Effects of Omega-3 Fatty Acids in Ambient Air Pollution Exposure in Healthy Adults

NCT02921048 | Completed

• 1 other identifier: HSF-001
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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 ambient air pollution.

Conditions

Health Effects of Ambient Air Pollution

Keywords

Eicosapentaenoic Acid; Docosahexaenoic Acid; Ambient Air Pollution

Outcome Measures

Primary Outcomes (1)

• heart rate variability

  Sep. 2016 to Sep 2019

Secondary Outcomes (4)

• endothelial cell function

  Sep. 2016 to Sep 2019

• diameters of retinal arteries and veins

  Sep. 2016 to Sep 2019

• pulmonary function indices

  Sep. 2016 to Sep 2019

• blood biomarkers

  Sep. 2016 to Sep 2019

Study Arms (2)

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

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

Interventions

omega-3 fatty acids DIETARY_SUPPLEMENT

omega-3

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy 35-55 year-old male and female subjects

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• U.S. EPA Human Studies Facility: lead

Study Sites (1)

EPA Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (3)

• 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.

  PMID: 35139860 DERIVED

• Chen 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.

  PMID: 34872587 DERIVED

• Tong 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.

  PMID: 34797737 DERIVED

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research biologist

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 30, 2016
• Study Start: September 15, 2016
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

US (1)