TOLERANCE AND ACCEPTABILTY EVALUATION OF AYMES ‘BERLIN’
Research type
Research Study
Full title
TOLERANCE AND ACCEPTABILTY EVALUATION OF AYMES ‘BERLIN’
IRAS ID
212195
Contact name
DEBRA WILLIAMS
Contact email
Duration of Study in the UK
0 years, 0 months, 15 days
Research summary
The purpose of this study is to investigate the tolerance and acceptability of AYMES BERLIN (oral nutritional supplement ONS) in patients requiring supplementary oral nutritional support compared with currently available alternatives. It is of relevance to patients and the general public because it provides data which can be submitted to the ACBS (Advisory Committee on Borderline Substances). The ACBS is the governing body that makes the decision whether the supplement can be prescribed in the community at NHS expense.
The study will be carried out with adults over the age of 18 years that are already established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day. Patients suitable will be those residing in community settings.
Following recruitment to the study, patients will remain on their current oral nutritional supplement for 3 days, during which time relevant medical and dietary history, along with baseline gastrointestinal tolerance data will be recorded. A three-day food diary will be kept to record total oral intake. Patients’ height and weight will be measured and BMI calculated at the start of the study.Patients will then change to a prescription of AYMES ‘BERLIN’ for a period of 9 days in the intervention period , with the first 2 days considered a “transitional” period where data will be recorded but not analysed. During days 6-12 the carer will continue to record tolerance data (as above) daily, along with compliance (how much of the supplement was taken) data detailing AYMES ‘BERLIN’ intake. A three-day food diary will also be kept during the intervention period. Body weight will be measured on day 12 and an acceptability and preference questionnaire will be completed by patients. In addition, carers providing the trial supplement will complete an ease of use questionnaire.
REC name
London - Surrey Research Ethics Committee
REC reference
16/LO/1645
Date of REC Opinion
13 Oct 2016
REC opinion
Further Information Favourable Opinion