Status:
RECRUITING
OMEGA - Dietary Intervention - COPD Trial
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
COPD, Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
NA
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 (C...
Detailed Description
COPD is a leading cause of death in the US with low-income individuals experiencing increased prevalence and morbidity. Poor dietary intake is also prevalent in low-income communities and has been ass...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05297279
Start Date
March 1 2022
End Date
September 1 2027
Last Update
March 20 2025
Active Locations (1)
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1
Johns Hopkins Bayview Campus
Baltimore, Maryland, United States, 21224