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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
51
Nutrient intake
Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.
Time frame: 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.
Time frame: 4 weeks (28 days)
Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)
Time frame: 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.
Time frame: 4 weeks (28 days)
Anthropometry
Changes to weight, height and head circumference in children less than 2yrs of age.
Time frame: 4 weeks (28 days)
Safety assessed by adverse events, to be recorded throughout study.
Time frame: 4 weeks (28 days)
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