<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/NCT03013803</url>
  </required_header>
  <id_info>
    <org_study_id>HC-G-H-1610</org_study_id>
    <nct_id>NCT03013803</nct_id>
  </id_info>
  <brief_title>Acceptability Study on Nutricomp® Drink Plus Fibre in Adults</brief_title>
  <acronym>Fuchsia</acronym>
  <official_title>Acceptability Study on Nutricomp® Drink Plus Fibre in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B. Braun Melsungen AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B. Braun Melsungen AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study&#xD;
      is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to&#xD;
      show that it is acceptable for patients in the United Kingdom.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of gastrointestinal tolerance parameters</measure>
    <time_frame>Day 1 - day 13</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)</measure>
    <time_frame>Day 1 - day 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang</measure>
    <time_frame>Day 1 - day 13</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Adult Patients in Need of High-energy Oral Nutritional Supplementation</condition>
  <arm_group>
    <arm_group_label>Nutricomp Drink Plus Fibre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutricomp Drink Plus Fibre</intervention_name>
    <arm_group_label>Nutricomp Drink Plus Fibre</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Male and female participants ≥ 18 years of age&#xD;
&#xD;
          -  Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the&#xD;
             investigator team. Assessment to include, but not limited to weight loss history,&#xD;
             current BMI/MUST score, anamnesis, dietary intake history and predicted future oral&#xD;
             intake.&#xD;
&#xD;
          -  Anticipated period of nutritional support ≥ 12 days&#xD;
&#xD;
          -  Patient has the capacity and is willing to provide informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Participants with mental in capabilities who are unable to give informed consent&#xD;
&#xD;
          -  Hypersensitivity to any of the active substances or excipients within the IP&#xD;
&#xD;
          -  Severely impaired gastrointestinal function or complete failure&#xD;
&#xD;
          -  More than 50% of nutrition from Parenteral Nutrition&#xD;
&#xD;
          -  Simultaneous participation in another interventional study&#xD;
&#xD;
          -  Participants who are unwilling or mentally and/or physically unable to adhere to study&#xD;
             procedures&#xD;
&#xD;
          -  Participants with dysphagia requiring thickened fluids&#xD;
&#xD;
          -  Participants with significant renal impairment (CKD)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AC Health &amp; Nutrition Ltd</name>
      <address>
        <city>Leigh On Sea</city>
        <zip>SS9 3AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03013803
org study id: HC-G-H-1610
nct id: NCT03013803
lead sponsor: 
has dmc: No
Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study
      is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to
      show that it is acceptable for patients in the United Kingdom.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of gastrointestinal tolerance parameters
time frame: Day 1 - day 13
measure: Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)
time frame: Day 1 - day 13
measure: Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang
time frame: Day 1 - day 13
arm group label: Nutricomp Drink Plus Fibre
arm group type: Experimental
description: Nutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate)
intervention type: Dietary Supplement
intervention name: Nutricomp Drink Plus Fibre
arm group label: Nutricomp Drink Plus Fibre
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor