<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/NCT04474886</url>
  </required_header>
  <id_info>
    <org_study_id>2020.223</org_study_id>
    <nct_id>NCT04474886</nct_id>
  </id_info>
  <brief_title>Oral Nutritional Supplement for the Patient With or at Risk of Malnutrition</brief_title>
  <official_title>Intervention With Oral Nutritional Supplement (ONS) for the Patient With or at Risk of Malnutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fresenius Kabi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In case of acute and chronic illness nutritional problems are widespread, and a reduced&#xD;
      dietary intake in combination with effects of catabolic disease rapidly lead to malnutrition.&#xD;
      A high prevalence of protein energy malnutrition in patients has been reported. A close&#xD;
      relation between malnutrition and re-admission rate, cost of hospital care in terms of length&#xD;
      of stay in hospital as well as mortality has been documented. A Cochrane review of the use of&#xD;
      oral nutritional supplementation suggested that oral nutrition not only provided nutrients,&#xD;
      but also has significant improvements on psychological and social functions, possibly through&#xD;
      enhancing sensation of taste and flavor which is an important mediator of pleasure and&#xD;
      well-being. Therefore, an oral option of nutrition is always considered as the first choice&#xD;
      of nutritional intervention, in particular in situations where nutritional interventions,&#xD;
      such as assisted feeding, are difficult, time-consuming and demanding due to advanced&#xD;
      morbidity and slow responses. In this randomized controlled trial, the investigators will&#xD;
      explore the gaps of nutritional needs and the potential use of nutrition supplementation in&#xD;
      the management of malnutrition among patients in Hong Kong. The investigators aim to improve&#xD;
      the nutrient intakes and the nutritional status of participants through a specially&#xD;
      formulated oral nutrition supplement titled &quot;Fresubin® Powder Fibre&quot; to reverse malnutrition&#xD;
      status due to acute and chronic illness. Fresubin® Powder Fibre is a nutritionally complete&#xD;
      powder product to be reconstituted in different caloric densities (1.0 to 1.5 kcal/ml) and&#xD;
      containing high quality protein and vitamin D for the dietary management of participants with&#xD;
      or at the risk of malnutrition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2020</start_date>
  <completion_date type="Actual">February 24, 2022</completion_date>
  <primary_completion_date type="Actual">February 24, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>body weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in body weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in Body Mass Index. Height will be measured twice to the nearest 0.1 cm and body weight will be measured twice to the nearest 0.1 kg. BMI will be calculated as body weight in kg / (height in m)2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini Nutritional Assessment-short form(MNA-SF)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in MNA-SF would be used to examine the nutritional status of the participants. The scale of this test would be 0 to 14. Malnutrition or at risk of malnutrition will be classified as having a score of 11 or below. Score of 12-14 would be defined as normal nutritional status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12 Health Survey</measure>
    <time_frame>12 weeks</time_frame>
    <description>Health-related quality of life will be measured with the validated Chinese version of SF-12, which includes physical and mental domains. Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100. Higher score indicates better health-related quality of life in both domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated health</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-rated health will be elicited by a single question, &quot;Generally speaking, how is your health: excellent, very good, good, fair, or poor?&quot;The scale would 1 to 5 and a lower score indicates worse self-rated health in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-item FRAIL scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>The 5-item FRAIL scale will be measured.A score of 1 is assigned to each of the five components: fatigue, resistance (i.e. inability to climb up 10 steps), ambulation (i.e. inability to walk two to three blocks), having more than five diseases, and recent weight loss of more than 5%. Frailty scores range from 0 to 5 and represent frail (3 to 5), pre-frail (1 to 2), and robust (0) health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-day dietary record</measure>
    <time_frame>12 weeks</time_frame>
