Acceptability & tolerance of 2 paediatric oral nutritional supplements
Research type
Research Study
Full title
Market research - a retrial to investigate the acceptability and tolerance of two new paediatric oral nutritional supplements:\n\nNualtra Altrini Shake 44g\nNualtra Altrini Compact Fibre 125ml
IRAS ID
289222
Contact name
Carolyn Patchell
Contact email
Sponsor organisation
Nualtra Ltd
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 3 months, 13 days
Research summary
Disease related malnutrition can be a consequence of many conditions and diseases. It can affect all age groups. Poor appetite and intake of food and liquids as a result of illness or treatment of those illnesses can lead to weight loss or poor growth in peadiatric patients. Oral nutritional supplements are a core part of the treatment and management of disease related malnutrition. \n\nAltrini Shake 44g and Altrini Compact Fibre 125ml are 2 new oral nutritional supplements for use in children aged 1 to 14 years. The aim of this trial to ensure they are palatable and tolerated by children within this age range who have or who are at risk of disease related malnutrition. \n\nThis trial seeks to ascertain whether they are palatable for patients, and whether they are tolerated by patients, for example, whether there are any side effects such as vomiting, tummy aches or diarrhoea (these are common side effects in\nalready Advisory Committee on Borderline Substances (ACBS) approved products of this nature) \n\nThe outcome of this market research will be included in our application to the ACBS in order to gain approval for us on prescription. An acceptability trial is obligatory for the ACBS application. The results of this trial will not be published or used in any medical texts. \n\nSubjects will be asked to take the new product for 7 days. During this time parents/caregivers or the patient (where appropriate) will be asked to complete a daily questionnaire recording information on:\n\n• Volume of product taken\n• Any gastrointestinal side-effects\n\nA questionnaire will also be completed at the beginning and end of the study that will consider perceptions about taste, appearance, smell, presentation and packaging of the product; ease of administration; and any other problems or symptoms.\n\nThe questionnaires should take a maximum of 30 minutes to complete.
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0129
Date of REC Opinion
12 Nov 2020
REC opinion
Further Information Favourable Opinion