Clinical Trials Logo
NCT number NCT03395119
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact James Samet, PhD
Phone (919) 966-0665
Status Not yet recruiting
Phase Phase 1
Start date January 2018
Completion date December 18, 2020

Clinical Trial Summary

Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollution. One of the common air pollutants, ozone, has been shown to induce oxidative stress and inflammation in the cardiovascular and respiratory systems. This proposed study is to examine the efficacy of fish oil and olive oil in modulating cardiovascular and pulmonary functions after ozone exposure. The objective is to understand the mechanistic basis for the health effects of ozone relative to those air pollutants. Treatment groups will include forty healthy young adults who will be given dietary supplementation of fish oil or olive oil. A control group will consist of 20 healthy volunteers who will receive no supplements. After 4 weeks, subjects will be exposed to clean air for 2 hours on the first day, then ozone for 2 hours on the second day. Cardiac rhythm, pulmonary function, vascular responses, endothelial function, and markers of coagulation and airway inflammation pre- and post- ozone exposure will be measured. This study is designed to build on the previous nutritional supplement interventional studies (UNC IRB # 07-0190 and UNC IRB # 11-1807), in order to understand the mechanism of action of particulate pollutants in comparison to that of ozone, a known oxidant air contaminant.

Participants: A total of sixty healthy 18-35 year-old male and female subjects will be involved in the study.

Procedures (methods): Forty healthy young adults will receive dietary supplementation consisting of fish oil or olive oil for 4 weeks. The control group includes 20 healthy volunteers who will receive no supplements in the study. After 4 weeks of supplementation or control regiment, each subject will be exposed to clean air for 2 hours on the first day, then ozone for 2 hours on the second day.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

See also
  Status Clinical Trial Phase
Terminated NCT00001844 - Study of New Magnetic Resonance Methods N/A
Enrolling by invitation NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Recruiting NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Active, not recruiting NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A
Recruiting NCT03259464 - This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated Phase 1
Recruiting NCT03224702 - First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers Phase 1
Recruiting NCT03114839 - Effect of Lactobacillus Casei Shirota on the Small Intestinal Microbiota (ROBIN) N/A
Completed NCT03309566 - Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir Phase 4
Completed NCT00527579 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB Phase 1
Completed NCT00526916 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28 Phase 1
Recruiting NCT03277612 - Effects of C-section Delivery on Infant Brain Development N/A
Recruiting NCT02509494 - Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2 Phase 3
Terminated NCT02555085 - Single Ascending Doses of BIIB063 in Healthy Volunteers Phase 1
Completed NCT03125018 - Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX) N/A
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT00004556 - The Effects of Dextroamphetamine on Brain Function N/A
Completed NCT00091533 - Neural Correlates of Observation of Tactile Stimulation in Healthy Subjects N/A
Completed NCT00068926 - VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases N/A
Recruiting NCT03280173 - A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood Phase 1
Completed NCT02947139 - Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers Phase 1