Noise, Oxidative Stress and Cardiovascular System (NOXYCARD)

Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity.

Study Overview

• Status: Not yet recruiting
• Conditions: Noise Exposure; Noise; Adverse Effect
• Intervention / Treatment: Other: Exposure to loud pre-recorded road traffic noise

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Branko Jakovljevic, MD, PhD; Phone Number: +381113612762; Email: jakovljevic@dr.com

Study Locations

• Serbia
  • Beograd
    • Belgrade, Beograd, Serbia, 11040
      • Faculty of Medicine, University of Belgrade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All persons who visit the Nutrition Counselling Unit of the Institute of Hygiene and Medical Ecology, located at the Faculty of Medicine, University of Belgrade will be eligible to participate in the study. The study population will include 75 participants with normal weight and 75 overweight/obese participants who meet the inclusion criteria for the survey. Participants will be informed of the protocol and sign an informed consent form.

Description

Inclusion Criteria:

• age 18-65
• both genders
• good self-reported health

Exclusion Criteria:

• diabetes mellitus
• arterial hypertension or other cardiovascular diseases
• kidney diseases
• pregnancy
• malignant diseases
• mental diseases

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with normal body weight; The effects of noise exposure on blood pressure, cardiovascular and hemodynamic parameters, stress hormones, and markers of oxidative stress and inflammation in individuals with normal body weight.	Other: Exposure to loud pre-recorded road traffic noise; Participants of both arms will be exposed to the same loud pre-recorded road traffic noise in a laboratory setting.
Overweight / obese participants; The effects of noise exposure on blood pressure, cardiovascular and hemodynamic parameters, stress hormones, and markers of oxidative stress and inflammation in individuals with overweight/obesity.	Other: Exposure to loud pre-recorded road traffic noise; Participants of both arms will be exposed to the same loud pre-recorded road traffic noise in a laboratory setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Systolic blood pressure in mmHg, higher values indicate high risk	10, 40, and 50 minutes
Concentration of stress hormone	Cortisol level in mcg/dL, higher values indicate high risk	10, 40, and 50 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic blood pressure	Diastolic blood pressure in mmHg, higher values indicate high risk	10, 40, and 50 minutes
Concentration of inflammation parameters	Interleukin-1-Beta levels in pg/mL, higher values indicate high risk	10, 40, and 50 minutes

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Principal Investigator: Katarina Paunovic, MD, PhD, Faculty of Medicine, University of Belgrade

Publications and helpful links

General Publications

• Paunovic K, Jakovljevic B, Stojanov V. The timeline of blood pressure changes and hemodynamic responses during an experimental noise exposure. Environ Res. 2018 May;163:249-262. doi: 10.1016/j.envres.2018.01.048. Epub 2018 Feb 22.
• Paunovic K, Stojanov V, Jakovljevic B, Belojevic G. Thoracic bioelectrical impedance assessment of the hemodynamic reactions to recorded road-traffic noise in young adults. Environ Res. 2014 Feb;129:52-8. doi: 10.1016/j.envres.2014.01.001. Epub 2014 Jan 25.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1322-IX/42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared. Data will be shared in cumulative form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No