<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/NCT03836274</url>
  </required_header>
  <id_info>
    <org_study_id>AY:ASK-SCH</org_study_id>
    <nct_id>NCT03836274</nct_id>
  </id_info>
  <brief_title>Tolerance and Acceptability Evaluation of MONACO</brief_title>
  <official_title>Tolerance and Acceptability Evaluation of MONACO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aymes International Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aymes International Limited</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>
      To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral&#xD;
      nutritional support compared with currently available alternatives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral&#xD;
      nutritional support compared with currently available alternatives, measuring outcomes of GI&#xD;
      effects, Compliance, product preference, convenience etc.&#xD;
&#xD;
      To obtain data to support an ACBS submissions for 'MONACO' (to allow for prescription in the&#xD;
      community at NHS expense).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GI Tolerance</measure>
    <time_frame>9 Days</time_frame>
    <description>To assess gastro-intestinal tolerance of 'MONACO' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire</measure>
    <time_frame>9 days</time_frame>
    <description>To assess the acceptability of 'MONACO' in patients in the community requiring oral nutritional supplementation. At the end of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new supplement drink. A 5 point hedonic scale will be used.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'MONACO' for a period of 9 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>AYMES MONACO</intervention_name>
    <description>AYMES MONACO is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients (&gt;18 years) who are able to communicate clearly.&#xD;
&#xD;
          -  Patients with or at risk of malnutrition as determined by growth charts and/or by&#xD;
             professional clinical judgement.&#xD;
&#xD;
          -  Patients expected to require oral nutritional supplementation for at least 2 further&#xD;
             weeks.&#xD;
&#xD;
          -  Patients requiring supplementary intake approximately 300 kcal /day from an oral&#xD;
             nutritional supplement&#xD;
&#xD;
          -  Informed assent/consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cow's milk protein allergy requiring a milk free diet&#xD;
&#xD;
          -  Patients with inherited metabolic conditions.&#xD;
&#xD;
          -  Patients requiring enteral tube feeding or parenteral nutrition.&#xD;
&#xD;
          -  Patients with medical or dietary contraindication to any feed ingredients (see&#xD;
             appendix 2 for full ingredient list)&#xD;
&#xD;
          -  Patients with significant renal (requiring dialysis) or hepatic impairment (e.g.&#xD;
             hepatitis)&#xD;
&#xD;
          -  Patients with dysphagia requiring stage 1, 2 or 3 thickened fluids.&#xD;
&#xD;
          -  Patients with uncontrolled inflammatory bowel disease or previous bowel resection with&#xD;
             ongoing gastrointestinal symptoms.&#xD;
&#xD;
          -  Patients for whom the investigator has concerns regarding the ability or willingness&#xD;
             of the patient and or carer to comply with protocol requirements&#xD;
&#xD;
          -  Participation in any other studies involving investigational or marketed products&#xD;
             concomitantly or within 2 weeks prior to entry into 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>
  <location>
    <facility>
      <name>AYMES International</name>
      <address>
        <city>Haywards Heath</city>
        <zip>RH16 9PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 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/NCT03836274
org study id: AY:ASK-SCH
nct id: NCT03836274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral
      nutritional support compared with currently available alternatives.
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral
      nutritional support compared with currently available alternatives, measuring outcomes of GI
      effects, Compliance, product preference, convenience etc.

      To obtain data to support an ACBS submissions for 'MONACO' (to allow for prescription in the
      community at NHS expense).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: GI Tolerance
time frame: 9 Days
description: To assess gastro-intestinal tolerance of 'MONACO' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.
measure: Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
time frame: 9 days
description: To assess the acceptability of 'MONACO' in patients in the community requiring oral nutritional supplementation. At the end of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new supplement drink. A 5 point hedonic scale will be used.
arm group label: Experimental
arm group type: Experimental
description: Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'MONACO' for a period of 9 days.
intervention type: Dietary Supplement
intervention name: AYMES MONACO
description: AYMES MONACO is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No