Dietary intervention to improve COPD outcomes
OMEGA - Dietary Intervention - COPD Trial
NA · Johns Hopkins University · NCT05297279
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05297279 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have indicated that dietary interventions can positively impact health outcomes in chronic diseases, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COPD, Chronic Obstructive Pulmonary Disease