Malnutrition
Conditions
Keywords
Oral nutritional supplements
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTBiscuit style oral nutritional supplement
Sponsors
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently requiring oral nutritional supplement (minimum 8 weeks)
Exclusion criteria
* Requiring tube or parenteral nutrition, texture modification or specialised diet * Diagnosed chronic renal or liver disease, diabetes T1, cancer cachexia * Any other condition whereby taking part in the study may have a negative impact on well-being
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | Change over 8 weeks from baseline | 2% gain in 8 weeks where BMI\<20kg/m2; prevention of further weight loss where BMI\>20kg/m2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | Change over 8 weeks from baseline | Hand grip strength |
| Food intake | Change over 8 weeks from baseline | 24-hour dietary recall |
| General appetite | Change over 8 weeks from baseline | Likert scale assessment |
| Gastrointestinal tolerance | Change over 8 weeks from baseline | Likert scale assessment |
| Serum electrolytes | Change over 4 weeks from baseline | — |
| Biscuit palatability | Change over 8 weeks from baseline | Likert scale assessment |
| Compliance | Change over 8 weeks from baseline | Self-reported diary |
Countries
United Kingdom
Outcome results
None listed