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| Name | Class |
|---|---|
| Alison Clark Health and Nutrition | OTHER |
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Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | 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 PARIS for a period of 9 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AYMES PARIS | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| GI side effects when using AYMES PARIS | 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 | 9 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| Change to bodyweight of subjects when using AYMES PARIS | 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 PARIS |
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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 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 |
| 9 DAYS |
| Bowel habits of subjects when using AYMES PARIS - frequency | 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 | 9 days |
| Bowel habits of subjects when using AYMES PARIS - stool consistency | 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 | 9 days |