Healthy Adult ParticipantsIDEANCT07817836
Urban Exposome and Biological Age
An observational study of Healthy Adult Participants, run by University of Pavia at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the impact of the urban exposome, including air pollution and lifestyle-related stressors, on biological aging, inflammatory pathways, oxidative stress, and DNA methylation patterns in healthy workers exposed to urban air pollution in the city of Pavia, Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Adult Participants
- How many people
- 151 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2024to 17 Nov 2025
- 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
- Adult, Older adult
Study population: The study population consists of adult workers recruited in the city of Pavia, Italy, through ICS Maugeri IRCCS and collaborating occupational settings. 151 participants are enrolled, including workers predominantly employed outdoors in urban environments with regular exposure to traffic-related air pollution, such as municipal police officers, taxi drivers, and dustmen. A comparison group will include indoor office workers with minimal occupational exposure to outdoor urban pollution, recruited through occupational health surveillance programs at ICS Maugeri and affiliated institutions, including administrative personnel from the University of Pavia. The study focuses on evaluating the relationship between urban environmental exposure, lifestyle factors, biological aging, inflammation, oxidative stress, and epigenetic modifications.
Who may be able to join
- Adults aged 18 years or older;
- Male or female participants;
- Ability and willingness to provide written informed consent;
- Employment in occupations performed predominantly outdoors in an urban environment with exposure to atmospheric pollution, i.e. employment as urban police officers, police personnel, public transport workers, taxi drivers, newsstand workers, or other outdoor urban workers in the city of Pavia;
- Employment in predominantly indoor office-based occupations with minimal occupational exposure to outdoor urban air pollution (control group), i.e. workers undergoing occupational health surveillance at ICS Maugeri or affiliated institutions.
Who cannot join
- Current diagnosis of active oncological disease;
- Current treatment with immunosuppressive therapy;
- Inability or unwillingness to provide informed consent;
- Medical conditions preventing participation in blood sampling or study assessments;
- Pregnancy or breastfeeding (if applicable and according to Ethics Committee recommendations).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impatto Dell'Ambiente Urbano Sull'età Biologica: Effetto Della qualità Dell'Aria e Dello Stress Lavorativo a Pavia su Citochine Infiammatorie e Profilo di Metilazione Del DNA
The goal of this observational study is to evaluate the impact of the urban exposome, including air pollution and lifestyle-related stressors, on biological aging, inflammatory pathways, oxidative stress, and DNA methylation patterns in healthy workers exposed to urban air pollution in the city of Pavia, Italy.
The study population included 151 adult workers, divided into two groups: outdoor workers (including police officers, taxi drivers, and dustmen) and an indoor control group composed of office workers from the University of Pavia and ICS Maugeri hospital with minimal outdoor exposure.
Read more
The main questions it aims to answer are:
- Does chronic exposure to urban air pollutants such as NO2, SO2, O3, benzene, volatile organic compounds, and PM2.5 influence inflammatory cytokines, oxidative stress markers, and biological aging?
- Is exposure to urban pollution associated with changes in DNA methylation patterns and epigenetic age acceleration?
- How do lifestyle factors, nutritional status, sleep quality, physical activity, smoking habits, and perceived quality of life interact with the urban exposome and biological outcomes?
Researchers will compare outdoor workers with indoor workers to evaluate differences in environmental exposure, inflammatory biomarkers, oxidative stress, DNA methylation profiles, and estimated biological age.
Participants will:
- Undergo clinical assessments, with interviews regarding occupational history.
- Undergo anthropometric and nutritional evaluations, including body composition analysis and blood chemistry tests; answer questionnaires about physical activity, smoking habits, sleep quality, and perceived quality of life; undergo interviews about dietary habits.
- Wear passive personal air samplers for approximately 5 working days to measure exposure to urban air pollutants.
- Provide blood samples for analysis of inflammatory cytokines, oxidative stress markers, thyroid-related biomarkers, and epigenetic modifications.
- Undergo DNA methylation analyses using epigenetic techniques to estimate biological age and evaluate associations between pollutant exposure and epigenetic changes.
- Receive feedback regarding their environmental exposure and general health and nutritional status.
