Clinical trial NCT03118089: Efficacy of a Nutrition Biscuit in Malnutrition Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Keywords: Oral nutritional supplements
Lead sponsor: University of Ulster
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight change
timeFrame: Change over 8 weeks from baseline
Secondary outcomes:
measure: Muscle strength
timeFrame: Change over 8 weeks from baseline
measure: Food intake
timeFrame: Change over 8 weeks from baseline
measure: General appetite
timeFrame: Change over 8 weeks from baseline
measure: Gastrointestinal tolerance
timeFrame: Change over 8 weeks from baseline
measure: Serum electrolytes
timeFrame: Change over 4 weeks from baseline
measure: Biscuit palatability
timeFrame: Change over 8 weeks from baseline
measure: Compliance
timeFrame: Change over 8 weeks from baseline
Other outcomes:
Locations:
city: Londonderry
country: United Kingdom
facility: Northern Health and Social Care Trust
state: Co.Londonderry
Study officials:
References: