NCT05297279 OMEGA - Dietary Intervention - COPD Trial
| NCT ID | NCT05297279 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | COPD, Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-03-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomized controlled trial of a food delivery dietary intervention targeting increased omega-3 intake to determine whether dietary modifications can improve Chronic Obstructive Pulmonary Disease (COPD) outcomes and attenuate the adverse effects of particulate matter on respiratory health. Investigators believe that study results will comprehensively address the impact of an evidence-based nutrition intervention on COPD health and provide a framework for dietary intervention within other chronic diseases disproportionately impacting susceptible, low-income populations.
Eligibility 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.
Contact & Investigator
Nadia Hansel, MD, MPH
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05297279 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD, Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05297279 currently recruiting?
Yes, NCT05297279 is actively recruiting participants. Contact the research team at wlorizi1@jhmi.edu for enrollment information.
Where is the NCT05297279 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05297279 clinical trial?
NCT05297279 is sponsored by Johns Hopkins University. The principal investigator is Nadia Hansel, MD, MPH at Johns Hopkins University. The trial plans to enroll 200 participants.
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