To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition, taken either orally or via a feeding tube
To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support, either taken orally or with a feeding tube. Outcomes of GI effects, compliance, product preference, convenience etc. will be recorded. To obtain data to support an ACBS submission (to allow for prescription in the community at NHS expense).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
The Study product 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.
UCLH NHS Foundation Trust
London, United Kingdom
RECRUITINGAcceptability and Palatability of Oral Nutrition Supplement
To assess the acceptability of the shot-style protein supplement in patients requiring oral nutritional supplementation. On day 7 and 28 of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new oral nutrition supplement. A 5 point hedonic scale will be used.
Time frame: 28 days
Gastro-Intestinal (GI) Tolerance
To assess the GI tolerance of the shot-style protein supplement in patients with or at risk of disease related malnutrition, requiring additional protein, either fed orally or with a feeding tube. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days
Time frame: 7 days
Compliance
To assess the compliance of patients taking the Study product as prescribed. This is measured by daily completion of a compliance diary, comparing consumed amount versus prescribed amount.
Time frame: 28 days
Safety of consumption of Study Product
Daily assessment of GI symptoms
Time frame: 7 days
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