Noise, Oxidative Stress and Cardiovascular System
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Belgrade
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age 18-65
both genders
good self-reported health
Disqualifiers
diabetes mellitus
arterial hypertension or other cardiovascular diseases
kidney diseases
pregnancy
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Exposure to loud pre-recorded road traffic noise
Other interventionParticipants of both arms will be exposed to the same loud pre-recorded road traffic noise in a laboratory setting.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Participants with normal body weight1 intervention
Group B: Overweight / obese participants1 intervention
Trial outcomes
Primary outcomes
1
Systolic blood pressure
Systolic blood pressure in mmHg, higher values indicate high risk
Time frame
10, 40, and 50 minutes2
Concentration of stress hormone
Cortisol level in mcg/dL, higher values indicate high risk
Time frame
10, 40, and 50 minutesSecondary outcomes
1
Diastolic blood pressure
Diastolic blood pressure in mmHg, higher values indicate high risk
Time frame
10, 40, and 50 minutes2
Concentration of inflammation parameters
Interleukin-1-Beta levels in pg/mL, higher values indicate high risk
Time frame
10, 40, and 50 minutesSponsors and contacts
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Source ClinicalTrials.gov
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