NCT07111208 Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
| NCT ID | NCT07111208 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Grazuleviciene |
| Condition | Cardiovascular Diseases (CVD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-10-24 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study, combining both an observational study and an interventional clinical trial, aims to assess how exposure to ultrafine particulate matter (PM0.1) and noise pollution affects the risk of cardiovascular diseases and metabolic disorders in 45-64-year-old residents of Kaunas City, and whether lifestyle interventions-specifically physical activity in green spaces and the Mediterranean diet-can help reduce these risks. In the observational part, approximately 1,000 randomly selected 45-64 years men and women living in private households will complete an anonymous online health and lifestyle questionnaire. The clinical interventional trial will include 180 participants, who agreed to participate in the clinical study and, who meet specific health criteria. The main questions the study seeks to answer are: whether increased exposure to PM0.1 and noise is linked to higher cardiovascular and metabolic risk; and whether short-term healthy lifestyle changes can improve biological markers associated with these conditions. Participants in the clinical trial will be randomly assigned to one of three groups: (1) control group continuing usual habits, (2) physical activity group at least 30-minute daily walks in green spaces, or (3) group adherence to a Mediterranean diet. They will have two visits to the clinic for health surveys: * Wear a wristband sensor for 7 days to monitor physical activity, heart rate, and sleep quality * Visit a clinic on Day 1 and Day 8 for measurements (blood pressure, waist circumference, body composition) and give blood samples for biomarker analysis. This research will provide new evidence on environmental health risks and practical recommendations for reducing the burden of metabolic and cardiovascular diseases.
Eligibility 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
Contact & Investigator
Regina Grazuleviciene, prof.
PRINCIPAL INVESTIGATOR
Vytautas Magnus University
Frequently Asked Questions
Who can join the NCT07111208 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 64 Years, studying Cardiovascular Diseases (CVD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111208 currently recruiting?
Yes, NCT07111208 is actively recruiting participants. Contact the research team at regina.grazuleviciene@vdu.lt for enrollment information.
Where is the NCT07111208 trial being conducted?
This trial is being conducted at Kaunas, Lithuania, Kaunas, Lithuania.
Who is sponsoring the NCT07111208 clinical trial?
NCT07111208 is sponsored by Regina Grazuleviciene. The principal investigator is Regina Grazuleviciene, prof. at Vytautas Magnus University. The trial plans to enroll 180 participants.