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Tolerance and Acceptability Evaluation of STOCKHOLM

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
STOCKHOLM
Sponsored by
Aymes International Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are able to communicate their views regarding acceptability.
  • Patients established on an oral nutritional supplement, being prescribed ONS providing approximately 300 kcal/day
  • Patients expected to require oral nutritional supplementation for at least 2 further weeks.
  • Informed consent obtained.

Exclusion Criteria:

  • Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
  • Patients requiring a milk free diet
  • Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
  • Patients with significant renal or hepatic impairment
  • Patients with dysphagia requiring stage 1,2 or 3 thickened fluids
  • Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.

Sites / Locations

  • Gemma Fry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Patients established on an oral nutritional supplement, being prescribed oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of STOCKHOLM for a period of 9 days.

Outcomes

Primary Outcome Measures

GI Tolerance
To assess gastro-intestinal tolerance of 'STOCKHOLM' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements as assessed on the Bristol stool form scale, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.

Secondary Outcome Measures

Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire
To assess the acceptability of 'STOCKHOLM' 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.
Compliance with Prescription of STOCKHOLM
Recording of amount of STOCKHOLM consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of STOCKHOLM.

Full Information

First Posted
February 6, 2019
Last Updated
January 5, 2021
Sponsor
Aymes International Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03844373
Brief Title
Tolerance and Acceptability Evaluation of STOCKHOLM
Official Title
Tolerance and Acceptability Evaluation of STOCKHOLM
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aymes International Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.
Detailed Description
To evaluate tolerance and acceptability of 'STOCKHOLM' in patients requiring supplementary oral nutritional support compared with currently available alternatives. To obtain data to support an ACBS submissions for 'STOCKHOLM' (to allow for prescription in the community at NHS expense).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients established on an oral nutritional supplement, being prescribed oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of STOCKHOLM for a period of 9 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
STOCKHOLM
Intervention Description
STOCKHOLM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision.
Primary Outcome Measure Information:
Title
GI Tolerance
Description
To assess gastro-intestinal tolerance of 'STOCKHOLM' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements as assessed on the Bristol stool form scale, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.
Time Frame
9 Days
Secondary Outcome Measure Information:
Title
Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire
Description
To assess the acceptability of 'STOCKHOLM' 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.
Time Frame
9 days
Title
Compliance with Prescription of STOCKHOLM
Description
Recording of amount of STOCKHOLM consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of STOCKHOLM.
Time Frame
9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are able to communicate their views regarding acceptability. Patients established on an oral nutritional supplement, being prescribed ONS providing approximately 300 kcal/day Patients expected to require oral nutritional supplementation for at least 2 further weeks. Informed consent obtained. Exclusion Criteria: Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study Patients requiring a milk free diet Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list) Patients with significant renal or hepatic impairment Patients with dysphagia requiring stage 1,2 or 3 thickened fluids Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
Facility Information:
Facility Name
Gemma Fry
City
Haywards Heath
ZIP/Postal Code
RH16 9PL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Tolerance and Acceptability Evaluation of STOCKHOLM

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