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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 64
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Lithuania
Department of Family Medicine, Lithuanian University of Health Sciences
RECRUITING
Kaunas
Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences
NOT_YET_RECRUITING
Kaunas
Contact Information
Primary
Regina Grazuleviciene, prof.
regina.grazuleviciene@vdu.lt
+37065027090
Backup
Sandra Andrusaityte, dr.
sandra.andrusaityte@vdu.lt
+37068437989
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2028-12
Participants
Target number of participants: 180
Treatments
No_intervention: Control group (usual routine)
Participants in this group will continue their regular daily activities without any changes imposed. They will not receive specific instructions on physical activity or diet but will undergo the same measurements and monitoring as other groups for comparison purposes.
Experimental: Green Space Activity Group - Daily Physical Activity
Participants in this group will be instructed to take a brisk 30-minute walk each day in designated urban green spaces (e.g., parks, forested areas). Physical activity will be monitored using Fitbit Alta wristband sensors to track duration, intensity, and steps.
Experimental: Mediterranean Diet Group - Dietary Intervention
Participants in this group will follow the principles of the Mediterranean diet, including increased consumption of fruits, vegetables, whole grains, legumes, nuts, and olive oil, and reduced intake of red meat and processed foods. They will receive dietary guidance and support for meal planning throughout the 7-day intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Lithuanian University of Health Sciences
Leads: Regina Grazuleviciene

This content was sourced from clinicaltrials.gov