High vs Standard Energy Children's Drink Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Growth Failure

Intervention / Treatment
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* Other: HE ONS
* Other: SE ONS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |