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Completed

NCT Number: NCT03806868

Dietary Intervention Increasing Omega-3 Intake

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).

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

A voucher will be provided weekly (4 times) for ordering only omega-3 rich foods. Groceries will be delivered to participants' home weekly.

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

Other

A voucher will be provided weekly (4 times) for ordering any type of food. Groceries will be delivered to participants' home weekly.

Primary outcomes

  1. Change in serum omega 3 levels

    Time frame: Baseline, 2 weeks and 4 weeks

    Omega 3 levels in serum (mg) will be measured at each study visit.

  2. Change in omega 3 intake

    Time frame: 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

Secondary outcomes

  1. Change in health status as assessed by the Clinical COPD Questionnaire (CCQ)

    Time frame: 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.

  2. Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score

    Time frame: 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.

  3. Change in Functional status (CAT)

    Time frame: 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

  4. Change in FEV1 percentage predicted

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Dietary Intervention Increasing Omega-3 Intake- Feasibility Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2019
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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