<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/NCT03240952</url>
  </required_header>
  <id_info>
    <org_study_id>BL35 (Part 1)</org_study_id>
    <nct_id>NCT03240952</nct_id>
  </id_info>
  <brief_title>The Nutritional Health for the Elderly Reference Centre Study (NHERC Study)</brief_title>
  <acronym>NHERC</acronym>
  <official_title>Establishing Reference Range for Community-dwelling Elderly Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SingHealth Polyclinics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abbott Nutrition</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>
      Elderly are at greater risk of dietary insufficiency due to age-related increases in nutrient&#xD;
      requirements concomitant with a reduction in energy requirements, decreases in appetite and&#xD;
      energy intake. Currently there is a gap in knowledge of the factors that are associated with&#xD;
      malnutrition in the elderly in Singapore. In addition, there is no &quot;reference&quot; database on&#xD;
      anthropometric measurements and biochemical indices for elderly with a range of nutrition&#xD;
      status in Singapore. Thus, the objectives of this cross-sectional study are to examine&#xD;
      factors influencing nutritional status and to determine the reference values for&#xD;
      anthropometric and biochemical measurements related to nutritional status for&#xD;
      community-dwelling elderly in Singapore.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional study. Measurements will be taken at baseline for elderly with&#xD;
      normal nutrition (n = 400) and elderly who are at risk of under nutrition (n = 800).. These&#xD;
      measurements will be used to examine factors influencing nutritional status and to create a&#xD;
      &quot;reference&quot; database for anthropometric and biochemical measurements related to nutritional&#xD;
      status for use in clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">July 26, 2018</completion_date>
  <primary_completion_date type="Actual">May 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MUST</measure>
    <time_frame>Baseline</time_frame>
    <description>Malnutrition risk using Malnutrition Universal Screening Tool</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight, fat mass, fat free mass</measure>
    <time_frame>Baseline</time_frame>
    <description>Body weight, fat mass, fat free mass in kilograms will be measured using Tanita MC-780</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-albumin</measure>
    <time_frame>Baseline</time_frame>
    <description>Pre-albumin in mg/dL will be measured using Cobas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin and total protein</measure>
    <time_frame>Baseline</time_frame>
    <description>Albumin and total protein in g/L will be measured using Cobas</description>
  </secondary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Malnutrition</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This cross-sectional study will include 400 elderly with normal nutrition (MUST score: 0)&#xD;
        and 800 elderly who are at risk of undernutrition (MUST score ≥ 1). Community-dwelling&#xD;
        elderly recently discharged from the hospital as well as those who recently visited&#xD;
        polyclinics in Singapore will be recruited for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female participant aged ≥65 years.&#xD;
&#xD;
          2. Community-dweller, i.e. not staying in a residential intermediate and long-term care&#xD;
             (ILTC) service institution.&#xD;
&#xD;
          3. Participant is being discharged home directly (applicable for hospital cohort).&#xD;
&#xD;
          4. Participant is community ambulant with or without aid.&#xD;
&#xD;
          5. Participant does not have any chronic disease(s) or has stable chronic disease(s)&#xD;
             including hypertension, chronic obstructive pulmonary disease, and cardiovascular&#xD;
             disease in the opinion of the Study Physician, at study entry.&#xD;
&#xD;
          6. Participant has voluntarily signed and dated an informed consent form (ICF), approved&#xD;
             by an Institutional Review Board (IRB) and provided authorization prior to any&#xD;
             participation in the study.&#xD;
&#xD;
          7. Participants will be able to communicate and follow instructions.&#xD;
&#xD;
          8. Participant is able to consume food and beverages orally.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participant has been diagnosed with dementia according to medical records.&#xD;
&#xD;
          2. Participant has been diagnosed with type 1 or type 2 diabetes according to medical&#xD;
             records. (Note: This includes participant with controlled diabetes.)&#xD;
&#xD;
          3. Participant has any active infectious disease (such as tuberculosis, Hepatitis B or C,&#xD;
             HIV infection) according to medical records.&#xD;
&#xD;
          4. Participant has been diagnosed with severe gastrointestinal disorders including celiac&#xD;
             disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according&#xD;
             to medical records.&#xD;
&#xD;
          5. Participant has been diagnosed with end stage organ or pre-terminal diseases or acute&#xD;
             myocardial infarction within the last 30 days from the screening according to medical&#xD;
             records.&#xD;
&#xD;
          6. Participant has malignancy according to medical records.&#xD;
&#xD;
          7. Participant has any other clinically significant medical condition, which in the&#xD;
             investigator's opinion, makes him or her unsuitable for inclusion in the study.&#xD;
&#xD;
          8. Participant is taking part in another study that has not been approved as a&#xD;
             concomitant study by the study team.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siew Ling Tey, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott Nutrition Research &amp; Development</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samuel TH Chew, MB.BCh.BAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changi General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marine Parade Polyclinic</name>
      <address>
        <city>Singapore</city>
        <zip>440080</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bedok Polyclinic</name>
      <address>
        <city>Singapore</city>
        <zip>460212</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampines Polyclinic</name>
      <address>
        <city>Singapore</city>
        <zip>529203</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>April 13, 2020</last_update_submitted>
  <last_update_submitted_qc>April 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT03240952
org study id: BL35 (Part 1)
nct id: NCT03240952
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Elderly are at greater risk of dietary insufficiency due to age-related increases in nutrient
      requirements concomitant with a reduction in energy requirements, decreases in appetite and
      energy intake. Currently there is a gap in knowledge of the factors that are associated with
      malnutrition in the elderly in Singapore. In addition, there is no "reference" database on
      anthropometric measurements and biochemical indices for elderly with a range of nutrition
      status in Singapore. Thus, the objectives of this cross-sectional study are to examine
      factors influencing nutritional status and to determine the reference values for
      anthropometric and biochemical measurements related to nutritional status for
      community-dwelling elderly in Singapore.
This is a cross-sectional study. Measurements will be taken at baseline for elderly with
      normal nutrition (n = 400) and elderly who are at risk of under nutrition (n = 800).. These
      measurements will be used to examine factors influencing nutritional status and to create a
      "reference" database for anthropometric and biochemical measurements related to nutritional
      status for use in clinical practice.
observational model: Cohort
time perspective: Cross-Sectional
measure: MUST
time frame: Baseline
description: Malnutrition risk using Malnutrition Universal Screening Tool
measure: Body weight, fat mass, fat free mass
time frame: Baseline
description: Body weight, fat mass, fat free mass in kilograms will be measured using Tanita MC-780
measure: Pre-albumin
time frame: Baseline
description: Pre-albumin in mg/dL will be measured using Cobas
measure: Albumin and total protein
time frame: Baseline
description: Albumin and total protein in g/L will be measured using Cobas
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 110 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Siew Ling Tey, Ph.D.
role: Study Chair
affiliation: Abbott Nutrition Research & Development
last name: Samuel TH Chew, MB.BCh.BAO
role: Principal Investigator
affiliation: Changi General Hospital
facility: 
facility: 
facility: 
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No