Tolerance and Acceptability Evaluation AYMES Cardiff
Research type
Research Study
Full title
Tolerance and Acceptability Evaluation AYMES Cardiff
IRAS ID
273331
Contact name
Gemma Fry
Contact email
Sponsor organisation
AYMES International Ltd
Duration of Study in the UK
0 years, 3 months, 0 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 Cardiff (a milk-shake 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, patients will remain on their current ONS for 3 days (if applicable,) during which time relevant medical and a 24-hour dietary recall, along with baseline GI tolerance data will be recorded. Patients’ height and weight will be measured and BMI calculated at the start of the study.
Patients will then change to AYMES ‘Cardiff’ for a period of 30 days in the intervention period. During days 4-10 the patient/carer will continue to record tolerance data (as above) daily. A 24-hour dietary recall will be recorded on 10. On days 10 and 33, body weight will be measured and an acceptability and preference questionnaire will also be completed by patients. Compliance data (how much of the supplement was taken) will be recorded throughout the duration of the intervention period (30 days.)
AYMES International Ltd. will fund this research. The ONS is a Food for Special Medical Purposes and MHRA exempt.
REC name
Wales REC 7
REC reference
19/WA/0322
Date of REC Opinion
6 Nov 2019
REC opinion
Further Information Favourable Opinion