An observational study in Healthy Adult Participants, sponsored by University of Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by University of Pavia · Observational
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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:
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:
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.
264 studies on the registry are indexed under Tobacco Smoking; 42 are open to participants now.
This study's enrollment of 151 is below the median of 492 across 30 observational studies indexed under Tobacco Smoking.
Browse Tobacco Smoking studies →University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: Baseline
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.
Time frame: Baseline
Blood Glucose Concentration
Blood glucose concentration measured from the peripheral blood sample to characterize glucose metabolism. Unit: mg/dL
Time frame: Baseline
Serum Insulin Concentration
Serum insulin concentration measured to characterize glucose and insulin metabolism. Unit: mIU/L
Time frame: Baseline
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is calculated from fasting glucose and insulin concentrations as an estimate of insulin resistance.
Time frame: Baseline
Mean Corpuscular Volume
Mean corpuscular volume (MCV) measured as part of the complete blood count. Unit: fL
Time frame: Baseline
Hemoglobin Concentration
Hemoglobin concentration measured in peripheral blood as part of the complete blood count. Unit: g/L
Time frame: Baseline
Leukocyte Count
Leukocyte count measured in peripheral blood as part of the complete blood count. Unit: 10\^9/L
Time frame: Baseline
Leukocyte Telomere Length in Relation to Urban Air Pollution Exposure
Telomere length is measured in peripheral blood leukocytes as a biomarker of biological aging and cellular senescence. Analyses evaluate associations between telomere length and exposure to urban air pollutants.
Time frame: Baseline
Creatinine Concentration
Serum Creatinine Concentration. Unit: mg/dL
Time frame: Baseline
Estimated Glomerular Filtration Rate
Estimated glomerular filtration rate (eGFR) used to characterize renal function. Unit: mL/min/1.73 m²
Time frame: Baseline
Serum Folate Concentration
Unit: µg/L
Time frame: Baseline
Serum Vitamin B12 Concentration
Unit: ng/L
Time frame: Baseline
Plasma Homocysteine Concentration
Unit: µmol/L
Time frame: Baseline
FIB-4 Index
FIB-4 is a non-invasive index of liver fibrosis calculated from age, AST, ALT, and platelet count.
Time frame: Baseline
Aspartate Aminotransferase (AST) Concentration
Unit: U/L
Time frame: Baseline
Alanine Aminotransferase (ALT) Concentration
Unit: U/L
Time frame: Baseline
Gamma-Glutamyl Transferase Concentration
Unit: U/L
Time frame: Baseline
Total Cholesterol Concentration
Unit: mg/dL
Time frame: Baseline
HDL Cholesterol Concentration
Unit: mg/dL
Time frame: Baseline
LDL Cholesterol Concentration
Unit: mg/dL
Time frame: Baseline
Triglyceride Concentration
Unit: mg/dL
Time frame: Baseline
Serum 25-Hydroxyvitamin D Concentration
Unit: µg/L
Time frame: Baseline
Serum Thyroid-Stimulating Hormone (TSH) Concentration
Unit: mUI/L
Time frame: Baseline
Serum Free Triiodothyronine (FT3) Concentration
Unit: ng/L
Time frame: Baseline
Serum Free Thyroxine (FT4) Concentration
Unit: ng/dL
Time frame: Baseline
Anti-Thyroglobulin Antibody Concentration
Unit: KUI/L
Time frame: Baseline
Anti-Thyroid Peroxidase Antibody Concentration
Unit: KUI/L
Time frame: Baseline
Body Mass Index (BMI)
Body mass index (BMI) is calculated as body weight in kilograms divided by height in meters squared (kg/m²) and is used to assess overall body size.
Time frame: Baseline
Waist-to-Hip Ratio (WHR)
Waist-to-hip ratio (WHR) is calculated from waist and hip circumference measurements as an indicator of body fat distribution.
Time frame: Baseline
Waist-to-height ratio (WHtR)
Waist-to-height ratio (WHtR) is calculated from waist circumference and height measurements as an indicator of central adiposity.
Time frame: Baseline
Bioelectrical Impedance Phase Angle
Phase angle is measured by bioelectrical impedance analysis using the BIA 101 device (BIVA® PRO, Akern) as an indicator of cellular integrity and body composition status. Phase angle is reported in degrees.
Time frame: Baseline
Handgrip Strength
Handgrip strength is measured using a digital handgrip dynamometer (GripwiseTech). 3 test on non dominant hand are repeated and the mean value is used as an indicator of handgrip strenght.
Time frame: Baseline
Liver Stiffness Measured by Transient Elastography
Liver stiffness is measured by transient elastography (FibroScan® Compact 530, Echosens SA) and reported in kilopascals (kPa).
Time frame: Baseline
Controlled Attenuation Parameter (CAP)
The Controlled Attenuation Parameter (CAP) is measured by transient elastography (FibroScan® Compact 530, Echosens SA) to estimate hepatic steatosis.
