Acceptability and Tolerance Study of a New Oral Nutritional Supplement (ONS)
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|ClinicalTrials.gov Identifier: NCT02898038|
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Dietary Supplement: AYMES PARIS||Not Applicable|
To evaluate tolerance and acceptability of AYMES PARIS 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 PARIS (to allow for prescription in the community at NHS expense).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tolerance and Acceptability of AYMES PARIS|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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 PARIS for a period of 9 days.
Dietary Supplement: AYMES PARIS
AYMES PARIS is a powdered, high energy, oral nutritional supplement to be mixed with milk as a drink. It provides 320 kcal and 12.2 g protein per 139 ml 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 PARIS [ Time Frame: 9 DAYS ]Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES PARIS as assessed by presence / absence of side effect compared to baseline period
- Change to bodyweight of subjects when using AYMES PARIS [ 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 PARIS [ Time Frame: 9 DAYS ]Recording of amount of AYMES PARIS 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 PARIS
- Bowel habits of subjects when using AYMES PARIS - frequency [ Time Frame: 9 days ]Recording of bowel habits whilst subjects consuming AYMES PARIS, 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 PARIS - stool consistency [ Time Frame: 9 days ]Recording of bowel habits whilst subjects consuming AYMES PARIS, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period