Malnutrition
Conditions
Brief summary
* To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives. * To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTAYMES ROME
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.
Sponsors
Alison Clark Health and Nutrition
Aymes International Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) who are able to communicate their views regarding acceptability. * Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day * Patients expected to require oral nutritional supplementation for at least 2 further weeks. * Informed consent obtained.
Exclusion criteria
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study * Patients requiring a milk free diet * Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list) * Patients with significant renal or hepatic impairment * Patients with swallowing impairment requiring thickened fluids * Patients with inflammatory bowel disease or previous bowel resection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI side effects when using AYMES Rome | 9 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change to bodyweight of subjects when using AYMES Rome | 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 Rome | 9 days | 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 |
| Bowel habits of subjects when using AYMES Rome - frequency | 9 days | 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 |
| Bowel habits of subjects when using AYMES Rome - stool consistency | 9 days | 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 |
Outcome results
None listed