Time frame: Baaseline
Mediterranean Diet Adherence score (Medi-Lite)
Adherence to the Mediterranean diet is assessed using the validated MEDI-LITE questionnaire (doi: 10.1080/09637486.2017.1287884.). The questionnaire evaluates the usual consumption of nine dietary components: fruit, vegetables, legumes, cereals, fish and fish products, meat and processed meat, milk and dairy products, alcoholic beverages, and olive oil. Each component is assigned a score ranging from 0 to 2. For food groups characteristic of the Mediterranean dietary pattern (i.e. fruit, vegetables, legumes, cereals, and fish), higher consumption is assigned a higher score, whereas lower consumption of meat and processed meat and milk and dairy products received a higher score. Olive-oil use is scored according to its reported frequency of consumption. The original MEDI-LITE score ranges from 0 to 18, with higher values indicating greater adherence to the Mediterranean dietary pattern.
Time frame: Baseline
Dietary Inflammatory Index (DII)
The Dietary Inflammatory Index (DII) is calculated from dietary intake data obtained through a 24-hour dietary recall collected through the Handydiet® software to estimate the inflammatory potential of participants' diets.
Time frame: Baseline
Physical Activity Level (IPAQ-SF)
Physical activity is assessed using the validated International Physical Activity Questionnaire Short Form (IPAQ-SF). The seven-item questionnaire investigates the frequency and duration of walking and moderate- and vigorous-intensity physical activity performed during the previous seven days, together with time spent sitting. Weekly physical activity was expressed as metabolic equivalent of task minutes per week (MET-min/week), calculated by multiplying the MET coefficient assigned to each activity intensity by the reported duration and weekly frequency of the activity. Participants were classified as having low, moderate, or high physical activity levels according to the IPAQ scoring protocol (doi: 10.1249/01.MSS.0000078924.61453.FB.).
Time frame: Baseline
Sleep Quality (PSQI)
Sleep quality during the previous month is assessed using the Pittsburgh Sleep Quality Index (PSQI) (doi: 10.1016/0165-1781(89)90047-4. PMID: 2748771.). The PSQI comprises 19 self-rated items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, and the seven component scores are summed to generate a global score ranging from 0 to 21. Higher scores, and in particular a cut-off of 5, indicate poorer subjective sleep quality.
Time frame: Baseline
Quality of Life (WHOQOL-BREF)
Quality of life is assessed using the abbreviated version of the World Health Organization Quality of Life questionnaire (doi: 10.1017/s0033291798006667.). The WHOQOL-BREF comprises 26 items, including two general questions on overall quality of life and perceived health and 24 items covering four domains: physical health, psychological health, social relationships, and environment. Items are rated using five-point response scales. Domain scores are calculated according to the instrument scoring guidelines and transformed to a 4-20 or 0-100 scale, with higher scores indicating better perceived quality of life.
Time frame: Baseline
Alcohol consumption pattern
Alcohol consumption is assessed through a structured interview investigating drinking frequency and the usual number of Alcohol Units consumed per each drinking occasion. Participants are classified as reporting no current alcohol consumption, alcohol consumption without a binge pattern, or binge-pattern alcohol consumption. Binge-pattern drinking is defined as the consumption of at least four Alcohol Units for women or at least five Alcohol Units for men on a single drinking occasion. One alcohol Unit equals to 12g of ethanol and is approximately equivalent to the quantity of alcohol in a bottle (330 ml) of beer, in a glass (125 ml) of wine, in a shot (40 ml) of spirit.
Time frame: Baseline
Smoking status
Smoking habits are assessed through a structured interview. Participants are classified as current, former, or never smokers. Additional information collected includes the average number of cigarettes smoked per day and the duration of smoking for current and former smokers.
Time frame: Baseline
Personal exposure to Ozone (O₃) in warm season
Personal exposure to ozone (O₃) is assessed in warm season using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Personal Exposure to Nitrogen Dioxide (NO₂)
Personal exposure to nitrogen dioxide (NO₂) is assessed using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Personal Exposure to Sulfur Dioxide (SO₂)
Personal exposure to sulfur dioxide (SO₂) is assessed using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Personal Exposure to Benzene (C₆H₆)
Personal exposure to Benzene (C₆H₆) is assessed using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Personal exposure to Toluene
Personal exposure to toluene is assessed using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Personal exposure to Ethylbenzene
Personal exposure to ethylbenzene is assessed using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Personal exposure to Xylenes
Personal exposure to xylenes is assessed using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Personal exposure to Naphthalene
Personal exposure to naphthalene is assessed using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Personal exposure to C9 Aromatic Hydrocarbons
Personal exposure to C9 aromatic hydrocarbons is assessed using passive diffusion samplers worn by participants during their usual daily activities over a five consecutive day monitoring period. Unit of measure: µg/m3
Time frame: Baseline
Serum Chemokine CCL2 Concentration
Serum CCL2 concentration is measured to assess systemic inflammatory responses associated with urban air pollution exposure. CCL2 concentrations are analyzed in relation to participants' measured exposure to urban air pollutants. Unit of measure: pg/mL
Time frame: Baseline
Serum Chemokine CXCL8 Concentration
Serum CXCL8 concentration is measured to assess systemic inflammatory responses associated with urban air pollution exposure. CXCL8 concentrations are analyzed in relation to participants' measured exposure to urban air pollutants. Unit of measure: pg/mL
Time frame: Baseline
Serum Chemokine CXCL10 Concentration
Serum CXCL10 concentration is measured to assess systemic inflammatory responses associated with urban air pollution exposure. CXCL10 concentrations are analyzed in relation to participants' measured exposure to urban air pollutants. Unit of measure: pg/mL
Time frame: Baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2024 to primary completion in Oct 2025, 11 months.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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