This interdisciplinary observational study adopts an exposome-based approach integrating environmental monitoring, occupational medicine, nutrition, and epigenetics to better understand the relationship between urban environmental exposure and human health.
- Conditions
- Healthy Adult Participants
- Keywords
- Exposome, Life Style, Nutritional Status, Aging, Oxidative Stress, Cytokines, Tobacco Smoking, Sleep Quality, Quality of Life, Air Pollution, Epigenomics
- Medical subject headings
- Tobacco Smoking, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Outdoor exposed workers | The group consists of outdoor workers, specifically traffic police, taxi drivers and dustmen working in Pavia city area (Italy). The group is highly exposed to urban air pollutants, therefore these urban workers are particularly vulnerable to biological effects such as genetic and hormonal alterations, oxidative stress, and inflammation, which could predispone to chronic non-communicable diseases. The exposome variables are compared between the Outdoor exposed workers group and the Indoor non-exposed workers group, to identify differences among the group considering biological clock, inflammatory status and oxidative stress as the main outcome. | |
| Indoor non exposed workers | The group consists of indoor workers, specifically administrative staff of Maugeri Clinic and office workers from the University of Pavia. They are minimally exposed to urban pollutants, therefore represent the "control" group of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Methylation Profile Associated With Urban Air Pollution Exposure
DNA methylation patterns are evaluated in peripheral blood samples from participants exposed to different levels of urban air pollution. Genomic DNA is extracted and analyzed using bisulfite sequencing, quantitative polymerase chain reaction (qPCR), and pyrosequencing techniques to quantify DNA methylation in specific genomic regions. Methylation measures are evaluated in relation to participants' measured exposure to urban air pollutants.
Measured: Baseline
Secondary outcomes (1)
Biological Age Estimated using an Epigenetic Clock Analysis in Workers Exposed to Urban Air Pollution
Biological age is estimated using an epigenetic clock algorithm based on DNA methylation patterns measured in peripheral blood samples. Biological age estimates are compared between workers highly exposed to urban air pollution during outdoor occupational activities and workers with minimal occupational exposure to outdoor urban air pollution.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start21 Nov 2024
- Primary completion30 Oct 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Sponsor
- Investigators
- Stefano M Candura, MD, Prof., Principal investigator, Occupational medicine Unit, ICS Maugeri IRCCS, Pavia, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817836
- Sponsor's protocol ID
- 41379/24, date 07/26/24
- Other IDs
- B83C22002930006
- Acronym
- IDEA
- Status last verified
- May 2026
- First submitted
- 24 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impatto Dell'Ambiente Urbano Sull'età Biologica: Effetto Della qualità Dell'Aria e Dello Stress Lavorativo a Pavia su Citochine Infiammatorie e Profilo di Metilazione Del DNA
- ClinicalTrials.gov ID
- NCT07817836
- Acronym / sponsor ID
- IDEA / 41379/24, date 07/26/24
- Conditions
- Healthy Adult Participants
- Keywords
- Exposome, Life Style, Nutritional Status, Aging, Oxidative Stress, Cytokines, Tobacco Smoking, Sleep Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 14 Sep 2026 (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.
The goal of this observational study is to evaluate the impact of the urban exposome, including air pollution and lifestyle-related stressors, on biological aging, inflammatory pathways, oxidative stress, and DNA methylation patterns in healthy workers exposed to urban air pollution in the city of Pavia, Italy.
The study population included 151 adult workers, divided into two groups: outdoor workers (including police officers, taxi drivers, and dustmen) and an indoor control group composed of office workers from the University of Pavia and ICS Maugeri hospital with minimal outdoor exposure.
The main questions it aims to answer are:
- Does chronic exposure to urban air pollutants such as NO2, SO2, O3, benzene, volatile organic compounds, and PM2.5 influence inflammatory cytokines, oxidative stress markers, and biological aging?
- Is exposure to urban pollution associated with changes in DNA methylation patterns and epigenetic age acceleration?
- How do lifestyle factors, nutritional status, sleep quality, physical activity, smoking habits, and perceived quality of life interact with the urban exposome and biological outcomes?
Researchers will compare outdoor workers with indoor workers to evaluate differences in environmental exposure, inflammatory biomarkers, oxidative stress, DNA methylation profiles, and estimated biological age.