    <description>3-day dietary record will be used to capture dietary intake for 3 days. The days of recording will be randomly assigned so that all days of the week, including weekend days, will be equally represented. Instructions about recording type of foods and how to estimate the portion sizes in household measures will be given. On the scheduled visit, the trained personnel will check the dietary records for completeness, obtain additional information about unclear items or amounts, and use examples of household measures to improve the estimation. The daily nutrient intake will be calculated by the Food Processor Nutrition analysis and Fitness software version 8.0 (ESHA Research, Salem, USA), with addition of composition of local foods based on food composition table from China and Hong Kong. Change in diet quality in terms of energy intake would be measured as outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mid-arm circumference (MAC)</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of MAC in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>calf circumference</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of calf circumference in cm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Fresubin® powder fibre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 servings of Fresubin® powder fibre per day as supplement to normal diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Maintain usual diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fresubin® powder fibre</intervention_name>
    <description>2 servings per day</description>
    <arm_group_label>Fresubin® powder fibre</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese origin aged 18 or above&#xD;
&#xD;
          -  Normally reside in Hong Kong&#xD;
&#xD;
          -  Could speak and understand Chinese&#xD;
&#xD;
          -  Being screened as malnourished or at risk of malnutrition using the Mini Nutritional&#xD;
             Assessment-Short Form (MNA-SF) with a score at 11 or below&#xD;
&#xD;
          -  Willing to follow the study procedures&#xD;
&#xD;
          -  Written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent (i.e. past 3 months) or concurrent participation in any clinical trial or&#xD;
             dietary intervention program&#xD;
&#xD;
          -  Self-reported allergy or intolerance to the ingredients of the nutrition supplement&#xD;
&#xD;
          -  Consumption of additional ONS, tube feeding or parenteral nutrition&#xD;
&#xD;
          -  Use of medications (Amphetamine and its derivatives, Levothyroxine, Biguanides) that&#xD;
             could affect study outcomes&#xD;
&#xD;
          -  With cancer conditions that are currently undergoing treatment&#xD;
&#xD;
          -  Poorly controlled or unstable chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Poorly controlled or unstable cardiovascular disease or diabetes or hypertension&#xD;
&#xD;
          -  Recent unhealed bone fracture (within the past 12 months)&#xD;
&#xD;
          -  Existing gastrointestinal (GI) diseases or pathological findings, which do not allow&#xD;
             enteral feeding, e.g. intestinal atony, ileus, acute upper GI bleeding, shock, or&#xD;
             malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous&#xD;
             surgical GI resection&#xD;
&#xD;
          -  Severely impaired gastrointestinal function, i.e. severe constipation or acute&#xD;
             diarrhea (≥ 3 loose or watery stools per day)&#xD;
&#xD;
          -  Dysphagia or high aspiration risk&#xD;
&#xD;
          -  Long-term bedridden&#xD;
&#xD;
          -  Liver failure or severe renal insufficiency (i.e. significant renal impairment at eGFR&#xD;
             of &lt;30 ml/min, or significant liver impairment as indicated by ALT&gt;100 or history of&#xD;
             liver cirrhosis) in the past 3 months before enrollment&#xD;
&#xD;
          -  Relevant central nervous system and/or psychiatric disorders, i.e. Stroke, Alzheimer's&#xD;
             disease, Parkinson's disease, traumatic brain injury, depression or other mood&#xD;
             disorders&#xD;
&#xD;
          -  Planned surgery or hospitalization during study period&#xD;
&#xD;
          -  With any other indication of a major medical or psychological illness, as judged by&#xD;
             the investigators as ineligible to participate the study&#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>Timothy Kwok, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Timothy Kwok</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </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/NCT04474886
org study id: 2020.223
nct id: NCT04474886
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In case of acute and chronic illness nutritional problems are widespread, and a reduced
      dietary intake in combination with effects of catabolic disease rapidly lead to malnutrition.
