pregnancy
- Unsigned informed consent
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Microplastics, Nanoplastics, Genotoxic Damage, Inflammation
- Being tested
- Biomonitoring of MNPLs in biological samples of greenhouse workers and controls
- Keywords
- MNPLs; greenhouse workers
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomonitoring of MNPLs in biological samples of greenhouse workers and controlsOther
Detection of biomarkers of exposure and genotoxic effect in biological blood, urine, exhalated air condensate, and feces
| Study group | Role | What they receive |
|---|---|---|
| Control | Biomonitoring studies to detect MNPLs in biological samples and study of health effects.
Determination of MNPLs levels, genotoxic damage, and immunological effects Receives: 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 Receives: Other: Biomonitoring of MNPLs in biological samples of greenhouse workers and controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 1 year
Secondary outcomes (1)
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study startSep 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroplasticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ricard Marcos
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca, Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Sponsor-investigator, Ricard Marcos, Universitat Autonoma de Barcelona
- Investigators
- Pablo Pelegrín, Principal investigator, Instituto Murciano de Investigación Biosanitaria (IMIB)Juan Bernardo Cabezuelo, Study chair, Hospital Clínico Universitario Virgen de Arrixaca (Murcia)Laura Martínez, Study chair, Hospital Clínico Universitario Virgen de Arrixaca (Murcia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910489
- Sponsor's protocol ID
- 2-1
- Status last verified
- Feb 2024
- First submitted
- 30 Nov 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05910489
- Acronym / sponsor ID
- 2-1
- Conditions
- Microplastics, Nanoplastics, Genotoxic Damage, Inflammation
- Keywords
- MNPLs; greenhouse workers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ricard MarcosUniversity, hospital or other
- Collaborators
- Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca, Hospital Universitario Virgen de la Arrixaca
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Biomonitoring of MNPLs in biological samples of greenhouse workers and controlsBiomonitoring studies to detect MNPLs in biological samples and study of health effects. Determination of MNPLs levels, genotoxic damage, and immunological effects |
| Greenhouse workers | – | Other: Biomonitoring of MNPLs in biological samples of greenhouse workers and controlsBiomonitoring studies to detect MNPLs in biological samples and study of health effects. Determination of MNPLs levels, genotoxic damage, and immunological effects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- Participation in another clinical study
- Pregnancy
- Unsigned informed consent
- Participation in another clinical study
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomonitoring of MNPLs in biological samples of greenhouse workers and controlsDetection of biomarkers of exposure and genotoxic effect in biological blood, urine, exhalated air condensate, and feces | Other | Control, Greenhouse workers |
Primary outcome
Biomonitoring study to detect the presence of MNPLs in body fluids
Time frame: 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
Genotoxicity effects of exposure to MNPLs
Time frame: Up to 1 year
Blood and buccal cells will be collected from donors to check for the presence genotoxic permanent damage, assessed by the micronucleus assay
Genotoxicity effects of exposure to MNPLs
Time frame: up to 1 year
Blood will be collected from donors to check for the presence genotoxic non-permanent damage, assessed by the comet assay
Study of the effects of MNPLs on immune system
Time frame: 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
1 secondary outcome
Surrogate biomarkers after MNPLs exposure
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Pelegrín principal investigator
Instituto Murciano de Investigación Biosanitaria (IMIB)
Juan Bernardo Cabezuelo study chair
Hospital Clínico Universitario Virgen de Arrixaca (Murcia)
Laura Martínez study chair
Hospital Clínico Universitario Virgen de Arrixaca (Murcia)
Questions about this trial
What is this clinical trial studying?
An observational study of Microplastics and Nanoplastics, run by Ricard Marcos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricard Marcos (+34 93 586 20 52, ricard.marcos@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomonitoring study to detect the presence of MNPLs in body fluids (time frame: Up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.