Health Effects of Ambient Air PollutionPISCESNCT02921048
Effects of Omega-3 Fatty Acids in Ambient Air Pollution Exposure in Healthy Adults
An observational study of Health Effects of Ambient Air Pollution, run by U.S. EPA Human Studies Facility at 1 site in United States.
Trial summary
This observational study recruits healthy individuals who have been routinely taking high amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating the cardiopulmonary effects of exposure to… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Effects of Ambient Air Pollution
- What is being tested?
- omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to 15 Nov 2019
- Phase
- Observational
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy 35-55 year-old male and female subjects
Who may be able to join
- Aged 25-55 years old healthy male and female (19≤BMI≤30).
- Normal resting ECG. No history of heart arrhythmia.
- Oxygen saturation greater than 96% at the time of physical exam.
- Taking at least 3 grams of EPA and DHA from dietary sources including fish oil supplements and ocean fish/shellfish for a 6 months or longer period of time preceding enrollment in the study; or taking no more than 1 serving size (4-6 oz)/month of ocean fish/shellfish, or no more than 1 pill/month of fish oil supplement during the previous 6 months or longer period of time.
Who cannot join
- Individuals with a history of acute or chronic cardiovascular disease, such as myocardial infarction.
- Individuals with a history of chronic respiratory disease, such as COPD and asthma.
- Individuals with a history of cancer (possible exception for history of non-melanoma skin cancer).
- Uncontrolled hypertension (≥150 systolic, ≥90 diastolic).
- Individuals who are diabetic (previously diagnosed or with hemoglobin A1c level >6.4%).
- Individuals who are currently smoking (including vaping, or using hookah or e cigarettes) or have a 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.
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- 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 who do not understand or speak English.
- Individuals who are taking b-blocker medications.
- Individuals who are taking statins.
- Individuals that are unwilling or unable to maintain their current dietary pattern for the whole study.
- Individuals with bleeding or clotting disorders.
- Individuals who have active allergies.
- Individuals who have an allergy to latex, or skin allergy to tape or electrodes.
- Individuals who are pregnant or attempting to become pregnant.
- Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with clinical procedures will be a basis for exclusion.
- Individuals who are currently taking anti-depressants.
- Temporary exclusion criteria:
- Individuals who have had recent (within 6 months) abdominal and/or eye surgery, or been diagnosed with any type of hernia, as well as any other contraindications for raised intra-abdominal pressure.
- Individuals who have had an acute respiratory illness within 4 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
EPA Human Studies Facility
Chapel Hill, North Carolina, 27514
About this study
This observational study recruits healthy individuals who have been routinely taking high amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating the cardiopulmonary effects of exposure to ambient air pollution.
Read the detailed description
Purpose: To examine the relationship between blood levels of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and cardiopulmonary responses to environmental air pollution in healthy adults. EPA and DHA are two important omega-3 fatty acids that are mainly found in seafoods and fish oils and associated with beneficial effects to human physiology.
Participants: Healthy 35-55 year-old male and female subjects will be screened for their dietary intake of EPA and DHA. Qualified volunteers will be divided into two groups, group 1: individuals voluntarily taking at least 3 g/wk of EPA and DHA from dietary sources including fish oil supplements and ocean fish/shellfish consumption for a period of at least 6 months prior to enrollment in the study; group 2: individuals who have consumed no more than 1 serving size (4-6 oz)/month of ocean fish/shellfish, or no more than 1 pill/month of fish oil supplement during the 6 month period preceding enrollment.
Procedures (Methods): In this observational panel study, subjects will come to the U.S. EPA Human Studies Facility for up to 5 sessions, each consisting of 2 consecutive visit days. The following endpoints will be collected: blood pressure, heart rate variability measurements, blood biomarkers, endothelial cell function, retinal venule and arteriole diameter, and lung function. Air pollution exposure will be assessed using area-specific air quality data derived from local air monitoring stations interfaced with activity monitoring and GPS tracked location for each subject.