      A high prevalence of protein energy malnutrition in patients has been reported. A close
      relation between malnutrition and re-admission rate, cost of hospital care in terms of length
      of stay in hospital as well as mortality has been documented. A Cochrane review of the use of
      oral nutritional supplementation suggested that oral nutrition not only provided nutrients,
      but also has significant improvements on psychological and social functions, possibly through
      enhancing sensation of taste and flavor which is an important mediator of pleasure and
      well-being. Therefore, an oral option of nutrition is always considered as the first choice
      of nutritional intervention, in particular in situations where nutritional interventions,
      such as assisted feeding, are difficult, time-consuming and demanding due to advanced
      morbidity and slow responses. In this randomized controlled trial, the investigators will
      explore the gaps of nutritional needs and the potential use of nutrition supplementation in
      the management of malnutrition among patients in Hong Kong. The investigators aim to improve
      the nutrient intakes and the nutritional status of participants through a specially
      formulated oral nutrition supplement titled "Fresubin® Powder Fibre" to reverse malnutrition
      status due to acute and chronic illness. Fresubin® Powder Fibre is a nutritionally complete
      powder product to be reconstituted in different caloric densities (1.0 to 1.5 kcal/ml) and
      containing high quality protein and vitamin D for the dietary management of participants with
      or at the risk of malnutrition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: body weight
time frame: 12 weeks
description: Change in body weight
measure: Body Mass Index
time frame: 12 weeks
description: Change in Body Mass Index. Height will be measured twice to the nearest 0.1 cm and body weight will be measured twice to the nearest 0.1 kg. BMI will be calculated as body weight in kg / (height in m)2.
measure: Mini Nutritional Assessment-short form(MNA-SF)
time frame: 12 weeks
description: Change in MNA-SF would be used to examine the nutritional status of the participants. The scale of this test would be 0 to 14. Malnutrition or at risk of malnutrition will be classified as having a score of 11 or below. Score of 12-14 would be defined as normal nutritional status.
measure: SF-12 Health Survey
time frame: 12 weeks
description: Health-related quality of life will be measured with the validated Chinese version of SF-12, which includes physical and mental domains. Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100. Higher score indicates better health-related quality of life in both domains.
measure: Self-rated health
time frame: 12 weeks
description: Self-rated health will be elicited by a single question, "Generally speaking, how is your health: excellent, very good, good, fair, or poor?"The scale would 1 to 5 and a lower score indicates worse self-rated health in this study.
measure: 5-item FRAIL scale
time frame: 12 weeks
description: The 5-item FRAIL scale will be measured.A score of 1 is assigned to each of the five components: fatigue, resistance (i.e. inability to climb up 10 steps), ambulation (i.e. inability to walk two to three blocks), having more than five diseases, and recent weight loss of more than 5%. Frailty scores range from 0 to 5 and represent frail (3 to 5), pre-frail (1 to 2), and robust (0) health status.
measure: 3-day dietary record
time frame: 12 weeks
description: 3-day dietary record will be used to capture dietary intake for 3 days. The days of recording will be randomly assigned so that all days of the week, including weekend days, will be equally represented. Instructions about recording type of foods and how to estimate the portion sizes in household measures will be given. On the scheduled visit, the trained personnel will check the dietary records for completeness, obtain additional information about unclear items or amounts, and use examples of household measures to improve the estimation. The daily nutrient intake will be calculated by the Food Processor Nutrition analysis and Fitness software version 8.0 (ESHA Research, Salem, USA), with addition of composition of local foods based on food composition table from China and Hong Kong. Change in diet quality in terms of energy intake would be measured as outcome.
measure: mid-arm circumference (MAC)
time frame: 12 weeks
description: change of MAC in cm
measure: calf circumference
time frame: 12 weeks
description: change of calf circumference in cm
arm group label: Fresubin® powder fibre
arm group type: Experimental
description: 2 servings of Fresubin® powder fibre per day as supplement to normal diet
arm group label: Usual diet
arm group type: No Intervention
description: Maintain usual diet
intervention type: Dietary Supplement
intervention name: Fresubin® powder fibre
description: 2 servings per day
arm group label: Fresubin® powder fibre
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy Kwok, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Timothy Kwok
investigator title: professor
mesh term: Malnutrition
sharing ipd: No