<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03806868</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00069904</org_study_id>
    <secondary_id>P50MD010431</secondary_id>
    <nct_id>NCT03806868</nct_id>
  </id_info>
  <brief_title>Dietary Intervention Increasing Omega-3 Intake</brief_title>
  <official_title>Dietary Intervention Increasing Omega-3 Intake- Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Dietary Intervention is being done to evaluate the feasibility of a food voucher program&#xD;
      and dietary counseling to increase consumption of healthy fatty acids (omega-3) in&#xD;
      individuals with Chronic Obstructive Pulmonary Disease (COPD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this pilot intervention is to evaluate the feasibility of a food voucher program&#xD;
      and dietary counseling to increase dietary intake of omega-3 fatty acid in individuals with&#xD;
      COPD.&#xD;
&#xD;
      This hypothesis is based on a number of recent observations. Studies have investigated the&#xD;
      impact of omega-3 fatty acids, especially Eicosapentaenoic acid (EPA), Docosahexaenoic acid&#xD;
      (DHA), alfa-linolenic acid (ALA) intake in chronic diseases and show a link with decreased&#xD;
      systemic inflammation measured by cytokines including interleukin 1 (IL-1B), interleukin 6&#xD;
      (IL-6), interleukin 10 (IL-10), tumoral necrosis factor alfa (TNF-α) and eicosanoids; and&#xD;
      improved outcomes. In a large cross-sectional study of individuals with COPD, a diet rich in&#xD;
      the omega-3 ALA was associated with lower serum TNF-α levels while a diet rich in the&#xD;
      omega-6's LA and arachidonic acid (AA) had higher systemic inflammatory markers IL-6 and&#xD;
      c-reactive protein (CRP). Other recent nutritional epidemiological study showed the&#xD;
      association of greater intakes of omega-3 fatty acids with better lung function profile, but&#xD;
      also a slower forced expiratory volume at the 1 second (FEV1) decline in the same smoker&#xD;
      cohort.&#xD;
&#xD;
      Preliminary cross-sectional data (n=59), from the CLEAN Air study, reported that at baseline,&#xD;
      a higher omega 3 dietary intake was linked with reduced systemic inflammation (IL-1B) and&#xD;
      improved respiratory outcomes (a 28% decrease in the odds of COPD symptoms in moderate-severe&#xD;
      COPD and conversely, higher omega-6 levels associated with worse outcomes, including&#xD;
      increased dyspnea and lower lung function. These findings support the importance of&#xD;
      implementing an intervention program to confirm there is a beneficial association between&#xD;
      fatty acid dietary intake and reduced COPD symptoms.&#xD;
&#xD;
      To this end, the investigators propose a pilot intervention study in 20 subjects to see if&#xD;
      the investigators can increase omega-3 dietary intake over a 4 week period. The investigators&#xD;
      will measure self-report dietary intake of omega 3 and 6 fatty acids, as well as measure,&#xD;
      fasting plasma fatty acid levels, before and after the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">February 21, 2020</completion_date>
  <primary_completion_date type="Actual">February 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum omega 3 levels</measure>
    <time_frame>Baseline, 2 weeks and 4 weeks</time_frame>
    <description>Omega 3 levels in serum (mg) will be measured at each study visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in omega 3 intake</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in health status as assessed by the Clinical COPD Questionnaire (CCQ)</measure>
    <time_frame>Baseline, 2 weeks and 4 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score</measure>
    <time_frame>Baseline, 2 weeks and 4 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional status (CAT)</measure>
    <time_frame>Baseline, 2 weeks and 4 weeks</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1 percentage predicted</measure>
    <time_frame>Baseline, 2 weeks and 4 weeks</time_frame>
    <description>Pulmonary function testing will be assessed as FEV1 percentage predicted, that is FEV1, adjusted for age, height, race and sex.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>voucher for ordering foods (ONLY omega-3 rich foods)</intervention_name>
    <description>A voucher will be provided weekly (4 times) for ordering only omega-3 rich foods. Groceries will be delivered to participants' home weekly.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>voucher for ordering foods in general (any type of foods)</intervention_name>
    <description>A voucher will be provided weekly (4 times) for ordering any type of food. Groceries will be delivered to participants' home weekly.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 40 years,&#xD;
&#xD;
          -  Physician diagnosis of COPD, Global Initiative for Obstructive Lung Disease (GOLD)&#xD;
             Stage II-IV disease with Forced -Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC)&#xD;
             &lt;70% and FEV1 (% predicted) &lt;80%,&#xD;
&#xD;
          -  Tobacco exposure ≥ 10 pack-years&#xD;
&#xD;
          -  Former smoker with an exhaled Carbon Monoxide (eCO)&lt;=6 ppm to confirm smoking status&#xD;
&#xD;
          -  No home smoking ban.&#xD;
&#xD;
          -  Subjects with low omega-3 intake (EPA+DHA levels &lt;500mg) based on data extracted from&#xD;
             a food frequency questionnaire (FFQ) completed before the randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic systemic corticosteroids,&#xD;
&#xD;
          -  Other chronic lung disease including asthma,&#xD;
&#xD;
          -  Living in location other than home (e.g., long term care facility)&#xD;
&#xD;
          -  Homeowner or occupant planning to move or change residence within study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>NADIA NATHALIE HANSEL</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Campus</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03806868
org study id: IRB00069904
secondary id: P50MD010431
nct id: NCT03806868
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Change in serum omega 3 levels
time frame: Baseline, 2 weeks and 4 weeks
description: Omega 3 levels in serum (mg) will be measured at each study visit.
measure: Change in omega 3 intake
time frame: Baseline and 4 weeks
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
measure: Change in health status as assessed by the Clinical COPD Questionnaire (CCQ)
time frame: Baseline, 2 weeks and 4 weeks
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.
measure: Change in the Cough and Sputum Assessment Questionnaire (CASA-Q) Score
time frame: Baseline, 2 weeks and 4 weeks
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.
measure: Change in Functional status (CAT)
time frame: Baseline, 2 weeks and 4 weeks
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
measure: Change in FEV1 percentage predicted
time frame: Baseline, 2 weeks and 4 weeks
description: Pulmonary function testing will be assessed as FEV1 percentage predicted, that is FEV1, adjusted for age, height, race and sex.
arm group label: Intervention group
arm group type: Active Comparator
description: The Intervention group will receive a voucher for ordering foods (ONLY omega-3 rich foods) weekly (4 times).
arm group label: Control group
arm group type: Sham Comparator
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: voucher for ordering foods (ONLY omega-3 rich foods)
description: A voucher will be provided weekly (4 times) for ordering only omega-3 rich foods. Groceries will be delivered to participants' home weekly.
arm group label: Intervention group
intervention type: Other
intervention name: voucher for ordering foods in general (any type of foods)
description: A voucher will be provided weekly (4 times) for ordering any type of food. Groceries will be delivered to participants' home weekly.
arm group label: Control group
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: NADIA NATHALIE HANSEL
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No