HealthyPhase 1OMEGOZNCT03395119
Efficacy of Fish Oil or Olive Oil Supplementation on the Health Effects of Ozone Exposure in Healthy Young Subjects
A Phase 1 study testing Ozone, Fish Oil and Olive Oil in people with Healthy and Dietary Supplement, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Dietary Supplement
- What is being tested?
- Ozone, Fish Oil and Olive Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2017to 18 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Environmental Protection Agency Human Studies Facility
Chapel Hill, North Carolina, 27514
About this study
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.
Read the detailed description
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.
Consenting Day We will go over the study in detail so that you will know what we will expect from you as a participant and what you should expect from us as investigators. If you agree to participate in the study, you will sign all study consent forms and receive one set of signed copies.
You will have a breathing test (spirometry). You will breathe through a filter into a plastic device. Your lung function test results should meet certain criteria (Both Forced Vital Capacity (FVC) and Forced Expiatory Volume at the 1st second (FEV1) are equal to and greater than 80% of the reference value) to allow you to participate in the study.
You will undergo a procedure for for induced sputum. If you are a non-producer or the quality of the induced sputum sample that you produce does not meet the study criteria (we will know the sputum quality in the next two days), we will exclude you from the study. If that happens, you will be reimbursed for the time and procedures for the consenting session. If you qualify, you will be given instructions to prepare for the exposure sessions. Then you will be scheduled for the exposure sessions.
You will be give dietary supplementation of fish oil, olive oil or placebo for 4 weeks. Dietary and medication instructions will be given to restrict certain types of food and medicines during the supplementation period.
Exposure days We will call you a few days before the exposure session to remind you of your scheduled visit. You should avoid smoke, fumes, alcohol, and strenuous exercise 24 hours prior to all visits, and abstain from pan fried or grilled meat after midnight of the exposure day.
You will be asked to eat a light breakfast and arrive at the EPA medical station by 7:30 am. Please understand that it is very important that you arrive by this time in order for the study team to process all of the samples and data. Please note that we may have to cancel your participation if you arrive late.
Prior to exposure, you will:
- Have your vital signs checked (heart rate, respiratory rate, blood pressure, oxygen saturation level, and fill out a symptom questionnaire electronically).
- Have your heart rhythm recorded by a Holter monitor. You will have (10) electrocardiogram (ECG) leads attached to your chest. It may be necessary to clean and shave the areas of your chest where these leads will be placed. Excessive deodorant, skin lotions, and body sprays may interfere with the function of some of these leads. Therefore, we ask you to not apply these to your chest area on the day you report to the HSF. The leads will be connected to 2 monitors (small recording devices about the size and weight of a cell phone) to obtain readings of your heart rate and rhythm. It is preferable that the electrodes will stay in place for approximately 2 ½ days as you will have this measured several times during the study, however, you will be given the option to remove the electrodes by the end of each exposure day. You will be asked to recline quietly for 30 minutes while collecting your heart rhythm. It is important that you do not fall asleep during this 30-minute period. These measurements will allow us to determine whether wood smoke exposure causes small changes in the ability of your nervous system to regulate how your heart beats.
- Have the diameter of an artery in your upper arm measured by an ultrasound machine (BAU). The ultrasound operator will scan your arm with a probe and then place a tourniquet on your arm, much like a cuff used to measure blood pressure. Measurement of the size of the artery will be made two times. First, you will be asked to rest quietly for 15 minutes, and then the first 90 second scan will be performed. Then the blood pressure cuff on your arm will be inflated for 5 minutes in order to temporarily stop the flow of blood. You may feel sensations similar to that when your foot "goes to sleep", such as "pins and needles" and tingling. After the pressure cuff is released, a second scan will be taken of the artery.
- Have your retinas imaged using an ophthalmic camera before and after each exposure, and on the follow-up visit. You will be asked to place your chin on a rest in front of the camera. We will take pictures of the inside of both of your eyes. Glasses or contacts have to be removed for this test. Please bring your own contact lens container and solutions.
