Back to resultsAcceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AYMES PRAGUE
Sponsored by
About this trial
This is an interventional other trial for Malnutrition
Eligibility Criteria
Inclusion Criteria:
- Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
- Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/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 swallowing impairment requiring thickened fluids
- Patients with inflammatory bowel disease or previous bowel resection.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention
Arm Description
Patients established on an oral nutritional supplement, being prescribed 1-2 oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of AYMES PRAGUE for a period of 9 days.
Outcomes
Primary Outcome Measures
GI side effects when using AYMES PRAGUE
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES PRAGUE as assessed by presence / absence of side effect compared to baseline period
Secondary Outcome Measures
Change to bodyweight of subjects when using AYMES PRAGUE
Recording of bodyweight (in kg) at start of study, start of intervention and end of intervention for comparison to investigate any trend in weight change during the intervention period compared to baseline
Compliance with prescription of AYMES PRAGUE
Recording of amount of AYMES PRAGUE 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 AYMES PRAGUE
Bowel habits of subjects when using AYMES PRAGUE - frequency
Recording of bowel habits whilst subjects consuming AYMES PRAGUE, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period
Bowel habits of subjects when using AYMES PRAGUE - stool consistency
Recording of bowel habits whilst subjects consuming AYMES PRAGUE, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period
Full Information
NCT ID
NCT02831647
First Posted
July 11, 2016
Last Updated
January 6, 2020
Sponsor
Aymes International Limited
Collaborators
Eat Well Now
1. Study Identification
Unique Protocol Identification Number
NCT02831647
Brief Title
Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE
Official Title
Tolerance and Acceptability of AYMES PRAGUE
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aymes International Limited
Collaborators
Eat Well Now
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE
Detailed Description
To evaluate tolerance and acceptability of AYMES PRAGUE 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 AYMES PRAGUE (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
intervention
Arm Type
Experimental
Arm Description
Patients established on an oral nutritional supplement, being prescribed 1-2 oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of AYMES PRAGUE for a period of 9 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
AYMES PRAGUE
Intervention Description
AYMES PRAGUE is a ready to drink, high energy, low volume oral nutritional supplement drink. It provides 300 kcal and 12g protein per 125ml serving. It 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.
Primary Outcome Measure Information:
Title
GI side effects when using AYMES PRAGUE
Description
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES PRAGUE as assessed by presence / absence of side effect compared to baseline period
Time Frame
9 DAYS
Secondary Outcome Measure Information:
Title
Change to bodyweight of subjects when using AYMES PRAGUE
Description
Recording of bodyweight (in kg) at start of study, start of intervention and end of intervention for comparison to investigate any trend in weight change during the intervention period compared to baseline
Time Frame
9 days
Title
Compliance with prescription of AYMES PRAGUE
Description
Recording of amount of AYMES PRAGUE 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 AYMES PRAGUE
Time Frame
9 days
Title
Bowel habits of subjects when using AYMES PRAGUE - frequency
Description
Recording of bowel habits whilst subjects consuming AYMES PRAGUE, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period
Time Frame
9 days
Title
Bowel habits of subjects when using AYMES PRAGUE - stool consistency
Description
Recording of bowel habits whilst subjects consuming AYMES PRAGUE, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/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 swallowing impairment requiring thickened fluids
Patients with inflammatory bowel disease or previous bowel resection.
12. IPD Sharing Statement
Plan to Share IPD
No
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Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE
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