- Conditions
- Health Effects of Ambient Air Pollution
- Being tested
- omega-3 fatty acids
- Keywords
- Eicosapentaenoic Acid, Docosahexaenoic Acid, Ambient Air Pollution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| omega-3 | individuals voluntarily taking at least 3 g/wk of EPA and DHA from dietary sources including fish oil supplements and ocean fish/shellfish consumption for a period of at least 6 months prior to enrollment in the study Receives: Dietary Supplement: omega-3 fatty acids | |
| control | individuals who have consumed no more than 1 serving size (4-6 oz)/month of ocean fish/shellfish, or no more than 1 pill/month of fish oil supplement during the 6 month period preceding enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability
Measured: Sep. 2016 to Sep 2019
Secondary outcomes (4)
endothelial cell function
Measured: Sep. 2016 to Sep 2019
diameters of retinal arteries and veins
Measured: Sep. 2016 to Sep 2019
pulmonary function indices
Measured: Sep. 2016 to Sep 2019
blood biomarkers
Measured: Sep. 2016 to Sep 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start15 Sep 2016
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health Effects of Ambient Air PollutionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. EPA Human Studies Facility
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Haiyan Tong, U.S. EPA Human Studies Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921048
- Sponsor's protocol ID
- HSF-001
- Acronym
- PISCES
- Status last verified
- May 2022
- First submitted
- 28 Sep 2016
- Last updated
- 10 May 2022
- Results posted
- No
Publications
Chen H, Zhang S, Shen W, Salazar C, Schneider A, Wyatt LH, Rappold AG, Diaz-Sanchez D, Devlin RB, Samet JM, Tong H. Omega-3 fatty acids attenuate cardiovascular effects of short-term exposure to ambient air pollution. Part Fibre Toxicol. 2022 Feb 9;19(1):12. doi: 10.1186/s12989-022-00451-4.
PubMed 35139860Chen H, Zhang S, Shen W, Salazar C, Schneider A, Wyatt L, Rappold AG, Diaz-Sanchez D, Devlin RB, Samet JM, Tong H. The influence of dietary intake of omega-3 polyunsaturated fatty acids on the association between short-term exposure to ambient nitrogen dioxide and respiratory and cardiovascular outcomes among healthy adults. Environ Health. 2021 Dec 7;20(1):123. doi: 10.1186/s12940-021-00809-9.
PubMed 34872587Tong H, Zhang S, Shen W, Chen H, Salazar C, Schneider A, Rappold AG, Diaz-Sanchez D, Devlin RB, Samet JM. Lung Function and Short-Term Ambient Air Pollution Exposure: Differential Impacts of Omega-3 and Omega-6 Fatty Acids. Ann Am Thorac Soc. 2022 Apr;19(4):583-593. doi: 10.1513/AnnalsATS.202107-767OC.
PubMed 34797737
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acids in Ambient Air Pollution Exposure in Healthy Adults
- ClinicalTrials.gov ID
- NCT02921048
- Acronym / sponsor ID
- PISCES / HSF-001
- Conditions
- Health Effects of Ambient Air Pollution
- Keywords
- Eicosapentaenoic Acid, Docosahexaenoic Acid, Ambient Air Pollution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- U.S. EPA Human Studies FacilityUS federal agency
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 30 Sep 2016 (estimated)
- 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.
This observational study recruits healthy individuals who have been routinely taking high amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating the cardiopulmonary effects of exposure to ambient air pollution.
Detailed description
Purpose: To examine the relationship between blood levels of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and cardiopulmonary responses to environmental air pollution in healthy adults. EPA and DHA are two important omega-3 fatty acids that are mainly found in seafoods and fish oils and associated with beneficial effects to human physiology.
Participants: Healthy 35-55 year-old male and female subjects will be screened for their dietary intake of EPA and DHA. Qualified volunteers will be divided into two groups, group 1: individuals voluntarily taking at least 3 g/wk of EPA and DHA from dietary sources including fish oil supplements and ocean fish/shellfish consumption for a period of at least 6 months prior to enrollment in the study; group 2: individuals who have consumed no more than 1 serving size (4-6 oz)/month of ocean fish/shellfish, or no more than 1 pill/month of fish oil supplement during the 6 month period preceding enrollment.
Procedures (Methods): In this observational panel study, subjects will come to the U.S. EPA Human Studies Facility for up to 5 sessions, each consisting of 2 consecutive visit days. The following endpoints will be collected: blood pressure, heart rate variability measurements, blood biomarkers, endothelial cell function, retinal venule and arteriole diameter, and lung function. Air pollution exposure will be assessed using area-specific air quality data derived from local air monitoring stations interfaced with activity monitoring and GPS tracked location for each subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 | – | Dietary Supplement: omega-3 fatty acidsindividuals voluntarily taking at least 3 g/wk of EPA and DHA from dietary sources including fish oil supplements and ocean fish/shellfish consumption for a period of at least 6 months prior to enrollment in the study |
| control | – | –individuals who have consumed no more than 1 serving size (4-6 oz)/month of ocean fish/shellfish, or no more than 1 pill/month of fish oil supplement during the 6 month period preceding enrollment |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy 35-55 year-old male and female subjects
Key inclusion criteria (4 listed)
- Aged 25-55 years old healthy male and female (19≤BMI≤30).
- Normal resting ECG. No history of heart arrhythmia.
- Oxygen saturation greater than 96% at the time of physical exam.
- Taking at least 3 grams of EPA and DHA from dietary sources including fish oil supplements and ocean fish/shellfish for a 6 months or longer period of time preceding enrollment in the study; or taking no more than 1 serving size (4-6 oz)/month of ocean fish/shellfish, or no more than 1 pill/month of fish oil supplement during the previous 6 months or longer period of time.
Key exclusion criteria (21 listed)
- Individuals with a history of acute or chronic cardiovascular disease, such as myocardial infarction.
- Individuals with a history of chronic respiratory disease, such as COPD and asthma.
- Individuals with a history of cancer (possible exception for history of non-melanoma skin cancer).
- Uncontrolled hypertension (≥150 systolic, ≥90 diastolic).
- Individuals who are diabetic (previously diagnosed or with hemoglobin A1c level >6.4%).
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 |
|---|---|---|
| omega-3 fatty acids | Dietary supplement | omega-3 |
Primary outcome
heart rate variability
Time frame: Sep. 2016 to Sep 2019
4 secondary outcomes
endothelial cell function
Time frame: Sep. 2016 to Sep 2019
diameters of retinal arteries and veins
Time frame: Sep. 2016 to Sep 2019
pulmonary function indices
Time frame: Sep. 2016 to Sep 2019
blood biomarkers
Time frame: Sep. 2016 to Sep 2019
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 10 May 2022.
- Derived from this study: PubMed 35139860Chen H, Zhang S, Shen W, Salazar C, Schneider A, Wyatt LH, Rappold AG, Diaz-Sanchez D, Devlin RB, Samet JM, Tong H. Omega-3 fatty acids attenuate cardiovascular effects of short-term exposure to ambient air pollution. Part Fibre Toxicol. 2022 Feb 9;19(1):12. doi: 10.1186/s12989-022-00451-4.
- Derived from this study: PubMed 34872587Chen H, Zhang S, Shen W, Salazar C, Schneider A, Wyatt L, Rappold AG, Diaz-Sanchez D, Devlin RB, Samet JM, Tong H. The influence of dietary intake of omega-3 polyunsaturated fatty acids on the association between short-term exposure to ambient nitrogen dioxide and respiratory and cardiovascular outcomes among healthy adults. Environ Health. 2021 Dec 7;20(1):123. doi: 10.1186/s12940-021-00809-9.
- Derived from this study: PubMed 34797737Tong H, Zhang S, Shen W, Chen H, Salazar C, Schneider A, Rappold AG, Diaz-Sanchez D, Devlin RB, Samet JM. Lung Function and Short-Term Ambient Air Pollution Exposure: Differential Impacts of Omega-3 and Omega-6 Fatty Acids. Ann Am Thorac Soc. 2022 Apr;19(4):583-593. doi: 10.1513/AnnalsATS.202107-767OC.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Effects of Ambient Air Pollution, run by U.S. EPA Human Studies Facility 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 4 inclusion and 21 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 10 May 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
heart rate variability (time frame: Sep. 2016 to Sep 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921048, which also lists 3 linked publications.
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 10 May 2022.