<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/NCT02197871</url>
  </required_header>
  <id_info>
    <org_study_id>CX20140718</org_study_id>
    <nct_id>NCT02197871</nct_id>
  </id_info>
  <brief_title>Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD</brief_title>
  <official_title>Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD:a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangzhou Institute of Respiratory Disease</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhujiang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insufficient energy intake and systematic inflammation lead to malnutrition in patients with&#xD;
      chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the&#xD;
      patients'nutritional status by increasing energy intake and providing anti-inflammatory&#xD;
      elements，which can relieve the patients' symptoms and delay the disease progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malnutrition is very common in patients with COPD. The main reasons include short intake of&#xD;
      energy and systematic inflammation. In our randomized and controlled clinical trial, patients&#xD;
      will be divided into two groups: the experimental group and the control group. Patients in&#xD;
      the experimental group will be provided nutritional supplements in addition to usual diet&#xD;
      every day for three months and patients in the controlled group with usual diet. According to&#xD;
      the changes of patients' body composition, anthropometrics, inflammatory markers, lung&#xD;
      function, respiratory muscle function, exercise capacity, degree of dyspnea and health&#xD;
      related quality of life(HRQL) after intervention，the nutritional status and inflammation&#xD;
      status are assessed, which contributes to the prediction of prognosis. The nutritional&#xD;
      supplements is a kind of oral liquid composed of proteins, omega-3 fatty acids, carbohydrate,&#xD;
      vitamins, which provides about 260 kcal energy per 200ml. The patients from the&#xD;
      interventional group need drink the nutritional supplements according to the estimated energy&#xD;
      intake and a record should be made everyday. The patients will be followed up regularly by&#xD;
      the researcher.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in nutritional status</measure>
    <time_frame>Before and three months after nutrition supplementation</time_frame>
    <description>Differences in weight,muscle mass(MM),fat mass(FM),free fat mass(FFM),protein，body mass index(BMI),free fat mass index(FFMI) evaluated by bio-impedance measuring technology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the serum levels of inflammatory markers</measure>
    <time_frame>Before and three months after nutrition supplementation</time_frame>
    <description>Changes in the serum levels of tumor necrosis factor-α(TNF-α)、interleukin-6（IL-6）、C-reactive protein(CRP) by laboratory technology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in pulmonary function</measure>
    <time_frame>Before and three months after nutrition supplementation</time_frame>
    <description>Differences in forced expiratory volume in first second(FEV1),forced vital capacity(FVC),forced expiratory volume in first second ratio of forced vital capacity(FEV1/FVC) measured by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in exercise capacity</measure>
    <time_frame>Before and three months after nutrition supplementation</time_frame>
    <description>Difference in walk distance by six minutes walk test(6MWT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in anthropometric indexes</measure>
    <time_frame>Before and three months after nutrition supplementation</time_frame>
    <description>Differences in triceps skinfold thickness（TSF）,mid-arm muscle circumference(MAMC), mid-arm circumference(MAC) measured by tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in degree of dyspnea</measure>
    <time_frame>Before and three months after nutrition supplementation</time_frame>
    <description>Difference in dyspnea measured by modified Medical British Research Council（mMRC）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life score</measure>
    <time_frame>Before and three months after nutrition supplementation</time_frame>
    <description>Differences in scores measured by Saint George Respiratory Questionaire score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in respiratory muscle function</measure>
    <time_frame>Before and three months after nutrition supplementation</time_frame>
    <description>Differences in maximal inspiratory pressure（PImax) and maximal expiratory pressure (PEmax) measured by respiratory muscle measurement instrument</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease(COPD)</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>blank control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nutrition supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to usual diet,the patients will be given enteral nutrition emulsion, which is a oral nutrition liquid composed of proteins,omega-3 fatty acids,carbohydrate,vitamins.Every package contains 200ml and provides 260 kcal energy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>enteral nutrition emulsion</intervention_name>
    <description>The patient should drink the oral nutritional supplements according to the estimated energy intake and make a record everyday.The patients will be followed up regularly.</description>
    <arm_group_label>nutrition supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients from Zhujiang Hospital affiliated from Southern Medical University&#xD;
&#xD;
        Patients aged between 40 and 90 years old&#xD;
&#xD;
        Patients gendered into male or female&#xD;
&#xD;
        Patients with pulmonary function test of FEV1/FVC&lt;70% and FEV1&lt;80% predicted&#xD;
&#xD;
        Patients presenting one or more of the following situations of malnutrition or nutritional&#xD;
        risk: BMI &lt;21 kg/m2 (or&lt;23 kg/m2 in patients ≥ 65); unintentional weight loss &gt;10% in the&#xD;
        past 6 months; unintentional weight loss &gt;5% in last month; FFMI &lt;15 kg/m2 (women) or &lt;16&#xD;
        kg/m2 (men)&#xD;
&#xD;
        Patients able to answer question&#xD;
&#xD;
        Patient able to eat and drink&#xD;
&#xD;
        Patients who signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with signs of an airway infection&#xD;
&#xD;
        Patients with malignant disorders&#xD;
&#xD;
        Patients with recent surgery&#xD;
&#xD;
        Patients with gastrointestinal ,cardiovascular diseases,neurological diseases or endocrine&#xD;
        disease&#xD;
&#xD;
        Patients with bullae lung&#xD;
&#xD;
        patients treated with oral steroids or immunosuppressors&#xD;
&#xD;
        Patients requiring other nutritional supplements or parenteral nutrition&#xD;
&#xD;
        Patients suffering from acute exacerbation over the previous 4 weeks&#xD;
&#xD;
        Patients with lack of motivation or poor compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Chen, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhujiang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liqing Wang, doctor</last_name>
    <phone>+86-02062783391</phone>
    <email>wliqing07@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhujiang Hospital,Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510282</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liqing Wang, doctor</last_name>
      <phone>+86-02062783391</phone>
      <email>wliqing07@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>malnutrition</keyword>
  <keyword>nutrition supplementation</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>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- 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/NCT02197871
org study id: CX20140718
nct id: NCT02197871
lead sponsor: 
collaborator: 
has dmc: Yes
Insufficient energy intake and systematic inflammation lead to malnutrition in patients with
      chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the
      patients'nutritional status by increasing energy intake and providing anti-inflammatory
      elements，which can relieve the patients' symptoms and delay the disease progression.
Malnutrition is very common in patients with COPD. The main reasons include short intake of
      energy and systematic inflammation. In our randomized and controlled clinical trial, patients
      will be divided into two groups: the experimental group and the control group. Patients in
      the experimental group will be provided nutritional supplements in addition to usual diet
      every day for three months and patients in the controlled group with usual diet. According to
      the changes of patients' body composition, anthropometrics, inflammatory markers, lung
      function, respiratory muscle function, exercise capacity, degree of dyspnea and health
      related quality of life(HRQL) after intervention，the nutritional status and inflammation
      status are assessed, which contributes to the prediction of prognosis. The nutritional
      supplements is a kind of oral liquid composed of proteins, omega-3 fatty acids, carbohydrate,
      vitamins, which provides about 260 kcal energy per 200ml. The patients from the
      interventional group need drink the nutritional supplements according to the estimated energy
      intake and a record should be made everyday. The patients will be followed up regularly by
      the researcher.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in nutritional status
time frame: Before and three months after nutrition supplementation
description: Differences in weight,muscle mass(MM),fat mass(FM),free fat mass(FFM),protein，body mass index(BMI),free fat mass index(FFMI) evaluated by bio-impedance measuring technology.
measure: Changes in the serum levels of inflammatory markers
time frame: Before and three months after nutrition supplementation
description: Changes in the serum levels of tumor necrosis factor-α(TNF-α)、interleukin-6（IL-6）、C-reactive protein(CRP) by laboratory technology.
measure: Changes in pulmonary function
time frame: Before and three months after nutrition supplementation
description: Differences in forced expiratory volume in first second(FEV1),forced vital capacity(FVC),forced expiratory volume in first second ratio of forced vital capacity(FEV1/FVC) measured by spirometry
measure: Changes in exercise capacity
time frame: Before and three months after nutrition supplementation
description: Difference in walk distance by six minutes walk test(6MWT)
measure: Changes in anthropometric indexes
time frame: Before and three months after nutrition supplementation
description: Differences in triceps skinfold thickness（TSF）,mid-arm muscle circumference(MAMC), mid-arm circumference(MAC) measured by tape
measure: Changes in degree of dyspnea
time frame: Before and three months after nutrition supplementation
description: Difference in dyspnea measured by modified Medical British Research Council（mMRC）
measure: Changes in quality of life score
time frame: Before and three months after nutrition supplementation
description: Differences in scores measured by Saint George Respiratory Questionaire score
measure: Changes in respiratory muscle function
time frame: Before and three months after nutrition supplementation
description: Differences in maximal inspiratory pressure（PImax) and maximal expiratory pressure (PEmax) measured by respiratory muscle measurement instrument
arm group label: blank control
arm group type: No Intervention
description: usual diet
arm group label: nutrition supplementation
arm group type: Experimental
description: In addition to usual diet,the patients will be given enteral nutrition emulsion, which is a oral nutrition liquid composed of proteins,omega-3 fatty acids,carbohydrate,vitamins.Every package contains 200ml and provides 260 kcal energy.
intervention type: Dietary Supplement
intervention name: enteral nutrition emulsion
description: The patient should drink the oral nutritional supplements according to the estimated energy intake and make a record everyday.The patients will be followed up regularly.
arm group label: nutrition supplementation
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Xin Chen, doctor
role: Principal Investigator
affiliation: Zhujiang Hospital
last name: Liqing Wang, doctor
phone: +86-02062783391
email: wliqing07@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Malnutrition