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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Prevalence of cardiovascular diseases (CVD)
研究概览
简要总结
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.
详细描述
The METSGREEN study is a hybrid biomedical research project combining an observational environmental-epidemiological study with an experimental clinical trial of healthy behavior. It is implemented under the international MARKOPOLO project framework, funded by the European Commission through the Horizon Europe program. The study is led in Lithuania by Vytautas Magnus University (VMU), with contributions from 15 academic institutions across Europe and North America. METSGREEN aims to explore the impact of ultrafine particulate matter (PM0.1) and noise exposure on cardiometabolic health in middle-aged urban populations and assess whether targeted lifestyle interventions can mitigate these effects.
Scientific Background and Rationale: Environmental pollution is increasingly recognized as a major contributor to chronic non-communicable diseases. Ultrafine particles (diameter <0.1 µm) are especially harmful due to their ability to penetrate deep into the respiratory tract, cross alveolar membranes, and enter systemic circulation. These particles trigger oxidative stress, systemic inflammation, endothelial dysfunction, and coagulation disorder processes implicated in the pathogenesis of metabolic syndrome and cardiovascular diseases (CVD). Epidemiological studies suggest a strong link between long-term exposure to PM0.1 and increased incidence of hypertension, diabetes, central obesity, and other metabolic risk factors. Moreover, urban noise exposure has been shown to exacerbate cardiovascular risks through stress-mediated neuroendocrine pathways. However, many of these associations remain insufficiently understood, particularly in populations with specific vulnerabilities, such as older age or lower socioeconomic status.
Nature-based interventions such as physical activity in green spaces are a promising strategy to counteract these effects. Regular exposure to nature has been shown to improve autonomic nervous system balance, reduce cortisol levels, and promote cardiovascular resilience. Dietary interventions, particularly the Mediterranean diet, rich in unsaturated fats, antioxidants, and anti-inflammatory nutrients, are also recognized for their cardioprotective effects. Despite this, very few studies integrate objective environmental exposure assessments with clinical lifestyle interventions and biomarker-based outcomes.
Study Objectives: The study is divided into two core components with distinct but complementary objectives:
- Observational Study (n = 1,000): Model and map environmental exposure to PM0.1 and noise across Kaunas city using land-use regression (LUR) based on data collected at 20 strategic locations. Link environmental exposure estimates to self-reported health status, lifestyle factors, and socioeconomic characteristics using a standardized, anonymized online questionnaire. Assess associations between PM0.1/noise exposure and key cardiometabolic indicators: prevalence of cardiovascular disease, blood pressure, waist circumference, and anthropometric data. Investigate potential effect modifiers such as sex, age, residential environment, and economic status.
- Experimental Clinical Trial (n = 180): Assess the short-term impact of a healthy lifestyle intervention on metabolic health indicators and biological markers in individuals with early signs of metabolic syndrome (central obesity and/or elevated blood pressure). Compare three groups (1:1:1 allocation): control (no intervention), physical activity in green space (daily 30-minute brisk walk), and Mediterranean diet intervention (dietary counselling and meal planning). Evaluate changes in biological markers (HDL, triglycerides, fasting glucose, body composition, blood pressure, etc.) and omics-level indicators (metabolomics, proteomics, DNA methylation). Determine the interaction between environmental exposure levels and response to lifestyle changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unstable angina or cardiomyopathy
- •Blood pressure >160/110 mmHg
- •Neurological diseases or limited mobility
- •Presence of a cardiac pacemaker
- •Pregnancy
- •Alcohol dependence
研究组 & 干预措施
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.
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.
干预措施: Green Space Activity Group - Daily Physical Activity (Behavioral)
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.
干预措施: Mediterranean Diet Group - Dietary Intervention (Behavioral)
结局指标
主要结局
Prevalence of cardiovascular diseases (CVD)
时间窗: Baseline and 12 months.
Assessed using standardized questionnaire; Unit: % of participants with diagnosed CVD.
Blood pressure levels
时间窗: Baseline and 12 months.
measured with automated sphygmomanometer; Unit: mmHg (systolic and diastolic).
Waist circumference
时间窗: Baseline and 12 months.
measured with standard measuring tape. Unit: cm.
Anthropometric measurements (BMI)
时间窗: Baseline and 12 months.
Body Mass Index (BMI) calculated by dividing weight in kilograms by the square of height in meters (kg/m²) Measured using a calibrated scale and stadiometer; Unit: kg/m²
次要结局
- Waist circumference(Baseline and after 7-day lifestyle intervention.)
- Blood pressure levels(Baseline and after 7-day lifestyle intervention)
- High-density lipoprotein (HDL)(Baseline and after 7-day lifestyle intervention.)
- Triglycerides(Baseline and after 7-day lifestyle intervention.)
- Plasma glucose(Baseline and after 7-day lifestyle intervention.)
- Biological markers from metabolomics, proteomics, and DNA methylation(through study completion, an average of 3 years.)
研究者
Regina Grazuleviciene
professor
Vytautas Magnus University
