Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE
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|ClinicalTrials.gov Identifier: NCT02831647|
Recruitment Status : Not yet recruiting
First Posted : July 13, 2016
Last Update Posted : September 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Dietary Supplement: AYMES PRAGUE||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tolerance and Acceptability of AYMES PRAGUE|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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
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.
- GI side effects when using AYMES PRAGUE [ Time Frame: 9 DAYS ]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
- Change to bodyweight of subjects when using AYMES PRAGUE [ Time Frame: 9 days ]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 [ Time Frame: 9 days ]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 [ Time Frame: 9 days ]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 [ Time Frame: 9 days ]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