NCT03913156

Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life

Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life: Acceptability and Efficacy of a New Protein Substitute

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

In this study the feeding patterns and practices at the introduction of a second stage phe-free protein substitute will be assessed in young children with PKU. This will be compared with the normal weaning process in healthy non-PKU age-matched children. In addition, tolerability and acceptability of the study product will be evaluated in a smaller group of subjects who have already been transferred onto a second stage protein substitute. The study is performed in 3 centers in the United Kingdom.

Detailed description

Part 1: For subjects with PKU, the study product will be incorporated in the diet as the second stage protein substitute until the subjects are 2 years of age. The healthy non-PKU age-matched subjects will not have the study product incorporated in their diet in order to be able to compare the weaning experience and nutritional intake of PKU subjects with non-PKU subjects. The healthy subjects will also be part of the study until the subjects are 2 years of age. Part 2: All PKU subjects will take the study product for 7 days.

Conditions

• PKU

Interventions

Type	Name	Description
OTHER	B2970 Metabolic Texture Modified Protein Substitute	The study product is a powdered phe-free protein substitute supplemented with long chain polyunsaturated fatty acids (LCP's), containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements and has been designed for use in the management of proven PKU in children aged 6 months to 5 years.

Timeline

• Start date: 2010-03-15
• Primary completion: 2013-04-01
• Completion: 2016-12-01
• First posted: 2019-04-12
• Last updated: 2020-06-19

Locations

3 sites across 1 country: United Kingdom