Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
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.
Interventions
OTHERvoucher for ordering foods (ONLY omega-3 rich foods)
A voucher will be provided weekly (4 times) for ordering only omega-3 rich foods. Groceries will be delivered to participants' home weekly.
OTHERvoucher for ordering foods in general (any type of foods)
A voucher will be provided weekly (4 times) for ordering any type of food. Groceries will be delivered to participants' home weekly.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
United States
Outcome results
None listed