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| Name | Class |
|---|---|
| Eat Well Now | UNKNOWN |
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Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AYMES PRAGUE | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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 |