Tolerance and Acceptability of AYMES ATHENS
Research type
Research Study
Full title
Evaluation of the Tolerance and Acceptability of AYMES ATHENS
IRAS ID
251731
Contact name
Lucie Nield
Contact email
Sponsor organisation
AYMES
Duration of Study in the UK
0 years, 1 months, 24 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 ATHENS (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 Health Service Executive (HSE). The HSE is the governing body that makes the decision whether or not an ONS can be prescribed in the community in Ireland.
The study will be carried out with adults over the age of 18 years that are already established on an ONS, requiring nutritional supplementation of at least 300kcal/day. Patients suitable will be those residing in community settings.
Following recruitment to the study, patients will remain on their current ONS for 3 days, during which time relevant medical and a three-day dietary history, 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 a prescription of AYMES ‘ATHENS’ for a period of 27 days in the intervention period. During days 4-30 the patient/carer will continue to record tolerance data (as above) daily, along with compliance data (how much of the supplement was taken.) A three-day food diary will also be kept during the intervention period. Body weight will be measured on day 6 and 30 and an acceptability and preference questionnaire will be completed by patients.
AYMES International Ltd. will fund this research. The ONS is a Food for Special Medical Purposes and MHRA exempt.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0764
Date of REC Opinion
4 Dec 2018
REC opinion
Further Information Favourable Opinion