Acceptability and Tolerance Study of New Oral Nutritional Supplement
- Conditions
- Malnutrition
- Interventions
- Dietary Supplement: AYMES ROME
- Registration Number
- NCT02648451
- Lead Sponsor
- Aymes International Limited
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description intervention AYMES ROME 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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 - 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