Participants will:
- Undergo clinical assessments, with interviews regarding occupational history.
- Undergo anthropometric and nutritional evaluations, including body composition analysis and blood chemistry tests; answer questionnaires about physical activity, smoking habits, sleep quality, and perceived quality of life; undergo interviews about dietary habits.
- Wear passive personal air samplers for approximately 5 working days to measure exposure to urban air pollutants.
- Provide blood samples for analysis of inflammatory cytokines, oxidative stress markers, thyroid-related biomarkers, and epigenetic modifications.
- Undergo DNA methylation analyses using epigenetic techniques to estimate biological age and evaluate associations between pollutant exposure and epigenetic changes.
- Receive feedback regarding their environmental exposure and general health and nutritional status.
This interdisciplinary observational study adopts an exposome-based approach integrating environmental monitoring, occupational medicine, nutrition, and epigenetics to better understand the relationship between urban environmental exposure and human health.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outdoor exposed workers | – | –The group consists of outdoor workers, specifically traffic police, taxi drivers and dustmen working in Pavia city area (Italy). The group is highly exposed to urban air pollutants, therefore these urban workers are particularly vulnerable to biological effects such as genetic and hormonal alterations, oxidative stress, and inflammation, which could predispone to chronic non-communicable diseases. The exposome variables are compared between the Outdoor exposed workers group and the Indoor non-exposed workers group, to identify differences among the group considering biological clock, inflammatory status and oxidative stress as the main outcome. |
| Indoor non exposed workers | – | –The group consists of indoor workers, specifically administrative staff of Maugeri Clinic and office workers from the University of Pavia. They are minimally exposed to urban pollutants, therefore represent the "control" group of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult workers recruited in the city of Pavia, Italy, through ICS Maugeri IRCCS and collaborating occupational settings. 151 participants are enrolled, including workers predominantly employed outdoors in urban environments with regular exposure to traffic-related air pollution, such as municipal police officers, taxi drivers, and dustmen. A comparison group will include indoor office workers with minimal occupational exposure to outdoor urban pollution, recruited through occupational health surveillance programs at ICS Maugeri and affiliated institutions, including administrative personnel from the University of Pavia. The study focuses on evaluating the relationship between urban environmental exposure, lifestyle factors, biological aging, inflammation, oxidative stress, and epigenetic modifications.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older;
- Male or female participants;
- Ability and willingness to provide written informed consent;
- Employment in occupations performed predominantly outdoors in an urban environment with exposure to atmospheric pollution, i.e. employment as urban police officers, police personnel, public transport workers, taxi drivers, newsstand workers, or other outdoor urban workers in the city of Pavia;
- Employment in predominantly indoor office-based occupations with minimal occupational exposure to outdoor urban air pollution (control group), i.e. workers undergoing occupational health surveillance at ICS Maugeri or affiliated institutions.
Key exclusion criteria (5 listed)
- Current diagnosis of active oncological disease;
- Current treatment with immunosuppressive therapy;
- Inability or unwillingness to provide informed consent;
- Medical conditions preventing participation in blood sampling or study assessments;
- Pregnancy or breastfeeding (if applicable and according to Ethics Committee recommendations).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DNA Methylation Profile Associated With Urban Air Pollution Exposure
Time frame: Baseline
DNA methylation patterns are evaluated in peripheral blood samples from participants exposed to different levels of urban air pollution. Genomic DNA is extracted and analyzed using bisulfite sequencing, quantitative polymerase chain reaction (qPCR), and pyrosequencing techniques to quantify DNA methylation in specific genomic regions. Methylation measures are evaluated in relation to participants' measured exposure to urban air pollutants.
1 secondary outcome
Biological Age Estimated using an Epigenetic Clock Analysis in Workers Exposed to Urban Air Pollution
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Stefano M Candura, MD, Prof. principal investigator
Occupational medicine Unit, ICS Maugeri IRCCS, Pavia, Italy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult Participants, run by University of Pavia at 1 site in Italy.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA Methylation Profile Associated With Urban Air Pollution Exposure (time frame: Baseline). 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 14 Sep 2026.