Efficacy of a Nutrition Biscuit in Malnutrition Management

Not Applicable

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Biscuit style oral nutritional supplement

• Registration Number: NCT03118089
• Lead Sponsor: University of Ulster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-12
• Last Update Submitted: 2017-04-12
• Study First Posted: 2017-04-18
• Last Update Posted: 2017-04-18
• Primary Completion: 2017-10-30
• Study Completion: 2017-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biscuit style oral nutritional supplement treatment	Biscuit style oral nutritional supplement	Participants will take the biscuit style oral nutritional supplement at an intervention level equivalent to their current oral nutritional supplement prescription

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
General appetite	Change over 8 weeks from baseline	Likert scale assessment
Gastrointestinal tolerance	Change over 8 weeks from baseline	Likert scale assessment
Muscle strength	Change over 8 weeks from baseline	Hand grip strength
Food intake	Change over 8 weeks from baseline	24-hour dietary recall
Compliance	Change over 8 weeks from baseline	Self-reported diary
Serum electrolytes	Change over 4 weeks from baseline
Biscuit palatability	Change over 8 weeks from baseline	Likert scale assessment

Trial Locations

Locations (1)

Northern Health and Social Care Trust; 🇬🇧 Londonderry, Co.Londonderry, United Kingdom