TOLERANCE AND ACCEPTABILITY OF AYMES 'MONACO'
Research type
Research Study
Full title
Evaluation of the Tolerance and Acceptability of AYMES 'MONACO'
IRAS ID
234687
Contact name
Carole Springett
Contact email
Sponsor organisation
AYMES International Ltd
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
The purpose of this study is to investigate the tolerance (bowel movements / Gastro-Intestinal (GI) side effects) and acceptability (sensory qualities/volume) of AYMES MONACO (a high energy oral nutritional supplement (ONS)) in patients requiring supplementary oral nutritional support compared with currently available ONS. It is of relevance to patients, health care professionals (HCP) and the general public as it provides data which can be submitted to the Advisory Committee on Borderline Substances (ACBS). The ACBS is the governing body that makes the decision whether or not an ONS can be prescribed in the community at the expense of the NHS.
Participants will be adults over the age of 18 years, already established on an ONS, requiring nutritional supplementation of at least 400 kcal/day. Patients suitable will be those residing in community settings.
Recruitment is via lead investigator approaching residential schools to identify potential participants, followed by discussions with the pupils/guardians as to whether they wish to be included in the study.
With assent/consent taken, participants remain on current ONS for 3 days, during which time relevant medical and dietary history. Baseline GI tolerance and bowel movement data are recorded. A 3-day food diary is kept to record dietary intake. Participants' height and weight are measured and percentile documented or body mass index (BMI), where relevant, is calculated on day 1.
Participants change to the equivalent prescription of AYMES MONACO ONS for 9 days (intervention period), with days 4-5 considered a 'transitional' period where data will be recorded but not included in the analysis. Days 6-12 daily tolerance data (as above) will be recorded, along with compliance (how much of ONS was prescribed/taken). One 3 day food diary is kept during this period. Bodyweight is measured on day 12. Acceptability and preference questionnaire is completed by participants along with and ease of use questionnaire.REC name
London - Stanmore Research Ethics Committee
REC reference
17/LO/1691
Date of REC Opinion
21 Nov 2017
REC opinion
Further Information Favourable Opinion