Efficacy of a Nutrition Biscuit in Malnutrition Management

Study Overview
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Brief Summary
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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.

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Biscuit style oral nutritional supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biscuit style oral nutritional supplement treatment<br>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<br> <br> |
| No Intervention: Standard Care<br>Participants will remain on their current oral nutritional supplement | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutritional supplements