Dietary Intervention Increasing Omega-3 Intake



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:2/24/2019
Start Date:January 23, 2019
End Date:December 2019
Contact:Karina Romero
Email:kromero4@jhmi.edu
Phone:4105502602

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Dietary Intervention Increasing Omega-3 Intake- Feasibility Trial

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.

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.
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: NADIA NATHALIE HANSEL
Phone: 443-630-9527
?
mi
from
Baltimore, MD
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