Acceptability Evaluation of AYMES Protein Shot
Research type
Research Study
Full title
Tolerance and Acceptability Evaluation of AYMES Protein Shot
IRAS ID
301521
Contact name
Maryann McLees
Contact email
Sponsor organisation
AYMES International Ltd.
Duration of Study in the UK
0 years, 5 months, 6 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 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) and Health Service Executive (HSE). Both the ACBS and HSE 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 study will be carried out with adults over the age of 18 years that require nutritional supplementation. Following recruitment to the study, participants will remain on their current ONS for 3 days (if applicable) during which time relevant medical/nutritional information will be recorded, along with baseline GI tolerance data will be recorded. 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 AYMES Protein Shot for a period of 28 days in the intervention period. GI tolerance will be recorded daily whilst body weight, hand grip strength and sit to stand time, alongside an acceptability and preference questionnaire will be completed on day 31. Compliance data (how much of the supplement was taken) will be recorded throughout the duration of the intervention period (28 days).
AYMES International Ltd. will fund this research. The ONS is a Food for Special Medical Purposes and MHRA exempt.REC name
London - Bloomsbury Research Ethics Committee
REC reference
21/LO/0803
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Unfavourable Opinion