Acceptability and Tolerance of New Oral Nutritional Supplement
Acceptability and Tolerance of New Oral Nutritional Supplement
To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary
 oral nutritional support compared with currently available alternatives.
TITLE EVALUATION OF TOLERANCE AND ACCEPTABILITY OF AYMES LONDON STUDY OBJECTIVES

 -  To evaluate tolerance and acceptability of AYMES LONDON in patients requiring
 supplementary oral nutritional support compared with currently available alternatives.

 -  To obtain data to support an ACBS submissions for AYMES LONDON (to allow for
 prescription in the community at NHS expense).

 STUDY DESIGN Interventional study. STUDY POPULATION 20 patients established on an oral
 nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day.
 Patients residing in community settings (e.g. own home, care home or community hospital)
 STUDY PRODUCTS AYMES LONDON Patients' current oral nutritional supplements STUDY GROUPS This
 is an observational study where the patient will act as their own control, there will be just
 one study group containing all patients STUDY OUTLINE Baseline: After recruitment patients
 will remain on their current oral nutritional supplement for 3 days, during which time
 baseline tolerance data will be recorded (number and consistency of bowel movements, daily,
 volume of ONS taken, any episodes of nausea, vomiting, burping, abdominal pain, bloating or
 diarrhoea). A three-day food diary will be kept to record total oral intake. Patients will
 also have anthropometric measurements carried out during this period (weight, height, body
 mass index (BMI)).

 Intervention Period : Patients will then be changed onto an equivalent prescription of AYMES
 LONDON for a period of 9 days. Tolerance data will be recorded daily but the first 2 days on
 AYMES LONDON will be considered a 'transitional' period and data from these days will not be
 analysed. A further 3-day food diary will be kept during the intervention period. Weight of
 the patient will be recorded at the end of the period on AYMES LONDON, and an acceptability
 questionnaire will be completed.

 Comparisons will be made between baseline and the end of each phase of the study using
 appropriate analysis methods.
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 at least 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

 -  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 dysphagia requiring stage 1,2 or 3 thickened fluids

 -  Patients with uncontrolled inflammatory bowel disease or previous bowel resection with
 ongoing gastrointestinal symptoms.