- Approximately 60 ml blood drawn (about 4 tablespoons) before and after each exposure, and on the follow-up visit. We will test this blood to see if wood smoke affects the ability of your blood cells to function. A small portion of the blood sample will be used to measure the relative content of various fatty acids present in your blood. With your permission, we also store some of the blood that we obtain during the study for yet-to-be-determined tests in the future.
- Have a breathing test (spirometry).
- Enter the exposure chamber and be exposed to filtered air or ozone.
During the exposure, you will:
- Undergo exposure for 2 hours to either clean filtered air or ozone in the chamber. You will receive clean filtered air on one day and ozone on the other day. You will not be given the information of the sequence of the exposure. Chamber conditions will be at a comfortable temperature and relative humidity. You will do mild exercise on a stationary bicycle in the chamber every other 15 minutes alternating with resting period for a total of 1 hour of exercise per chamber exposure. The target ventilation rate will be maintained at 20 L/min/ m2 and monitored by using pneumotach method. A study coordinator or other trained person will be seated outside the chamber observing you at all times. During the exposure, your heart will be monitored and the amount of oxygen present in your blood will be monitored by placing a device (pulse oximeter) on your finger. If it appears you are experiencing significant discomfort, breathing or heart problems, the exposure will be terminated immediately. In addition, you may elect to terminate the exposure at any time for any reason. If you do so, you will be paid in full for that day's session but will be ineligible for further participation in the study and any payments you would have received for future participation.
Immediately following the exposure, you will repeat the pre-exposure procedures and have a low fat lunch brought by you.
- Once you complete the above procedures, you will have about 1-2 hour waiting time before the next procedure. You can bring your personal laptop or books to use during that time. You will not be able to eat any food during this break time.
- Have samples of your airway secretions collected using the induced sputum procedure. You will be asked to breathe in different saline solutions (up to 5%) to help you expectorate. We will coach you on the procedure. First, you will gargle and clear your throat, and the cough up samples from deep in your chest and spit them into a cup. Your lung function will be monitored during the procedure. Food must be avoided for 2 hours prior to this test.
- Be assessed and discharged by the study personnel.
Follow up visit (about 3 hours) You will return to the HSF the next morning (approximately 18 hours after your 2nd exposure) and you will repeat the pre-exposure procedures.
- Conditions
- Healthy, Dietary Supplement
- Being tested
- Ozone, Fish Oil, Olive Oil
- Keywords
- Ozone exposure, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDrug
Also called Filtered air
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/min/m²).
Fish OilDietary supplement
Also called omega-3 fatty acids (eicosapentaenoic/docosahexaenoic)
3 (1-gram) soft-gels daily Commercially available, enteric-coated, soft-gels formulated to deliver >60% eicosapentaenoic/docosahexaenoic acids (EPA/DHA)
Olive OilDietary supplement
Also called extra virgin olive oil
3 soft-gels daily Commercially available soft-gels containing 1 gram of USDA organic certified, cold pressed, extra virgin, olive oil
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ozone |
| 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 Receives: Drug: Ozone; Dietary Supplement: Fish Oil |
| Olive oil | Experimental | 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 Receives: Drug: Ozone; Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expired volume in the first second (FEV1) from air exposure (Day 1) to ozone exposure (Day 2)
FEV1 is determined by spirometry
Measured: Day 1, Day 2
Secondary outcomes (14)
endothelial cell function 1 hour post-exposure
Brachial artery ultrasound will be used to evaluate flow-mediated dilatation which will be performed in the Human Studies Facility (HSF) at U.S. Environmental Protection Agency (EPA) using an ultrasound instrument. The diameter of the brachial artery will be measured at baseline and during reactive hyperemia.
Measured: 1 hour pre-exposure, 1 hour post-exposure
endothelial cell function 18 hour post-exposure
Brachial artery ultrasound will be used to evaluate flow-mediated dilatation which will be performed in the HSF at EPA using an ultrasound instrument. The diameter of the brachial artery will be measured at baseline and during reactive hyperemia.
Measured: 1 hour pre-exposure, 18 hour post-exposure
diameters of retinal arteries and veins 1 hour post-exposure
Retinal images will be taken using an FDA-approved, commercially available, non-mydriatic fundus camera. Images will be taken from both eyes.
