search
Back to results

Dietary Intervention Increasing Omega-3 Intake

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
voucher for ordering foods (ONLY omega-3 rich foods)
voucher for ordering foods in general (any type of foods)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Intervention group

Control group

Arm Description

The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times).

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.

Outcomes

Primary Outcome Measures

Change in serum omega 3 levels
Omega 3 levels in serum (mg) will be measured at each study visit.
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

Secondary Outcome Measures

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.
Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score
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)
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
Pulmonary function testing will be assessed as FEV1 percentage predicted, that is FEV1, adjusted for age, height, race and sex.

Full Information

First Posted
January 14, 2019
Last Updated
March 2, 2020
Sponsor
Johns Hopkins University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03806868
Brief Title
Dietary Intervention Increasing Omega-3 Intake
Official Title
Dietary Intervention Increasing Omega-3 Intake- Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times).
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
voucher for ordering foods (ONLY omega-3 rich foods)
Intervention Description
A voucher will be provided weekly (4 times) for ordering only omega-3 rich foods. Groceries will be delivered to participants' home weekly.
Intervention Type
Other
Intervention Name(s)
voucher for ordering foods in general (any type of foods)
Intervention Description
A voucher will be provided weekly (4 times) for ordering any type of food. Groceries will be delivered to participants' home weekly.
Primary Outcome Measure Information:
Title
Change in serum omega 3 levels
Description
Omega 3 levels in serum (mg) will be measured at each study visit.
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in omega 3 intake
Description
A food frequency questionnaire will be administered at baseline and 4 weeks after randomization to estimate omega 3 intake (mg) at each study visit
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in health status as assessed by the Clinical COPD Questionnaire (CCQ)
Description
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.
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score
Description
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.
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in Functional status (CAT)
Description
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
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in FEV1 percentage predicted
Description
Pulmonary function testing will be assessed as FEV1 percentage predicted, that is FEV1, adjusted for age, height, race and sex.
Time Frame
Baseline, 2 weeks and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NADIA NATHALIE HANSEL
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dietary Intervention Increasing Omega-3 Intake

We'll reach out to this number within 24 hrs