Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE

Study Overview
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Brief Summary
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Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE

Detailed Description
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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).

Official Title
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Tolerance and Acceptability of AYMES PRAGUE

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: AYMES PRAGUE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>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. | Dietary Supplement: AYMES PRAGUE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 9 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 9 days | 
| 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 | 9 days | 
| 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 | 9 days | 
| 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 | 9 days |