NCT02419599

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Nutricia UK Ltd · Industry
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Failure

Interventions

Type	Name	Description
OTHER	HE ONS	High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management
OTHER	SE ONS	Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-04-17
• Last updated: 2017-11-01