Efficacy of a nutritional biscuit in malnutrition management
Research type
Research Study
Full title
A randomised controlled eight week trial to investigate the efficacy of a biscuit style oral nutritional supplement in the management of malnutrition in the elderly.
IRAS ID
113771
Contact name
Ruth Price
Contact email
Sponsor organisation
Ulster University
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The health risks and costs associated with malnutrition can be significantly reduced if symptoms are recognised early and treated effectively. Oral nutritional supplements (ONS) have been shown to increase nutrient intakes and maintain or improve nutritional status and functional outcomes in patients in a variety of settings. However despite this it is frequently reported that compliance to ONS, which are often milk based drinks, is poor. The aim of the present study is to assess the effectiveness of a new biscuit style nutritional supplement in the management of malnutrition.
The study is a randomised controlled eight-week intervention study. Suitable participants will be identified by registered dieticians as those living in care facilities, aged 65 years and over, currently requiring ONS and competent to give consent. Participants (n=80) will be stratified based on BMI, gender and time on ONS, and randomly assigned (Minim Randomisation Software) to either the biscuit ONS group (n=40) or to remain on their existing ONS prescribed as part of their standard care practice (n=40). Changes in anthropometry, functional status, nutritional intake and appetite, general health, gastrointestinal symptoms and biochemistry (correction of nutritional deficiency), as well as compliance and acceptability of ONS will be assessed between week 0 and week 8. Participants will also be visited mid-intervention (week 4) to ensure well-being and assess compliance.
This work is funded by Calerrific Ltd. and seeks to determine if the new biscuit style nutritional supplement could be used as an alternative to, or in conjunction with, existing ONS to improve compliance and aid the recovery of malnourished patients.REC name
HSC REC B
REC reference
14/NI/1036
Date of REC Opinion
9 Sep 2014
REC opinion
Further Information Favourable Opinion