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.

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.

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