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| Name | Class |
|---|---|
| Alison Clark Health and Nutrition | OTHER |
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To evaluate tolerance and acceptability of AYMES ROME 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 ROME (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 Rome for a period of 9 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AYMES ROME | Dietary Supplement | AYMES Rome is a powder, designed to be mixed with 250 ml water to make up a juice style ONS. When made up AYMES Rome provides 300 kcal (1 kcal / ml) and 10.7 g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision. |
| Measure | Description | Time Frame |
|---|---|---|
| GI side effects when using AYMES Rome | Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES Rome 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 Rome | 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 Rome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Clarke, BSc (Hons) | Alison Clark Health and Nutrition | Principal Investigator |
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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 Rome 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 Rome |
| 9 days |
| Bowel habits of subjects when using AYMES Rome - frequency | Recording of bowel habits whilst subjects consuming AYMES Rome, 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 Rome - stool consistency | Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period | 9 days |