High vs Standard Energy Children's Drink Study

NCT02419599 | Completed

• 1 other identifier: FC125
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Growth Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  4 weeks (28 days)

• Safety assessed by adverse events, to be recorded throughout study.

  4 weeks (28 days)

Study Arms (2)

Group A

EXPERIMENTAL

The group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days)

Other: HE ONS

Group B

ACTIVE COMPARATOR

The group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days)

Other: SE ONS

Interventions

HE ONS OTHER

High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management

Group A

SE ONS OTHER

Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management

Group B

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Related Publications (1)

• Hubbard GP, Fry C, Sorensen K, Casewell C, Collins L, Cunjamalay A, Simpson M, Wall A, Van Wyk E, Ward M, Hallowes S, Duggan H, Robison J, Gane H, Pope L, Clark J, Stratton RJ. Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial. Eur J Pediatr. 2020 Sep;179(9):1421-1430. doi: 10.1007/s00431-020-03620-9. Epub 2020 Mar 13.

  PMID: 32170451 DERIVED

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 1, 2017

Record last verified: 2017-10