Measured: 30 min pre-exposure, 1 hour post-exposure
diameters of retinal arteries and veins 18 hour post-exposure
Retinal images will be taken using an FDA-approved, commercially available, non-mydriatic fundus camera. Images will be taken from both eyes.
Measured: 30 min pre-exposure, 18 hour post-exposure
airway inflammation 4 hour post-exposure
Sputum induction will be performed to determine the airway inflammation.
Measured: 6 weeks prior to the exposure, 4 hour post-exposure
Heart rate variability 1 hour post-exposure
Heart rate variability will be collected by the Holter monitor.
Measured: 1 hour pre-exposure, 1 hour post-exposure
Heart rate variability 18 hour post-exposure
Heart rate variability will be collected by the Holter monitor.
Measured: 1 hour pre-exposure, 18 hour post-exposure
Blood fatty acids 2 hour post-exposure
Blood sample will be collected for fatty acids analysis
Measured: 6 weeks prior to the exposure, 2 hours pre-exposure
Blood fatty acids 30 min post-exposure
Blood sample will be collected for fatty acids analysis
Measured: 2 hour pre-exposure, 30 min post-exposure
Blood fatty acids 18 hour post-exposure
Blood sample will be collected for fatty acids analysis
Measured: 2-hour pre-exposure, 18 hour post-exposure
Blood cholesterol 2 hour post-exposure
Blood sample will be collected for measuring the cholesterol level
Measured: 6 weeks prior to the exposure, 2 hours pre-exposure
Blood cholesterol 30 min post-exposure
Blood sample will be collected for measuring the cholesterol level
Measured: 2 hour pre-exposure, 30 min post-exposure
Blood cholesterol 18 hour post-exposure
Blood sample will be collected for measuring the cholesterol level
Measured: 2-hour pre-exposure, 18 hour post-exposure
Forced expired volume in the first second (FEV1) 18 hour post-exposure
Forced expired volume in the first second (FEV1) is determined by the spirometry
Measured: immediate post-exposure to ozone within 30 min, 18 hour post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start18 Dec 2017
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Environmental Protection Agency (EPA)
- Responsible party
- Sponsor
- Investigators
- James Samet, PhD, Principal investigator, Environmental Protection Agency, University of North Carolina at Chapel Hil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395119
- Sponsor's protocol ID
- 15-2960
- Acronym
- OMEGOZ
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data will be shared through the U.S. EPA's ScienceHub database. ScienceHub is used to upload and store datasets associated with journal articles. Non-sensitive datasets are then made publicly accessible via the Environmental Dataset Gateway in fulfillment of the EPA's requirement to adhere to the Office of Management and Budget's Open Data Policy.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fish Oil or Olive Oil Supplementation on the Health Effects of Ozone Exposure in Healthy Young Subjects
- ClinicalTrials.gov ID
- NCT03395119
- Acronym / sponsor ID
- OMEGOZ / 15-2960
- Conditions
- Healthy, Dietary Supplement
- Keywords
- Ozone exposure, Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Environmental Protection Agency (EPA)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Consenting Day We will go over the study in detail so that you will know what we will expect from you as a participant and what you should expect from us as investigators. If you agree to participate in the study, you will sign all study consent forms and receive one set of signed copies.
You will have a breathing test (spirometry). You will breathe through a filter into a plastic device. Your lung function test results should meet certain criteria (Both Forced Vital Capacity (FVC) and Forced Expiatory Volume at the 1st second (FEV1) are equal to and greater than 80% of the reference value) to allow you to participate in the study.
You will undergo a procedure for for induced sputum. If you are a non-producer or the quality of the induced sputum sample that you produce does not meet the study criteria (we will know the sputum quality in the next two days), we will exclude you from the study. If that happens, you will be reimbursed for the time and procedures for the consenting session. If you qualify, you will be given instructions to prepare for the exposure sessions. Then you will be scheduled for the exposure sessions.
You will be give dietary supplementation of fish oil, olive oil or placebo for 4 weeks. Dietary and medication instructions will be given to restrict certain types of food and medicines during the supplementation period.
