Actively Recruiting

Phase Not Applicable
Age: 45Years - 64Years
All Genders
ID07111208

Noise and Ultrafine Particulate Matter Induced Cardiovascular and Cerebral Damage and Lifestyle Intervention to Reduce Cardiovascular Health Risk

Led by Regina Grazuleviciene · Updated on 2025-11-28

180

Participants Needed

2

Research Sites

126 weeks

Total Duration

On this page

Sponsors

R

Regina Grazuleviciene

Lead Sponsor

L

Lithuanian University of Health Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how exposure to ultrafine particulate matter (PM0.1) and noise pollution affects the risk of cardiovascular diseases and metabolic disorders in adults aged 45 to 64 living in Kaunas City. The study combines an observational survey of about 1,000 residents with a clinical trial involving 180 participants who show early signs of metabolic syndrome. The goal is to see if these environmental factors increase health risks and whether lifestyle changes can help reduce them. In the clinical trial, participants are randomly assigned to one of three groups: a control group maintaining their usual habits, a group encouraged to take daily 30-minute brisk walks in green spaces, and a group following a Mediterranean diet with dietary counseling. The interventions last for 7 days, during which physical activity is tracked with wristband sensors, and dietary intake is supervised. Participants visit the clinic twice, on Day 1 and Day 8, for health measurements and blood sample collection. Participants complete health and lifestyle questionnaires, wear wristband sensors to monitor activity, heart rate, and sleep, and undergo clinical assessments including blood pressure, waist circumference, body composition, and blood tests for metabolic and inflammatory markers. Researchers analyze these data to understand the impact of environmental exposure and lifestyle changes on cardiovascular and metabolic health. The study's findings aim to guide public health strategies to reduce disease risks related to pollution and lifestyle.

CONDITIONS

Brief Title

Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)

Who Can Participate

Age: 45Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45 to 64 years
  • Residence in Kaunas City
  • Presence of metabolic disorder indicators such as increased waist circumference or elevated blood pressure
  • Willingness to participate and provide written informed consent
  • Agreement to wear a wristband sensor continuously for 7 days
Not Eligible

You will not qualify if you...

  • Unstable angina or cardiomyopathy
  • Blood pressure higher than 160/110 mmHg
  • Neurological diseases or limited mobility
  • Presence of a cardiac pacemaker
  • Pregnancy
  • Alcohol dependence

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Lifestyle Intervention

Duration - 7 days

Participants are randomly assigned to one of three groups: control group continuing usual routine, a group performing daily 30-minute brisk walks in urban green spaces, or a group following a Mediterranean diet with dietary guidance. Compliance and activity are monitored during this period.

2 clinical assessments (Day 1 and Day 8) at the Family Medicine Clinic

Long-term Monitoring

Duration - Up to 3 years

Participants' cardiovascular health and biological markers are assessed over time to observe long-term effects of environmental exposure and lifestyle interventions.

Assessments at baseline and 12 months; biomarker analysis through study completion

Trial Site Locations

Total: 2 locations

1

Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences

Kaunas, Kaunas County, Lithuania, 53361

Not Yet Recruiting

2

Department of Family Medicine, Lithuanian University of Health Sciences

Kaunas, Lithuania, 44248

Actively Recruiting

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Research Team

R

Regina Grazuleviciene, prof.

S

Sandra Andrusaityte, dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Ambient air and noise pollution effect on cardiovascular health risk and lifestyle intervention to attenuate it: study protocol for a randomized clinical trial.

Regina Grazuleviciene, Sandra Andrusaityte, Audrius Dedele...

https://pubmed.ncbi.nlm.nih.gov/41668846