High vs Standard Energy Children's Drink Study

The Effect of Standard Versus High Energy Density, Low Volume Oral Nutritional Supplements in Children Requiring Nutritional Support - a Pilot Trial

This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.

Study Overview

• Status: Completed
• Conditions: Growth Failure
• Intervention / Treatment: Other: HE ONS; Other: SE ONS

Detailed Description

A four week, multi-centre, randomised controlled trial investigating the effects of a high energy density, low volume oral nutritional supplement versus standard energy density oral nutritional supplements in children aged 1-12yrs old requiring nutritional support. Fifty eligible children will be recruited and randomised to receive either the high energy density oral nutritional supplement or the standard energy density oral nutritional supplement for four weeks. The primary outcome is nutrient intake, with secondary outcomes of compliance, tolerance, acceptability, anthropometry and safety.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female
• Aged 1-12yrs
• Faltering growth and/or requiring oral nutritional supplements to meet nutritional requirements
• Expected to receive at least one bottle of the study product per day
• Able to take study products orally during the study period
• Written informed consent from parent/carer

Exclusion Criteria:

• Requirement for 100% of their nutrition via enteral tube and/or parenteral feeding.
• Children with major hepatic or renal dysfunction
• Children with galactosaemia or severe lactose intolerance
• Requirement for elemental or semi-elemental feeds
• Investigator concern around willingness/ability of child/parent/carer to comply with protocol requirements
• Participation in other studies within 2 weeks of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; The group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days)	Other: HE ONS; High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management
Active Comparator: Group B; The group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days)	Other: SE ONS; Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrient intake	Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.	4 weeks (28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance: Compliance with oral nutritional supplements in Group A and Group B; how much of the oral nutritional supplement is taken in comparison to the amount advised by the Dietitian.		4 weeks (28 days)
Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)		4 weeks (28 days)
Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc.		4 weeks (28 days)
Anthropometry	Changes to weight, height and head circumference in children less than 2yrs of age.	4 weeks (28 days)
Safety assessed by adverse events, to be recorded throughout study.		4 weeks (28 days)

Collaborators and Investigators

• Sponsor: Nutricia UK Ltd

Publications and helpful links

General Publications

• Hubbard GP, Fry C, Sorensen K, Casewell C, Collins L, Cunjamalay A, Simpson M, Wall A, Van Wyk E, Ward M, Hallowes S, Duggan H, Robison J, Gane H, Pope L, Clark J, Stratton RJ. Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial. Eur J Pediatr. 2020 Sep;179(9):1421-1430. doi: 10.1007/s00431-020-03620-9. Epub 2020 Mar 13.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Failure to Thrive
• Other Study ID Numbers: FC125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED