AYMES Shake Plus Thickener Tolerance and Acceptability Study
Research type
Research Study
Full title
AYMES Shake Plus Thickener Tolerance and Acceptability Study
IRAS ID
177481
Contact name
Roger Wertheim-Aymes
Contact email
Sponsor organisation
AYMES International Ltd
Duration of Study in the UK
0 years, 0 months, 14 days
Research summary
Is AYMES Shake Plus Thickener acceptable and tolerated by participants requiring oral nutritional supplements (ONS) to improve their nutritional status?
Oral nutritional support may be essential for people who are unable to meet their nutritional needs solely from food and fluids. This is particularly the case for those who are in nursing/residential care, requiring encouragement with meals or on a fortified diet.
AYMES Shake Plus Thickener is an ONS that can be made up as needed to meet the nutritional needs of patients in a community setting. In order to increase the variety of supplements available, AYMES International Ltd has developed a new ONS product that now requires tolerability and acceptability testing. The product is presented as a powder that is then mixed with milk to produce a nutritionally-dense 'dessert-style’ ONS. The aim of this study is to test the acceptability of this product looking at weight changes, volume taken, tolerance and participants’ views.
Ideally 20 residents of UK-based, non-NHS, nursing/residential homes who require additional oral nutritional support through ONS will be recruited to the study. They will be monitored daily whilst they continue with their current ONS for 3 days (baseline) and then will be changed to AYMES Shake Plus Thickener for 2 days (transitional) and 7 days (intervention). Each participant will therefore be on the study for 14 days.
Therefore between days 4-12, participants will receive AYMES instead of their usual prescribed ONS at each prescription time. E.g. If a participant was previously on Fortisip Compact, twice a day at 08:00 and 17:00 their trial prescription would become AYMES Shake Plus Thickener, twice a day, at 08:00 and 17:00. The ONS is always given by trained staff.This study is being carried out by the Dietitians and Health Care Professionals and sponsored by AYMES International Ltd.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0131
Date of REC Opinion
10 Jul 2015
REC opinion
Further Information Favourable Opinion