Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50MD010431 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times). |
|
| Control group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum omega 3 levels | Omega 3 levels in serum (mg) will be measured at each study visit. | Baseline, 2 weeks and 4 weeks |
| Change in omega 3 intake | A food frequency questionnaire will be administered at baseline and 4 weeks after randomization to estimate omega 3 intake (mg) at each study visit | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health status as assessed by the Clinical COPD Questionnaire (CCQ) | 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. | Baseline, 2 weeks and 4 weeks |
| Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| NADIA NATHALIE HANSEL | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Campus | Baltimore | Maryland | 21224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
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. |
| Baseline, 2 weeks and 4 weeks |
| Change in Functional status (CAT) | 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 | Baseline, 2 weeks and 4 weeks |
| Change in FEV1 percentage predicted | Pulmonary function testing will be assessed as FEV1 percentage predicted, that is FEV1, adjusted for age, height, race and sex. | Baseline, 2 weeks and 4 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |