Thinking of joining a study?

Register your interest

NCT03806868 | Completed | Chronic Obstructive Pulmonary Disease


Dietary Intervention Increasing Omega-3 Intake
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).

Condition or disease

Chronic Obstructive Pulmonary Disease

Intervention/treatment

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

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

Phase

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 Type : Interventional
Estimated Enrollment : 20 participants
Masking : Double
Primary Purpose : Other
Official Title : Dietary Intervention Increasing Omega-3 Intake- Feasibility Trial
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : February 14, 2020
Estimated Study Completion Date : February 21, 2020
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)

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)

Ages Eligible for Study: 40 Years
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.

Dietary Intervention Increasing Omega-3 Intake

Location Details


Please Choose a site



Dietary Intervention Increasing Omega-3 Intake

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Maryland

Johns Hopkins Bayview Campus

Baltimore, Maryland, United States, 21224

Loading...