TOLERANCE AND ACCEPTABILITY OF AYMES STOCKHOLM
Research type
Research Study
Full title
Evaluation of the Tolerance and Acceptability of AYMES STOCKHOLM
IRAS ID
244653
Contact name
Carole Springett
Contact email
Sponsor organisation
AYMES International Ltd.
Duration of Study in the UK
0 years, 1 months, 7 days
Research summary
The purpose of the study is to investigate the tolerance (bowel movements / gastro-intestinal (GI) side effects) and acceptability (sensory qualities / volume consumed) of AYMES STOCKHOLM (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 children aged 3 - 18 years, already established on an ONS, requiring nutritional supplementation of approximately 300 kcal per day or more. Patients suitable will be those residing in community settings.
Recruitment - lead investigator approaches patients in Outpatient Department at Sunderland Hospital, and discusses with the parents/guardians as to whether they wish to be included in the study.
With assent/consent taken, participants remain on current ONS for 3 days, and relevant medical and diet information is recorded. Baseline GI tolerance and bowel movement data are recorded, as is volume of ONS consumed (compliance). One 3-day food diary is completed. Participants' height and weight are measured and percentile documented, or body mass index (BMI), where relevant, is calculated on day 1.
Participants change to an equivalent prescription of AYMES STOCKHOLM ONS for nine 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 data. One 3-day food diary is kept during this period. Bodyweight is measured on day 12. An acceptability and preference questionnaire is completed by participants.REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0486
Date of REC Opinion
13 Jul 2018
REC opinion
Favourable Opinion