Acceptability and Tolerance of AYMES SWIFT and AYMES SWIFT FIBRE
Research type
Research Study
Full title
Acceptability and Tolerance Evaluation of AYMES SWIFT and AYMES SWIFT FIBRE
IRAS ID
317139
Contact name
Alice Johnson
Contact email
Sponsor organisation
AYMES International Ltd.
Duration of Study in the UK
0 years, 3 months, 1 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 SWIFT and AYMES SWIFT FIBRE (a high energy and a high energy, high fibre oral nutritional supplement (ONS)) in patients requiring supplementary oral nutritional support.
It is of relevance to patients, healthcare professionals (HCP) and the general public as it provides the required data needed to be submitted to the Advisory Committee on Borderline Substances (ACBS) and Health Service Executive (HSE). Both the ACBS (UK DOH - reimbursement) and HSE (Ireland - reimbursement) are governing bodies that make the decision whether an ONS can be prescribed in the community in the UK and Ireland respectively.
The process is detailed at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/792998/Appendix5.pdf
The study will be carried out in participants ≥ 18 years of age that require nutritional supplementation who are able to consent. Following recruitment to the study, relevant medical/nutritional information will be recorded, along with baseline GI tolerance data. Participants height and weight will be measured, BMI calculated and hand grip strength measured at the start of the study.
Participants will then change to / start either AYMES SIFT or AYMES SWIFT FIBRE (product determined by investigating Dietitian) for a period of 28 days in the intervention period. GI tolerance will be recorded daily for the first 7 days and compliance data (how much of the supplement was taken) will be recorded throughout the duration of the intervention period (28 days). An acceptability and preference questionnaire will be completed on day 7. Body weight and hand grip strength alongside a repeated acceptability and preference questionnaire will be completed on day 28.
AYMES International Ltd. will fund this research. The ONS is a Food for Special Medical Purposes and MHRA exempt.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
22/YH/0174
Date of REC Opinion
25 Aug 2022
REC opinion
Favourable Opinion