<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/NCT02251496</url>
  </required_header>
  <id_info>
    <org_study_id>COPD-141316051</org_study_id>
    <nct_id>NCT02251496</nct_id>
  </id_info>
  <brief_title>COPD: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks.</brief_title>
  <acronym>COPD</acronym>
  <official_title>Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks, Weight Changes and Functional Capacity in Chronic Obstructive Pulmonary Disease; Randomized Controlled Dietary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iceland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iceland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At least one fifth of patients in European hospitals are malnourished. Malnutrition is&#xD;
      associated with negative consequences, including higher rates of complications, longer&#xD;
      hospital stay, impaired wound healing and increased mortality with consequent effects on&#xD;
      costs of healthcare. Evidence suggests that there may be benefits to some malnourished&#xD;
      patients from receiving oral nutrition supplements in the short-term but it is not known&#xD;
      whether these benefits can be sustained and indeed whether similar benefits may be achieved&#xD;
      using food-based interventions of lower cost. The overall objective of the study is to&#xD;
      compare two nutritional interventions among malnourished patients with COPD (n=200); oral&#xD;
      nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during&#xD;
      hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is&#xD;
      weight change. Secondary endpoints include forced expiratory volume in one second, forced&#xD;
      vital capacity, six-minute walk distance, hand-grip strength, health related quality of life,&#xD;
      length of hospital stay, energy- and protein intake, readmissions to the hospital and acute&#xD;
      exacerbation. No studies are available comparing the supply of ONS to malnourished patients&#xD;
      with COPD compared with the provision of regular food (in-between meals snacks). The results&#xD;
      of the study will provide important information that might improve nutrition care in the&#xD;
      hospital setting as well as after discharge from the hospital&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with established COPD admitted to the Department of Pulmonary Medicine at&#xD;
      Landspitali National University Hospital from September 2014-September 2016 will be screened&#xD;
      for malnutrition using the NRS2002 screening tool, recommended by ESPEN. Those identified at&#xD;
      risk of malnutrition and are able to give informed consent will be recruited. According to&#xD;
      the Hospital statistics and previous studies on the frequency of malnutrition in this patient&#xD;
      group, the time frame for recruitment is long enough to recruit 200 subjects who will be&#xD;
      randomised into the two study groups (~ 3 subjects per week).&#xD;
&#xD;
      The following baseline data will be collected in order to identify possible confounders. This&#xD;
      will include; socio-demographic data (age, gender, civil status, household size, family and&#xD;
      social network); major medical diagnosis; use of medication; GOLD score (Global Initiative&#xD;
      for Chronic Obstructive Lung Disease), depressive symptoms, cognition), additional discharge&#xD;
      interventions (e.g. outgoing hospital teams, day care with exercise); and use of oral&#xD;
      nutritional supplements.&#xD;
&#xD;
      Inclusion criteria are:&#xD;
&#xD;
        -  Newly admitted patients &gt; 18 years old who were at nutritional risk according to the&#xD;
           validated nutritional risk screening tool (NRS-2002, score 3+)&#xD;
&#xD;
        -  Able to eat orally&#xD;
&#xD;
        -  An anticipated length of hospitalization of &gt; 3 days&#xD;
&#xD;
        -  Sufficient language proficiency&#xD;
&#xD;
      Exclusion criteria are:&#xD;
&#xD;
        -  Dysphagia&#xD;
&#xD;
        -  Food allergy or intolerance&#xD;
&#xD;
        -  Anatomical obstructions preventing oral food intake Exclusion during follow-up: Subjects&#xD;
           who withdraw their consent to participate.&#xD;
&#xD;
      Outcome measures:&#xD;
&#xD;
      The primary endpoint is weight changes up to one year from admission to the hospital.&#xD;
      Secondary endpoints include forced expiratory volume in one second (FEV1), forced vital&#xD;
      capacity (FVC), six-minute walk distance, hand-grip strength, health related quality of life&#xD;
      (HRQoL), length of hospital stay, nutritional status, energy- and protein intake,&#xD;
      readmissions to the hospital in within 30 days, as well as the total number of readmissions&#xD;
      to the hospital and acute exacerbation during follow-up. Functional outcome measurements will&#xD;
      be conducted by trained research assistant in collaboration with the PhD student. Information&#xD;
      about background diets, HRQoL as well as compliance to the intervention diets will be&#xD;
      gathered by the PhD and MS students.&#xD;
&#xD;
      Measurements will be conducted at admission to the hospital (baseline measurements) and&#xD;
      before discharge from the hospital. Clinical examinations at Landspitali National University&#xD;
      Hospital are planned 3, 6 and 12 months after discharge from the hospital. All together we&#xD;
