Efficacy of a Nutrition Biscuit in Malnutrition Management
Primary Purpose
Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Biscuit style oral nutritional supplement
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Oral nutritional supplements
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
Sites / Locations
- Northern Health and Social Care Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Biscuit style oral nutritional supplement treatment
Standard Care
Arm Description
Participants will take the biscuit style oral nutritional supplement at an intervention level equivalent to their current oral nutritional supplement prescription
Participants will remain on their current oral nutritional supplement
Outcomes
Primary Outcome Measures
Weight change
2% gain in 8 weeks where BMI<20kg/m2; prevention of further weight loss where BMI>20kg/m2
Secondary Outcome Measures
Muscle strength
Hand grip strength
Food intake
24-hour dietary recall
General appetite
Likert scale assessment
Gastrointestinal tolerance
Likert scale assessment
Serum electrolytes
Biscuit palatability
Likert scale assessment
Compliance
Self-reported diary
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03118089
Brief Title
Efficacy of a Nutrition Biscuit in Malnutrition Management
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
October 30, 2017 (Anticipated)
Study Completion Date
October 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Oral nutritional supplements
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biscuit style oral nutritional supplement treatment
Arm Type
Experimental
Arm Description
Participants will take the biscuit style oral nutritional supplement at an intervention level equivalent to their current oral nutritional supplement prescription
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Participants will remain on their current oral nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Biscuit style oral nutritional supplement
Primary Outcome Measure Information:
Title
Weight change
Description
2% gain in 8 weeks where BMI<20kg/m2; prevention of further weight loss where BMI>20kg/m2
Time Frame
Change over 8 weeks from baseline
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Hand grip strength
Time Frame
Change over 8 weeks from baseline
Title
Food intake
Description
24-hour dietary recall
Time Frame
Change over 8 weeks from baseline
Title
General appetite
Description
Likert scale assessment
Time Frame
Change over 8 weeks from baseline
Title
Gastrointestinal tolerance
Description
Likert scale assessment
Time Frame
Change over 8 weeks from baseline
Title
Serum electrolytes
Time Frame
Change over 4 weeks from baseline
Title
Biscuit palatability
Description
Likert scale assessment
Time Frame
Change over 8 weeks from baseline
Title
Compliance
Description
Self-reported diary
Time Frame
Change over 8 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northern Health and Social Care Trust
City
Londonderry
State/Province
Co.Londonderry
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of a Nutrition Biscuit in Malnutrition Management
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