Efficacy of a Nutrition Biscuit in Malnutrition Management

NCT03118089 | Unknown

• 1 other identifier: 13/NI/1036
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Oral nutritional supplements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Muscle strength

  Change over 8 weeks from baseline

• Food intake

  Change over 8 weeks from baseline

• General appetite

  Change over 8 weeks from baseline

• Gastrointestinal tolerance

  Change over 8 weeks from baseline

• Serum electrolytes

  Change over 4 weeks from baseline

Study Arms (2)

Biscuit style oral nutritional supplement treatment

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Participants will remain on their current oral nutritional supplement

Interventions

Biscuit style oral nutritional supplement DIETARY_SUPPLEMENT

Biscuit style oral nutritional supplement treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently requiring oral nutritional supplement (minimum 8 weeks)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

Northern Health and Social Care Trust

Londonderry, Co.Londonderry, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 18, 2017
• Study Start: September 1, 2014
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)