      aim at having five measurement points for each subject. Each examination will take ~ 80&#xD;
      minutes (30 min for the FEV1 and FVC tests, 20 min for the walking test and measurement of&#xD;
      hand-grip strength, and 30 min for the 24-hour recalls and HRQoL questionnaires).&#xD;
      Additionally, the subjects will be contacted on at least two other occasions by phone, in&#xD;
      weeks 2 and 6 (each interview ~20 min).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Changes</measure>
    <time_frame>baseline and one year from admission to the hospital</time_frame>
    <description>Weight changes from baseline and one year from admission to the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life (HRQoL)</measure>
    <time_frame>baseline and one year from admission to the hospital</time_frame>
    <description>Saint George's Respiratory Questionnaire total score (SGRQ) This validated questionnaire is based on 76 items used to calculate three component scores: symptoms, activity and impact, and a total score. A score of 100 represents worst possible health status and a score of 0 represents best possible health status. A change of 4 points in the SGRQ total score is considered the minimum clinically relevant difference.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Oral nutrition supplement (ONS-group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In between meals snacks (Snacks-group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>In between meals snacks (Snacks-group)</intervention_name>
    <description>In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
    <arm_group_label>In between meals snacks (Snacks-group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral nutrition supplement (ONS-group)</intervention_name>
    <description>The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
    <arm_group_label>Oral nutrition supplement (ONS-group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly admitted patients &gt; 18 years old who were at nutritional risk according to the&#xD;
             validated nutritional risk screening tool (NRS-2002, score 3+)&#xD;
&#xD;
          -  Able to eat orally&#xD;
&#xD;
          -  An anticipated length of hospitalization of &gt; 3 days&#xD;
&#xD;
          -  Sufficient language proficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dysphagia&#xD;
&#xD;
          -  Food allergy or intolerance&#xD;
&#xD;
          -  Anatomical obstructions preventing oral food intake&#xD;
&#xD;
        Exclusion during follow-up: Subjects who withdraw their consent to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Áróra R Ingadóttir, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unit for Nutrition Research (UNR)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Department of Thoracic Medicine at Landspítali</name>
      <address>
        <city>Reykjavík</city>
        <zip>101</zip>
        <country>Iceland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iceland</country>
  </location_countries>
  <results_reference>
    <citation>Ingadottir AR, Beck AM, Baldwin C, Weekes CE, Geirsdottir OG, Ramel A, Gislason T, Gunnarsdottir I. Oral nutrition supplements and between-meal snacks for nutrition therapy in patients with COPD identified as at nutritional risk: a randomised feasibility trial. BMJ Open Respir Res. 2019 Jan 3;6(1):e000349. doi: 10.1136/bmjresp-2018-000349. eCollection 2019.</citation>
    <PMID>30687503</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <results_first_submitted>March 26, 2019</results_first_submitted>
  <results_first_submitted_qc>December 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2021</results_first_posted>
  <last_update_submitted>December 23, 2020</last_update_submitted>
  <last_update_submitted_qc>December 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iceland</investigator_affiliation>
    <investigator_full_name>Áróra Rós Ingadóttir</investigator_full_name>
    <investigator_title>Nutritionist M.Sc</investigator_title>
  </responsible_party>
  <keyword>Malnutrition</keyword>
  <keyword>Chronic obstructive pulmonary disease</keyword>
  <keyword>Nutrition Therapy</keyword>
  <keyword>Oral Nutrition Supplement</keyword>
  <keyword>Food</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02251496/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02251496/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oral Nutrition Supplement (ONS-group)</title>
          <description>The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
        </group>
        <group group_id="P2">
          <title>In Between Meals Snacks (Snacks-group)</title>
          <description>In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oral Nutrition Supplement (ONS-group)</title>
          <description>The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
        </group>
        <group group_id="B2">
          <title>In Between Meals Snacks (Snacks-group)</title>
          <description>In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Iceland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" spread="10"/>
                    <measurement group_id="B2" value="49" spread="10"/>
                    <measurement group_id="B3" value="51.4" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.4" spread="4.1"/>
                    <measurement group_id="B2" value="18.0" spread="2.7"/>
                    <measurement group_id="B3" value="18.8" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Weight Changes</title>
