Efficacy of a Nutrition Biscuit in Malnutrition Management

Malnutrition Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03118089
• Other study ID #: 13/NI/1036
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 7, 2017
• Last updated: April 12, 2017
• Start date: September 1, 2014
• Est. completion date: October 30, 2017

Study information

• Verified date: April 2017
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Biscuit style oral nutritional supplement

Locations

Country	Name	City	State
United Kingdom	Northern Health and Social Care Trust	Londonderry	Co.Londonderry

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

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