Acceptability Evaluation of AYMES Protein Shot
Research type
Research Study
Full title
Tolerance and Acceptability Evaluation of AYMES Protein Shot
IRAS ID
309458
Contact name
Gemma Fry
Contact email
Sponsor organisation
AYMES International Ltd.
Duration of Study in the UK
0 years, 4 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 Protein Shot (a shot style oral nutritional supplement (ONS)) in patients requiring supplementary oral nutritional support.
It is of relevance to patients, health care 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 body's that make the decision whether or not 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
A copy of this has bee uploaded as part of this application.
The study will be carried out with adults over the age of 18 years 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 and BMI calculated at the start of the study. As well as hand grip strength and sit to stand time.
Participants will then change to / start AYMES Protein Shot 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, hand grip strength and sit to stand time, 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
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0045
Date of REC Opinion
14 Feb 2022
REC opinion
Further Information Favourable Opinion