[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316096":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":46,"centralContacts":51,"locations":52,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":51,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":96,"whyStopped":51,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"No Supplements","SHAM_COMPARATOR","The control group includes 20 healthy volunteers who will receive no supplements in the study. 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",[13],"Drug: Ozone",{"label":15,"type":16,"description":17,"interventionNames":18},"Fish oil","EXPERIMENTAL","Twenty healthy young adults will receive fish oil supplements for 4 weeks. 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",[13,19],"Dietary Supplement: Fish Oil",{"label":21,"type":16,"description":22,"interventionNames":23},"Olive oil","Twenty healthy young adults will receive olive oil supplements for 4 weeks. 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",[13,24],"Dietary Supplement: Olive Oil",[26,33,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Ozone","After the four-week supplementation period, each subject will be blindly exposed on consecutive days to filtered air for 2 hours and to 0.3 ppm ozone for 2 hours, while undergoing intermittent moderate exercise (minute ventilation of 20 L\u002Fmin\u002Fm²).",[15,9,21],[32],"Filtered air",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DIETARY_SUPPLEMENT","Fish Oil","3 (1-gram) soft-gels daily Commercially available, enteric-coated, soft-gels formulated to deliver \\>60% eicosapentaenoic\u002Fdocosahexaenoic acids (EPA\u002FDHA)",[15],[39],"omega-3 fatty acids (eicosapentaenoic\u002Fdocosahexaenoic)",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Olive Oil","3 soft-gels daily Commercially available soft-gels containing 1 gram of USDA organic certified, cold pressed, extra virgin, olive oil",[21],[45],"extra virgin olive oil",[47],{"name":48,"affiliation":49,"role":50},"James Samet, PhD","Environmental Protection Agency, University of North Carolina at Chapel Hil","PRINCIPAL_INVESTIGATOR",null,[53],{"facility":54,"status":51,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":51},"U.S. Environmental Protection Agency Human Studies Facility","Chapel Hill","North Carolina","27514","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-79.05584,35.9132,{"lat":64,"lon":63},{"type":67,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR",[69],{"name":70,"class":71},"Environmental Protection Agency (EPA)","FED","100316096","phase-1-efficacy-of-fish-oil-or-olive-oil-supplementation-on-the-health-effects-of-ozone-exposure-in-healthy-young-subjects-100316096",false,"NCT03395119","Efficacy of Fish Oil or Olive Oil Supplementation on the Health Effects of Ozone Exposure in Healthy Young Subjects","OMEGOZ","Inclusion Criteria:\n\n* Age 18-35 years old healthy male and female (19≤BMI≤30).\n* Physical conditioning allowing intermittent, moderate exercise for 2 hours, and ability to complete the exposure exercise regimen chosen to induce a minute ventilation rate of 20 L\u002Fmin\u002Fm² for 15 minutes without exceeding 80% of predicted maximal heart rate.\n* Normal resting electrocardiography (ECG)\n* Normal lung function\n* Oxygen saturation greater than 94% at the time of physical exam.\n* Individuals whose blood omega-3 index is 5% or lower at the time of screening.\n\nExclusion Criteria:\n\n1. Individuals with a history of acute or chronic cardiovascular disease, chronic respiratory disease, cancer (possible exception for history of non-melanoma skin cancer), rheumatologic disease, neuromuscular disease, or immunodeficiency state.\n2. Individuals with a cardiovascular disease risk score greater than 10% using the American College of Cardiology and the American Heart Association Atherosclerotic Cardiovascular Disease risk calculator. (Based on the 10-year risk of heart disease or stroke using the Atherosclerotic Cardiovascular Disease algorithm published in 2013 American College of Cardiology\u002FAmerican Heart Association Guideline on the Assessment of Cardiovascular risk.)\n3. Uncontrolled hypertension (\\>150 systolic, \\>90 diastolic).\n4. Individuals who are diabetic (previously diagnosed or with hemoglobin A1c level \\>6.4%).\n5. Individuals with asthma or a history of asthma.\n6. Individuals who are allergic to chemical vapors or gases.\n7. Individuals who have skin allergy to tape or electrodes.\n8. Individuals is pregnant, attempting to become pregnant or breastfeeding.\n9. Individuals who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study (defined as more than 1 pk\u002Fyr in the past year) or have a greater than\u002Fequal to a 5 pack year smoking history.\n10. Individuals living with a smoker who smokes inside the house.\n11. Individuals who are regularly exposed to high levels of vapors, dust, gases, or fumes.\n12. Individuals that do not understand or speak English.\n13. Individuals that are unable to perform the exercise required for the study.\n14. Individuals who are taking Î2-blocker medications.\n15. Individuals who are allergic to fish or omega-3 fatty acids, or are on prescription of taking omega-3 fish oil as therapy.\n16. Individuals that are unwilling or unable to stop taking medications that may impact the results of ozone challenge for the duration of the study. Medications not specifically mentioned here may be reviewed by the investigators prior to an individuals inclusion in the study.\n17. Individuals who are unwilling or unable to stop taking any current dietary supplements for the duration of the study. Prebiotics and probiotics are acceptable.\n18. Individuals who are unwilling or unable to adhere to study specific dietary restrictions (see details under A.4.2 dietary instruction).\n19. Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with ozone inhalation will be a basis for exclusion.\n20. Individuals with bleeding\u002Fclotting disorders.\n21. Individuals who are not willing to participate the induced sputum procedure on the training day.\n\nTemporary exclusion criteria:\n\n1. Individuals who have recent (within 6 month) abdominal and\u002For eye surgery, or with any types of hernia, as well as any other contraindications for raised intra-abdominal pressure.\n2. Individuals who have had an acute respiratory illness within 4 weeks.\n3. Individuals who are currently taking systemic steroids, oral anticoagulants, over-the counter pain medications (such as aspirin, Advil, Aleve) or nonsteroidal anti-inflammatory drugs, or have taken these medications within the last 14 days.\n4. Individuals who have active allergies.\n\nUse of other medications will be evaluated on a case-by-case basis. There is the potential that an individuals current medication use will preclude them from participating in the study at the current time, but they may be reassessed and potentially rescheduled for participation at a later time.",true,"ALL","18 Years","35 Years",{"count":84,"type":85},44,"ACTUAL","INTERVENTIONAL",[88],"PHASE1","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.\n\nParticipants: A total of sixty healthy 18-35 year-old male and female subjects will be involved in the study.\n\nProcedures (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.",[91,92],"Healthy","Dietary Supplement",[94,95],"Ozone exposure","Healthy Adults","COMPLETED","2021-01-13",{"date":99,"type":85},"2021-01-15",{"date":101,"type":85},"2017-12-18",{"date":103,"type":85},"2020-12-18",{"name":5,"class":6},1]