Efficacy of Fish Oil or Olive Oil Supplementation on the Health Effects of Ozone Exposure in Healthy Young Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in forced expired volume in the first second (FEV1) from air exposure (Day 1) to ozone exposure (Day 2)
研究概览
简要总结
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.
详细描述
Ozone pollution is a common problem across the world, including in the US. This proposed study is to examine the efficacy of fish oil and olive oil in modulating cardiovascular and pulmonary functions after ozone exposure. Results from this study will also increase our understanding of how ozone exposure adversely affects the functioning of the human cardiovascular and respiratory systems. This understanding may be especially important for patients with cardiopulmonary diseases.
Approximately 60 people will participate in this study.
You should expect to be in this study for about a month, but your participation could possibly last for 6 months. There are 4 sessions, including a consenting session (today) which will last for about 4 hours. The two exposure-day sessions will last approximately 8-9 hours each. There will also be an approximately 3-hour follow-up visit the day after your last exposure.
What will happen if you take part in the study? Before you agree to participate in this study, you must read the consent forms in their entirety. The research and medical staff will then answer all your questions and explain all the risks involved in this study to your satisfaction.
You should have already undergone a general physical examination to ensure that you are a suitable candidate for this study. If you are a female, you will be asked about your menstrual history. For all other female participants, a pregnancy test will be performed today, and this will be repeated on the exposure day if more than 7 days since last pregnancy test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Both participant and investigators are blinded for the assignment of dietary supplementation of fish oil, olive oil or control.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-35 years old healthy male and female (19≤BMI≤30).
- •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/min/m² for 15 minutes without exceeding 80% of predicted maximal heart rate.
- •Normal resting electrocardiography (ECG)
- •Normal lung function
- •Oxygen saturation greater than 94% at the time of physical exam.
- •Individuals whose blood omega-3 index is 5% or lower at the time of screening.
排除标准
- •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.
- •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/American Heart Association Guideline on the Assessment of Cardiovascular risk.)
- •Uncontrolled hypertension (>150 systolic, >90 diastolic).
- •Individuals who are diabetic (previously diagnosed or with hemoglobin A1c level >6.4%).
- •Individuals with asthma or a history of asthma.
- •Individuals who are allergic to chemical vapors or gases.
- •Individuals who have skin allergy to tape or electrodes.
- •Individuals is pregnant, attempting to become pregnant or breastfeeding.
- •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/yr in the past year) or have a greater than/equal to a 5 pack year smoking history.
- •Individuals living with a smoker who smokes inside the house.
- •Individuals who are regularly exposed to high levels of vapors, dust, gases, or fumes.
- •Individuals that do not understand or speak English.
- •Individuals that are unable to perform the exercise required for the study.
- •Individuals who are taking Î2-blocker medications.
- •Individuals who are allergic to fish or omega-3 fatty acids, or are on prescription of taking omega-3 fish oil as therapy.
- •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.
- •Individuals who are unwilling or unable to stop taking any current dietary supplements for the duration of the study. Prebiotics and probiotics are acceptable.
- •Individuals who are unwilling or unable to adhere to study specific dietary restrictions (see details under A.4.2 dietary instruction).
- •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.
- •Individuals with bleeding/clotting disorders.
- •Individuals who are not willing to participate the induced sputum procedure on the training day.
- •Temporary exclusion criteria:
- •Individuals who have recent (within 6 month) abdominal and/or eye surgery, or with any types of hernia, as well as any other contraindications for raised intra-abdominal pressure.
- •Individuals who have had an acute respiratory illness within 4 weeks.
- •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.
- •Individuals who have active allergies.
- •Use 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.
研究组 & 干预措施
No Supplements
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
干预措施: Ozone (Drug)
Fish oil
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
干预措施: Ozone (Drug)
Fish oil
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
干预措施: Fish Oil (Dietary Supplement)
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
干预措施: Ozone (Drug)
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
干预措施: Olive Oil (Dietary Supplement)
结局指标
主要结局
Change in forced expired volume in the first second (FEV1) from air exposure (Day 1) to ozone exposure (Day 2)
时间窗: Day 1, Day 2
FEV1 is determined by spirometry
次要结局
- endothelial cell function 18 hour post-exposure(1 hour pre-exposure, 18 hour post-exposure)
- diameters of retinal arteries and veins 18 hour post-exposure(30 min pre-exposure, 18 hour post-exposure)
- airway inflammation 4 hour post-exposure(6 weeks prior to the exposure, 4 hour post-exposure)
- Blood fatty acids 30 min post-exposure(2 hour pre-exposure, 30 min post-exposure)
- Blood fatty acids 2 hour post-exposure(6 weeks prior to the exposure, 2 hours pre-exposure)
- Blood cholesterol 2 hour post-exposure(6 weeks prior to the exposure, 2 hours pre-exposure)
- diameters of retinal arteries and veins 1 hour post-exposure(30 min pre-exposure, 1 hour post-exposure)
- Heart rate variability 1 hour post-exposure(1 hour pre-exposure, 1 hour post-exposure)
- Heart rate variability 18 hour post-exposure(1 hour pre-exposure, 18 hour post-exposure)
- Blood fatty acids 18 hour post-exposure(2-hour pre-exposure, 18 hour post-exposure)
- Blood cholesterol 30 min post-exposure(2 hour pre-exposure, 30 min post-exposure)
- Blood cholesterol 18 hour post-exposure(2-hour pre-exposure, 18 hour post-exposure)
- Forced expired volume in the first second (FEV1) 18 hour post-exposure(immediate post-exposure to ozone within 30 min, 18 hour post-exposure)
- endothelial cell function 1 hour post-exposure(1 hour pre-exposure, 1 hour post-exposure)