Dietary Intervention Increasing Omega-3 Intake

• ClinicalTrials.gov Identifier: NCT03806868
• Recruitment Status: Completed
• First Posted: January 16, 2019
• Last Update Posted: March 4, 2020
• Sponsor: Johns Hopkins University
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: voucher for ordering foods (ONLY omega-3 rich foods); Other: 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Dietary Intervention Increasing Omega-3 Intake- Feasibility Trial
• Actual Study Start Date: January 23, 2019
• Actual Primary Completion Date: February 14, 2020
• Actual Study Completion Date: February 21, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Bayview Campus

Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: NADIA NATHALIE HANSEL; Johns Hopkins University

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03806868
• Other Study ID Numbers: IRB00069904; P50MD010431 ( U.S. NIH Grant/Contract )
• First Posted: January 16, 2019
• Last Update Posted: March 4, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:

COPD

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases