<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/NCT03245047</url>
  </required_header>
  <id_info>
    <org_study_id>BL35 (Part 2)</org_study_id>
    <nct_id>NCT03245047</nct_id>
  </id_info>
  <brief_title>The Nutritional Health for the Elderly Reference Centre Study (The NHERC Study)</brief_title>
  <acronym>NHERC</acronym>
  <official_title>A Prospective Randomized Double Blind Clinical Study to Determine the Clinical Impact of ONS in Community-dwelling Elderly</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>
      The prevalence of malnutrition among the elderly in Asia is high. The objective of this&#xD;
      randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of&#xD;
      consuming an adult ONS plus dietary counseling (intervention group) for 180 days on&#xD;
      nutritional status and unexpected hospital (re)admission, compared with a placebo supplement&#xD;
      plus dietary counseling (control group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled trial will involve 800 elderly who are at risk of undernutrition&#xD;
      (MUST score ≥ 1). Participants will be screened for eligibility. Recruitment will be at the&#xD;
      polyclinic and in the inpatient ward prior to their discharge from the hospital. Participants&#xD;
      will be randomized to intervention group vs. control group at the baseline visit at the&#xD;
      clinical trial research unit where baseline measurements and baseline survey using the study&#xD;
      specific questionnaires will be performed. Participants will be followed up prospectively at&#xD;
      Day 30, Day 90, Day 180 (exit visit), and Day 360 (post-intervention follow-up visit).&#xD;
      Repeated measures will be performed at the pre-defined time points. Intention-to-treat&#xD;
      analysis comparing intervention group vs. control group will be performed to study the effect&#xD;
      of ONS on primary composite outcome consisting of (i) change in body weight from baseline to&#xD;
      Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period. The&#xD;
      effect of ONS on nutritional status will be examined by comparing the biochemical and&#xD;
      anthropometric measurements of intervention group vs. control group at Day 180. Other&#xD;
      outcomes such as changes in functional assessment, nutritional knowledge levels, and quality&#xD;
      of life will also be examined. There will be a follow up visit at Day 360.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 10, 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>
    <intervention_model_description>This is a prospective, randomized, placebo controlled, double-blind, parallel design, multi-center study. Eligible participants will be randomly allocated to one of two groups: oral nutritional supplement with dietary counseling group or placebo supplement with dietary counseling group. Randomization will be stratified by MUST malnutrition status (medium risk or high risk) and site of recruitment. All participants, including both recently discharged patients from the hospital or elderly recruited from the polyclinics.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>This study is double-blinded, i.e., during the study, neither the investigator(s), study and appropriate Abbott Nutrition staff, nor participants will be informed of the identity of any of the study products. Study center personnel will not analyze the contents of the study products or in any way seek to learn the identity of the study products. The investigator should ensure that if it becomes necessary, blinding is broken only in accordance with the protocol.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Primary composite outcome consisting of change in body weight and unexpected hospital admission</measure>
    <time_frame>baseline to Day 180</time_frame>
    <description>(i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period (Death before any unexpected admission to the hospital will be counted as a hospitalization event)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fat mass and fat free mass</measure>
    <time_frame>Baseline, 30 days, 90 days and 180 days]</time_frame>
    <description>Fat mass and fat free mass in kilograms will be measured using Tanita MC-780</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay of unexpected hospital admission(s)</measure>
    <time_frame>90 days &amp; 180 days</time_frame>
    <description>Unexpected admission to the hospital over 90-day and 180-day intervention periods</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">811</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary Supplement: Oral Nutritional Supplement with AN777 Participants in the intervention group will be asked to consume two servings of oral nutritional supplement per day for 180 days. (Oral Consumption)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the control group will be asked to consume two servings of Oral nutritional supplement per day for 180 days.(Oral Consumption)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral Nutritional Supplement with AN 777</intervention_name>
    <description>Oral Nutritional Supplement with AN 777, 2 servings a day</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral Nutritional Supplement</intervention_name>
    <description>Oral Nutritional Supplement, 2 servings a day</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <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;
          9. Participant has been identified as at risk of undernutrition as defined by&#xD;
             Malnutrition Universal Screening Tool.&#xD;
&#xD;
         10. Participant is willing to refrain from taking non-study oral nutritional supplements&#xD;
             including protein powder over the entire course of the study.&#xD;
&#xD;
         11. Participant is able and willing to follow study procedures and record data in diary&#xD;
             and complete any forms or assessments needed throughout the study, with or without the&#xD;
             help of the caregivers.&#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;
&#xD;
          9. Participant has been diagnosed or is known to be allergic or intolerant to milk&#xD;
             products.&#xD;
&#xD;
         10. Participant has continuous ONS usage for 30 days prior to the screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Agnes 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>March 2021</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</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/NCT03245047
org study id: BL35 (Part 2)
nct id: NCT03245047
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prevalence of malnutrition among the elderly in Asia is high. The objective of this
      randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of
      consuming an adult ONS plus dietary counseling (intervention group) for 180 days on
      nutritional status and unexpected hospital (re)admission, compared with a placebo supplement
      plus dietary counseling (control group).
This randomized controlled trial will involve 800 elderly who are at risk of undernutrition
      (MUST score ≥ 1). Participants will be screened for eligibility. Recruitment will be at the
      polyclinic and in the inpatient ward prior to their discharge from the hospital. Participants
      will be randomized to intervention group vs. control group at the baseline visit at the
      clinical trial research unit where baseline measurements and baseline survey using the study
      specific questionnaires will be performed. Participants will be followed up prospectively at
      Day 30, Day 90, Day 180 (exit visit), and Day 360 (post-intervention follow-up visit).
      Repeated measures will be performed at the pre-defined time points. Intention-to-treat
      analysis comparing intervention group vs. control group will be performed to study the effect
      of ONS on primary composite outcome consisting of (i) change in body weight from baseline to
      Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period. The
      effect of ONS on nutritional status will be examined by comparing the biochemical and
      anthropometric measurements of intervention group vs. control group at Day 180. Other
      outcomes such as changes in functional assessment, nutritional knowledge levels, and quality
      of life will also be examined. There will be a follow up visit at Day 360.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a prospective, randomized, placebo controlled, double-blind, parallel design, multi-center study. Eligible participants will be randomly allocated to one of two groups: oral nutritional supplement with dietary counseling group or placebo supplement with dietary counseling group. Randomization will be stratified by MUST malnutrition status (medium risk or high risk) and site of recruitment. All participants, including both recently discharged patients from the hospital or elderly recruited from the polyclinics.
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: This study is double-blinded, i.e., during the study, neither the investigator(s), study and appropriate Abbott Nutrition staff, nor participants will be informed of the identity of any of the study products. Study center personnel will not analyze the contents of the study products or in any way seek to learn the identity of the study products. The investigator should ensure that if it becomes necessary, blinding is broken only in accordance with the protocol.
measure: Primary composite outcome consisting of change in body weight and unexpected hospital admission
time frame: baseline to Day 180
description: (i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period (Death before any unexpected admission to the hospital will be counted as a hospitalization event)
measure: Fat mass and fat free mass
time frame: Baseline, 30 days, 90 days and 180 days]
description: Fat mass and fat free mass in kilograms will be measured using Tanita MC-780
measure: Length of stay of unexpected hospital admission(s)
time frame: 90 days & 180 days
description: Unexpected admission to the hospital over 90-day and 180-day intervention periods
arm group label: Intervention group
arm group type: Experimental
description: Dietary Supplement: Oral Nutritional Supplement with AN777 Participants in the intervention group will be asked to consume two servings of oral nutritional supplement per day for 180 days. (Oral Consumption)
arm group label: Control group
arm group type: Placebo Comparator
description: Participants in the control group will be asked to consume two servings of Oral nutritional supplement per day for 180 days.(Oral Consumption)
intervention type: Dietary Supplement
intervention name: Oral Nutritional Supplement with AN 777
description: Oral Nutritional Supplement with AN 777, 2 servings a day
arm group label: Intervention group
intervention type: Other
intervention name: Oral Nutritional Supplement
description: Oral Nutritional Supplement, 2 servings a day
arm group label: Control group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 110 Years
healthy volunteers: No
last name: Agnes 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