Exposure days We will call you a few days before the exposure session to remind you of your scheduled visit. You should avoid smoke, fumes, alcohol, and strenuous exercise 24 hours prior to all visits, and abstain from pan fried or grilled meat after midnight of the exposure day.
You will be asked to eat a light breakfast and arrive at the EPA medical station by 7:30 am. Please understand that it is very important that you arrive by this time in order for the study team to process all of the samples and data. Please note that we may have to cancel your participation if you arrive late.
Prior to exposure, you will:
- Have your vital signs checked (heart rate, respiratory rate, blood pressure, oxygen saturation level, and fill out a symptom questionnaire electronically).
- Have your heart rhythm recorded by a Holter monitor. You will have (10) electrocardiogram (ECG) leads attached to your chest. It may be necessary to clean and shave the areas of your chest where these leads will be placed. Excessive deodorant, skin lotions, and body sprays may interfere with the function of some of these leads. Therefore, we ask you to not apply these to your chest area on the day you report to the HSF. The leads will be connected to 2 monitors (small recording devices about the size and weight of a cell phone) to obtain readings of your heart rate and rhythm. It is preferable that the electrodes will stay in place for approximately 2 ½ days as you will have this measured several times during the study, however, you will be given the option to remove the electrodes by the end of each exposure day. You will be asked to recline quietly for 30 minutes while collecting your heart rhythm. It is important that you do not fall asleep during this 30-minute period. These measurements will allow us to determine whether wood smoke exposure causes small changes in the ability of your nervous system to regulate how your heart beats.
- Have the diameter of an artery in your upper arm measured by an ultrasound machine (BAU). The ultrasound operator will scan your arm with a probe and then place a tourniquet on your arm, much like a cuff used to measure blood pressure. Measurement of the size of the artery will be made two times. First, you will be asked to rest quietly for 15 minutes, and then the first 90 second scan will be performed. Then the blood pressure cuff on your arm will be inflated for 5 minutes in order to temporarily stop the flow of blood. You may feel sensations similar to that when your foot "goes to sleep", such as "pins and needles" and tingling. After the pressure cuff is released, a second scan will be taken of the artery.
- Have your retinas imaged using an ophthalmic camera before and after each exposure, and on the follow-up visit. You will be asked to place your chin on a rest in front of the camera. We will take pictures of the inside of both of your eyes. Glasses or contacts have to be removed for this test. Please bring your own contact lens container and solutions.
- Approximately 60 ml blood drawn (about 4 tablespoons) before and after each exposure, and on the follow-up visit. We will test this blood to see if wood smoke affects the ability of your blood cells to function. A small portion of the blood sample will be used to measure the relative content of various fatty acids present in your blood. With your permission, we also store some of the blood that we obtain during the study for yet-to-be-determined tests in the future.
- Have a breathing test (spirometry).
- Enter the exposure chamber and be exposed to filtered air or ozone.
During the exposure, you will:
- Undergo exposure for 2 hours to either clean filtered air or ozone in the chamber. You will receive clean filtered air on one day and ozone on the other day. You will not be given the information of the sequence of the exposure. Chamber conditions will be at a comfortable temperature and relative humidity. You will do mild exercise on a stationary bicycle in the chamber every other 15 minutes alternating with resting period for a total of 1 hour of exercise per chamber exposure. The target ventilation rate will be maintained at 20 L/min/ m2 and monitored by using pneumotach method. A study coordinator or other trained person will be seated outside the chamber observing you at all times. During the exposure, your heart will be monitored and the amount of oxygen present in your blood will be monitored by placing a device (pulse oximeter) on your finger. If it appears you are experiencing significant discomfort, breathing or heart problems, the exposure will be terminated immediately. In addition, you may elect to terminate the exposure at any time for any reason. If you do so, you will be paid in full for that day's session but will be ineligible for further participation in the study and any payments you would have received for future participation.
Immediately following the exposure, you will repeat the pre-exposure procedures and have a low fat lunch brought by you.
- Once you complete the above procedures, you will have about 1-2 hour waiting time before the next procedure. You can bring your personal laptop or books to use during that time. You will not be able to eat any food during this break time.