        <description>Weight changes from baseline and one year from admission to the hospital</description>
        <time_frame>baseline and one year from admission to the hospital</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Nutrition Supplement (ONS-group)</title>
            <description>The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
          </group>
          <group group_id="O2">
            <title>In Between Meals Snacks (Snacks-group)</title>
            <description>In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Changes</title>
          <description>Weight changes from baseline and one year from admission to the hospital</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="4.6"/>
                    <measurement group_id="O2" value="4.4" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Related Quality of Life (HRQoL)</title>
        <description>Saint George's Respiratory Questionnaire total score (SGRQ) This validated questionnaire is based on 76 items used to calculate three component scores: symptoms, activity and impact, and a total score. A score of 100 represents worst possible health status and a score of 0 represents best possible health status. A change of 4 points in the SGRQ total score is considered the minimum clinically relevant difference.</description>
        <time_frame>baseline and one year from admission to the hospital</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Nutrition Supplement (ONS-group)</title>
            <description>The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
          </group>
          <group group_id="O2">
            <title>In Between Meals Snacks (Snacks-group)</title>
            <description>In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life (HRQoL)</title>
          <description>Saint George's Respiratory Questionnaire total score (SGRQ) This validated questionnaire is based on 76 items used to calculate three component scores: symptoms, activity and impact, and a total score. A score of 100 represents worst possible health status and a score of 0 represents best possible health status. A change of 4 points in the SGRQ total score is considered the minimum clinically relevant difference.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="11.1"/>
                    <measurement group_id="O2" value="8.9" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>The number of participants at risk for Serious Adverse Events and at risk for Other (Not Including Serious) Adverse Events is 34.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oral Nutrition Supplement (ONS-group)</title>
          <description>The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
        </group>
        <group group_id="E2">
          <title>In Between Meals Snacks (Snacks-group)</title>
          <description>In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).&#xD;
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Áróra Rós Ingadóttir</name_or_title>
      <organization>University of Iceland</organization>
      <phone>8461601</phone>
      <email>aroraros@landspitali.is</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02251496
org study id: COPD-141316051
nct id: NCT02251496
lead sponsor: 
has dmc: No
At least one fifth of patients in European hospitals are malnourished. Malnutrition is
      associated with negative consequences, including higher rates of complications, longer
      hospital stay, impaired wound healing and increased mortality with consequent effects on
      costs of healthcare. Evidence suggests that there may be benefits to some malnourished
      patients from receiving oral nutrition supplements in the short-term but it is not known
      whether these benefits can be sustained and indeed whether similar benefits may be achieved
      using food-based interventions of lower cost. The overall objective of the study is to
      compare two nutritional interventions among malnourished patients with COPD (n=200); oral
      nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during
      hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is
      weight change. Secondary endpoints include forced expiratory volume in one second, forced
      vital capacity, six-minute walk distance, hand-grip strength, health related quality of life,
      length of hospital stay, energy- and protein intake, readmissions to the hospital and acute
      exacerbation. No studies are available comparing the supply of ONS to malnourished patients
      with COPD compared with the provision of regular food (in-between meals snacks). The results
      of the study will provide important information that might improve nutrition care in the
      hospital setting as well as after discharge from the hospital
Patients with established COPD admitted to the Department of Pulmonary Medicine at
      Landspitali National University Hospital from September 2014-September 2016 will be screened
      for malnutrition using the NRS2002 screening tool, recommended by ESPEN. Those identified at
      risk of malnutrition and are able to give informed consent will be recruited. According to
      the Hospital statistics and previous studies on the frequency of malnutrition in this patient
      group, the time frame for recruitment is long enough to recruit 200 subjects who will be
      randomised into the two study groups (~ 3 subjects per week).

      The following baseline data will be collected in order to identify possible confounders. This
      will include; socio-demographic data (age, gender, civil status, household size, family and
      social network); major medical diagnosis; use of medication; GOLD score (Global Initiative
      for Chronic Obstructive Lung Disease), depressive symptoms, cognition), additional discharge
      interventions (e.g. outgoing hospital teams, day care with exercise); and use of oral
      nutritional supplements.

      Inclusion criteria are:

        -  Newly admitted patients > 18 years old who were at nutritional risk according to the
           validated nutritional risk screening tool (NRS-2002, score 3+)

        -  Able to eat orally

        -  An anticipated length of hospitalization of > 3 days

        -  Sufficient language proficiency

      Exclusion criteria are:

        -  Dysphagia

        -  Food allergy or intolerance

        -  Anatomical obstructions preventing oral food intake Exclusion during follow-up: Subjects
           who withdraw their consent to participate.

      Outcome measures:

      The primary endpoint is weight changes up to one year from admission to the hospital.
      Secondary endpoints include forced expiratory volume in one second (FEV1), forced vital
      capacity (FVC), six-minute walk distance, hand-grip strength, health related quality of life
      (HRQoL), length of hospital stay, nutritional status, energy- and protein intake,
      readmissions to the hospital in within 30 days, as well as the total number of readmissions
      to the hospital and acute exacerbation during follow-up. Functional outcome measurements will
      be conducted by trained research assistant in collaboration with the PhD student. Information
      about background diets, HRQoL as well as compliance to the intervention diets will be
      gathered by the PhD and MS students.

      Measurements will be conducted at admission to the hospital (baseline measurements) and
      before discharge from the hospital. Clinical examinations at Landspitali National University
      Hospital are planned 3, 6 and 12 months after discharge from the hospital. All together we
      aim at having five measurement points for each subject. Each examination will take ~ 80
      minutes (30 min for the FEV1 and FVC tests, 20 min for the walking test and measurement of
      hand-grip strength, and 30 min for the 24-hour recalls and HRQoL questionnaires).
      Additionally, the subjects will be contacted on at least two other occasions by phone, in
      weeks 2 and 6 (each interview ~20 min).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Weight Changes
time frame: baseline and one year from admission to the hospital
description: Weight changes from baseline and one year from admission to the hospital
measure: Health Related Quality of Life (HRQoL)
time frame: baseline and one year from admission to the hospital
description: Saint George's Respiratory Questionnaire total score (SGRQ) This validated questionnaire is based on 76 items used to calculate three component scores: symptoms, activity and impact, and a total score. A score of 100 represents worst possible health status and a score of 0 represents best possible health status. A change of 4 points in the SGRQ total score is considered the minimum clinically relevant difference.
arm group label: Oral nutrition supplement (ONS-group)
arm group type: Active Comparator
description: The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
arm group label: In between meals snacks (Snacks-group)
arm group type: Active Comparator
description: In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
intervention type: Other
intervention name: In between meals snacks (Snacks-group)
description: In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
arm group label: In between meals snacks (Snacks-group)
intervention type: Other
intervention name: Oral nutrition supplement (ONS-group)
description: The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
arm group label: Oral nutrition supplement (ONS-group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Áróra R Ingadóttir, Master
role: Principal Investigator
affiliation: Unit for Nutrition Research (UNR)
facility: 
country: Iceland
citation: Ingadottir AR, Beck AM, Baldwin C, Weekes CE, Geirsdottir OG, Ramel A, Gislason T, Gunnarsdottir I. Oral nutrition supplements and between-meal snacks for nutrition therapy in patients with COPD identified as at nutritional risk: a randomised feasibility trial. BMJ Open Respir Res. 2019 Jan 3;6(1):e000349. doi: 10.1136/bmjresp-2018-000349. eCollection 2019.
PMID: 30687503
responsible party type: Principal Investigator
investigator affiliation: University of Iceland
investigator full name: Áróra Rós Ingadóttir
investigator title: Nutritionist M.Sc
mesh term: Malnutrition
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 