Dietary intervention to improve COPD outcomes
Official title: OMEGA - Dietary Intervention - COPD Trial
Run by Johns Hopkins University · NCT05297279 · Data updated 2026-11-12
This study is testing if a home food delivery program that boosts omega-3 fatty acids can help people with COPD breathe better and feel healthier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | March 2027 |
| Study ends | September 2027 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT05297279 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 40 and older with a physician diagnosis of COPD, low omega-3 intake, and living in low-income areas.
✕Probably not a fit
Patients with COPD who have adequate omega-3 intake or do not meet the poverty criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the effects of a home food delivery program designed to increase omega-3 fatty acid intake in individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants will be randomly assigned to receive either the dietary intervention or standard care, with outcomes assessed monthly over a 12-week period. The study aims to determine if dietary modifications can enhance respiratory health and mitigate the negative effects of air pollution on COPD symptoms. Following the intervention, participants will be monitored for an additional three months to evaluate the sustainability of dietary changes.
Why it matters
Potential benefit: If successful, this intervention could lead to improved respiratory health and quality of life for patients with COPD.
How similar studies have gone: Previous studies have indicated that dietary interventions can positively impact health outcomes in chronic diseases, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 40 years, * Physician diagnosis of COPD, * Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume in the First Second (FEV1)/ Forced Vital Capacity (FVC) \<70% and FEV1 (% predicted) \<80%. IF FEV1/FVC \<70% and FEV1 (% predicted) ≥ 80%, additional requirement will be asked: CAT score ≥ 10. Also, IF available for screening purposes: participant can provide a previous pulmonary function testing (PFT) report within the last 6 months. * Tobacco exposure ≥ 10 pack-years, * Poverty criteria as determined by residing in a neighborhood with ≥10% of residents living in poverty, consistent with the definition of poverty area OR not access to private health insurance, OR only completed high school education or less. * Low omega-3 intake (reported daily intake of EPA+DHA intake \<500 mg via diet and/or supplement) at the screening visit, and * Willing to comply with dietary recommendations Exclusion Criteria: * Participant planning to change residence during study period, * Other chronic lung disease, except those with history of asthma if it felt by the investigator not to be a primary diagnosis. * Pregnancy or breastfeeding and * Reported unwillingness to eat seafood.
Where it's running
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Johns Hopkins Bayview Campus
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Nadia Hansel, MD, MPH — Johns Hopkins University
- Study coordinator: Wendy Lorizio, MD, MPH
- Email: wlorizi1@jhmi.edu
- Phone: 410-550-2449
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.