Efficacy of a Nutrition Biscuit in Malnutrition Management

NCT ID: NCT03118089

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2017-10-30

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.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Biscuit style oral nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

Standard Care

Participants will remain on their current oral nutritional supplement

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Biscuit style oral nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northern Health and Social Care Trust

Londonderry, Co.Londonderry, United Kingdom

Countries

United Kingdom

Other Identifiers

13/NI/1036

Identifier Type: -

Identifier Source: org_study_id