High vs Standard Energy Children's Drink Study

Not Applicable

Completed

• Conditions: Growth Failure
• Interventions: Other: HE ONS; Other: SE ONS

• Registration Number: NCT02419599
• Lead Sponsor: Nutricia UK Ltd

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Study Start: 2015-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	HE ONS	The group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days)
Group B	SE ONS	The group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)	4 weeks (28 days)
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)
Anthropometry	4 weeks (28 days)	Changes to weight, height and head circumference in children less than 2yrs of age.
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)
Safety assessed by adverse events, to be recorded throughout study.	4 weeks (28 days)