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OMEGA - Dietary Intervention - COPD Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be part of this study for 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether delivered food that adds more omega-3 fats to the diet can improve COPD, a long-term lung disease that makes breathing hard. It also tests whether these diet changes can reduce harm from tiny particles in the air. The study is for adults age 40 or older with COPD who eat little omega-3 and meet certain income, insurance, or education rules.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 40 or older.
  • A doctor has diagnosed you with COPD.
  • Your breathing tests meet these limits: FEV1/FVC below 70% and FEV1 below 80% of the expected value. These measure how much air you can blow out and how fast. If FEV1 is 80% or higher, you must also score at least 10 on the COPD Assessment Test (CAT), which checks symptoms.
  • If available, you can provide a breathing test report from the past 6 months for screening.
  • You have smoked at least 10 pack-years, such as 1 pack a day for 10 years.
  • You meet at least one of these rules: live in an area where at least 10% of people live in poverty, have no access to private health insurance, or have a high school education or less.
  • At screening, you report getting less than 500 mg a day of EPA and DHA, two omega-3 fats, from food and supplements combined.
  • You are willing to follow the study's diet advice.

Who can't join

  • You plan to move during the study.
  • You have another long-term lung disease. A history of asthma may be allowed if the study doctor decides it is not your main diagnosis.
  • You are pregnant or breastfeeding.
  • You are not willing to eat seafood.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD