Dietary Intervention Increasing Omega-3 Intake

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: voucher for ordering foods in general (any type of foods); Other: voucher for ordering foods (ONLY omega-3 rich foods)

• Registration Number: NCT03806868
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Study Start: 2019-01-23
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	voucher for ordering foods in general (any type of foods)	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.
Intervention group	voucher for ordering foods (ONLY omega-3 rich foods)	The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times).

Primary Outcome Measures

Name	Time	Method
Change in omega 3 intake	Baseline and 4 weeks	A food frequency questionnaire will be administered at baseline and 4 weeks after randomization to estimate omega 3 intake (mg) at each study visit
Change in serum omega 3 levels	Baseline, 2 weeks and 4 weeks	Omega 3 levels in serum (mg) will be measured at each study visit.

Secondary Outcome Measures

Name	Time	Method
Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score	Baseline, 2 weeks and 4 weeks	The CASA-Q will be administered at each study visit. Total score ranges from 0 to 100, with higher scores associated with fewer symptoms/less impact due to cough or sputum.
Change in health status as assessed by the Clinical COPD Questionnaire (CCQ)	Baseline, 2 weeks and 4 weeks	The CCQ is a validated score to assess health status in COPD subjects. Score ranges from 0 to 6. The higher the score indicates lower health status.
Change in Functional status (CAT)	Baseline, 2 weeks and 4 weeks	Functional status will be assessed with the COPD assessment test (CAT). The total score is from 0 to 40. Higher scores indicate worse COPD control
Change in FEV1 percentage predicted	Baseline, 2 weeks and 4 weeks	Pulmonary function testing will be assessed as FEV1 percentage predicted, that is FEV1, adjusted for age, height, race and sex.

Trial Locations

Locations (1)

Johns Hopkins Bayview Campus; 🇺🇸 Baltimore, Maryland, United States