The health risks and costs associated with malnutrition can be significantly reduced if symptoms are recognized 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 randomized controlled eight-week intervention study. Suitable participants currently being prescribed ONS and who meet the study inclusion and exclusion criteria, will be identified by either staff in care facilities, Registered Dietitians or by General Practitioner (GP) surgeries. Participants (n=80) will be stratified based on BMI and gender and randomly assigned 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Northern Health and Social Care Trust
Londonderry, Co.Londonderry, United Kingdom
Weight change
2% gain in 8 weeks where BMI\<20kg/m2; prevention of further weight loss where BMI\>20kg/m2
Time frame: Change over 8 weeks from baseline
Muscle strength
Hand grip strength
Time frame: Change over 8 weeks from baseline
Food intake
24-hour dietary recall
Time frame: Change over 8 weeks from baseline
General appetite
Likert scale assessment
Time frame: Change over 8 weeks from baseline
Gastrointestinal tolerance
Likert scale assessment
Time frame: Change over 8 weeks from baseline
Serum electrolytes
Time frame: Change over 4 weeks from baseline
Biscuit palatability
Likert scale assessment
Time frame: Change over 8 weeks from baseline
Compliance
Self-reported diary
Time frame: Change over 8 weeks from baseline
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