Ambient air and noise effects on heart and metabolic health with green-space exercise and Mediterranean diet (METSGREEN)
Noise and/or Ultrafine Particulate Matter Induced Cerebral and Cardiovascular Damage: Experimental and Epidemiological Studies (MARKOPOLO) and Lifestyle Intervention to Attenuate Cardiovascular Health Risk (METSGREEN)
This project will test whether exposure to ultrafine air pollution and urban noise raises heart and metabolic risk and whether daily green-space exercise or a Mediterranean diet can lower that risk in 45–64-year-old Kaunas residents with early metabolic problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 45 Years to 64 Years |
| Sex | All |
| Sponsor | Vytautas Magnus University Academic / other |
| Locations | 2 sites (Kaunas, Kaunas County and 1 other locations) |
| Trial ID | NCT07111208 on ClinicalTrials.gov |
What this trial studies
METSGREEN combines an observational survey of about 1,000 randomly selected 45–64-year-old Kaunas residents with a clinical intervention of 180 participants who meet metabolic risk criteria. The observational arm collects anonymous online health and lifestyle data and links individual exposure estimates for ultrafine particulate matter (PM0.1) and urban noise. The interventional arm assigns eligible participants to either daily physical activity in green spaces or a Mediterranean diet, monitors activity and exposures with wristband sensors, and measures cardiometabolic biomarkers before and after the short-term intervention. The study is led by Vytautas Magnus University with collaborators across Europe and North America as part of the MARKOPOLO project funded by Horizon Europe.
Who should consider this trial
Good fit: Ideal candidates are 45–64-year-old Kaunas residents with indicators of metabolic disorder (for example increased waist circumference or elevated blood pressure) who can consent and wear a wristband sensor.
Not a fit: People with unstable angina or cardiomyopathy, very high blood pressure (>160/110 mmHg), significant neurological or mobility limitations, a cardiac pacemaker, pregnancy, or alcohol dependence are excluded and unlikely to benefit from the short-term interventions.
Why it matters
Potential benefit: If successful, these simple lifestyle changes could provide non-drug ways to reduce cardiovascular and metabolic risk in people living in polluted cities.
How similar studies have performed: Epidemiological studies link PM0.1 and noise to cardiometabolic risk and trials show benefits from Mediterranean diet and regular exercise, but randomized interventions specifically addressing pollution-related risk are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 45-64 years * Residence in Kaunas City * Presence of metabolic disorder indicators (e.g., increased waist circumference and/or elevated blood pressure) * Willingness to participate and provide written informed consent * Agreement to wear a wristband sensor continuously for 7 days Exclusion Criteria: * Unstable angina or cardiomyopathy * Blood pressure \>160/110 mmHg * Neurological diseases or limited mobility * Presence of a cardiac pacemaker * Pregnancy * Alcohol dependence
Where this trial is running
Kaunas, Kaunas County and 1 other locations
- Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences — Kaunas, Kaunas County, Lithuania (Not_yet_recruiting)
- Department of Family Medicine, Lithuanian University of Health Sciences — Kaunas, Lithuania (Recruiting)
Study contacts
- Principal investigator: Regina Grazuleviciene, prof. — Vytautas Magnus University
- Study coordinator: Regina Grazuleviciene, prof.
- Email: regina.grazuleviciene@vdu.lt
- Phone: +37065027090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.