- Have samples of your airway secretions collected using the induced sputum procedure. You will be asked to breathe in different saline solutions (up to 5%) to help you expectorate. We will coach you on the procedure. First, you will gargle and clear your throat, and the cough up samples from deep in your chest and spit them into a cup. Your lung function will be monitored during the procedure. Food must be avoided for 2 hours prior to this test.
- Be assessed and discharged by the study personnel.
Follow up visit (about 3 hours) You will return to the HSF the next morning (approximately 18 hours after your 2nd exposure) and you will repeat the pre-exposure procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Supplements | Sham comparator | Drug: OzoneThe 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 |
| Fish oil | Experimental | Drug: Ozone, Dietary Supplement: Fish OilTwenty 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 |
| Olive oil | Experimental | Drug: Ozone, Dietary Supplement: Olive OilTwenty 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzoneAlso: Filtered airAfter 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/min/m²). | Drug | Fish oil, No Supplements, Olive oil |
| Fish OilAlso: omega-3 fatty acids (eicosapentaenoic/docosahexaenoic)3 (1-gram) soft-gels daily Commercially available, enteric-coated, soft-gels formulated to deliver >60% eicosapentaenoic/docosahexaenoic acids (EPA/DHA) | Dietary supplement | Fish oil |
| Olive OilAlso: extra virgin olive oil3 soft-gels daily Commercially available soft-gels containing 1 gram of USDA organic certified, cold pressed, extra virgin, olive oil | Dietary supplement | Olive oil |
Primary outcome
Change in forced expired volume in the first second (FEV1) from air exposure (Day 1) to ozone exposure (Day 2)
Time frame: Day 1, Day 2
FEV1 is determined by spirometry
14 secondary outcomes
endothelial cell function 1 hour post-exposure
Time frame: 1 hour pre-exposure, 1 hour post-exposure
endothelial cell function 18 hour post-exposure
Time frame: 1 hour pre-exposure, 18 hour post-exposure
diameters of retinal arteries and veins 1 hour post-exposure
Time frame: 30 min pre-exposure, 1 hour post-exposure
diameters of retinal arteries and veins 18 hour post-exposure
Time frame: 30 min pre-exposure, 18 hour post-exposure
airway inflammation 4 hour post-exposure
Time frame: 6 weeks prior to the exposure, 4 hour post-exposure
Heart rate variability 1 hour post-exposure
Time frame: 1 hour pre-exposure, 1 hour post-exposure
Heart rate variability 18 hour post-exposure
Time frame: 1 hour pre-exposure, 18 hour post-exposure
Blood fatty acids 2 hour post-exposure
Time frame: 6 weeks prior to the exposure, 2 hours pre-exposure
Blood fatty acids 30 min post-exposure
Time frame: 2 hour pre-exposure, 30 min post-exposure
Blood fatty acids 18 hour post-exposure
Time frame: 2-hour pre-exposure, 18 hour post-exposure
Blood cholesterol 2 hour post-exposure
Time frame: 6 weeks prior to the exposure, 2 hours pre-exposure
Blood cholesterol 30 min post-exposure
Time frame: 2 hour pre-exposure, 30 min post-exposure
Blood cholesterol 18 hour post-exposure
Time frame: 2-hour pre-exposure, 18 hour post-exposure
Forced expired volume in the first second (FEV1) 18 hour post-exposure
Time frame: immediate post-exposure to ozone within 30 min, 18 hour post-exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: Yes. Deidentified individual data will be shared through the U.S. EPA's ScienceHub database. ScienceHub is used to upload and store datasets associated with journal articles. Non-sensitive datasets are then made publicly accessible via the Environmental Dataset Gateway in fulfillment of the EPA's requirement to adhere to the Office of Management and Budget's Open Data Policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Samet, PhD principal investigator
Environmental Protection Agency, University of North Carolina at Chapel Hil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ozone, Fish Oil and Olive Oil in people with Healthy and Dietary Supplement, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forced expired volume in the first second (FEV1) from air exposure (Day 1) to ozone exposure (Day 2) (time frame: Day 1, Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.