Thinking of joining a study?

Register your interest

NCT03806868 | Completed | Chronic Obstructive Pulmonary Disease

Dietary Intervention Increasing Omega-3 Intake

Johns Hopkins University

Brief Summary:

This Dietary Intervention is being done to evaluate the feasibility of a food voucher program and dietary counseling to increase consumption of healthy fatty acids (omega-3) in individuals with Chronic Obstructive Pulmonary Disease (COPD).

Condition or disease

Chronic Obstructive Pulmonary Disease


voucher for ordering foods (ONLY omega-3 rich foods)

voucher for ordering foods in general (any type of foods)


Not Applicable

Detailed Description:

The goal of this pilot intervention is to evaluate the feasibility of a food voucher program and dietary counseling to increase dietary intake of omega-3 fatty acid in individuals with COPD. This hypothesis is based on a number of recent observations. Studies have investigated the impact of omega-3 fatty acids, especially Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), alfa-linolenic acid (ALA) intake in chronic diseases and show a link with decreased systemic inflammation measured by cytokines including interleukin 1 (IL-1B), interleukin 6 (IL-6), interleukin 10 (IL-10), tumoral necrosis factor alfa (TNF-α) and eicosanoids; and improved outcomes. In a large cross-sectional study of individuals with COPD, a diet rich in the omega-3 ALA was associated with lower serum TNF-α levels while a diet rich in the omega-6's LA and arachidonic acid (AA) had higher systemic inflammatory markers IL-6 and c-reactive protein (CRP). Other recent nutritional epidemiological study showed the association of greater intakes of omega-3 fatty acids with better lung function profile, but also a slower forced expiratory volume at the 1 second (FEV1) decline in the same smoker cohort. Preliminary cross-sectional data (n=59), from the CLEAN Air study, reported that at baseline, a higher omega 3 dietary intake was linked with reduced systemic inflammation (IL-1B) and improved respiratory outcomes (a 28% decrease in the odds of COPD symptoms in moderate-severe COPD and conversely, higher omega-6 levels associated with worse outcomes, including increased dyspnea and lower lung function. These findings support the importance of implementing an intervention program to confirm there is a beneficial association between fatty acid dietary intake and reduced COPD symptoms. To this end, the investigators propose a pilot intervention study in 20 subjects to see if the investigators can increase omega-3 dietary intake over a 4 week period. The investigators will measure self-report dietary intake of omega 3 and 6 fatty acids, as well as measure, fasting plasma fatty acid levels, before and after the intervention.

Study Type : Interventional
Estimated Enrollment : 20 participants
Masking: Double
Primary Purpose: Other
Official Title: Dietary Intervention Increasing Omega-3 Intake- Feasibility Trial
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : February 14, 2020
Estimated Study Completion Date : February 21, 2020
Arm Intervention/treatment

Active Comparator: Intervention group

The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times).

Other: voucher for ordering foods (ONLY omega-3 rich foods)

Sham Comparator: Control group

The Control group will receive a voucher for ordering foods in general (any type of foods) weekly (4 times). Participants will NOT be limited to purchasing foods rich in omega-3.

Other: voucher for ordering foods in general (any type of foods)

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria
  • Age ≥ 40 years,
  • Physician diagnosis of COPD, Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced -Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) <70% and FEV1 (% predicted) <80%,
  • Tobacco exposure ≥ 10 pack-years
  • Former smoker with an exhaled Carbon Monoxide (eCO)<=6 ppm to confirm smoking status
  • No home smoking ban.
  • Subjects with low omega-3 intake (EPA+DHA levels <500mg) based on data extracted from a food frequency questionnaire (FFQ) completed before the randomization.
Exclusion Criteria
  • Chronic systemic corticosteroids,
  • Other chronic lung disease including asthma,
  • Living in location other than home (e.g., long term care facility)
  • Homeowner or occupant planning to move or change residence within study period.

Dietary Intervention Increasing Omega-3 Intake

Location Details

Please Choose a site

Dietary Intervention Increasing Omega-3 Intake

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.


Not yet recruiting

United States, Maryland

Johns Hopkins Bayview Campus

Baltimore, Maryland, United States, 21224