Efficacy of a Nutrition Biscuit in Malnutrition Management

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 Overview

• Status: Unknown
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Biscuit style oral nutritional supplement

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Co.Londonderry
    • Londonderry, Co.Londonderry, United Kingdom
      • Northern Health and Social Care Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biscuit style oral nutritional supplement treatment; Participants will take the biscuit style oral nutritional supplement at an intervention level equivalent to their current oral nutritional supplement prescription	Dietary supplement: Biscuit style oral nutritional supplement
No Intervention: Standard Care; Participants will remain on their current oral nutritional supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	2% gain in 8 weeks where BMI<20kg/m2; prevention of further weight loss where BMI>20kg/m2	Change over 8 weeks from baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Ulster

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Anticipated): October 30, 2017
• Study Completion (Anticipated): October 30, 2017

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Oral nutritional supplements
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 13/NI/1036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No