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Clinical Trial Summary

A prospective, open-label study of PKU Sphere in patients with PKU following a phenylalanine restricted therapeutic diet.


Clinical Trial Description

The rationale for this study is to assess acceptability, adherence and metabolic control in individuals with PKU consuming PKU Sphere, a GMP-based medical food. The sponsor developed PKU Sphere in response to growing interest in GMP medical foods for the purpose of improving adherence and quality of life by offering an alternative to amino acid based medical foods. PKU Sphere is a powdered, low phenylalanine medical food containing a balanced mix of casein glycomacropeptide (GMP) isolate, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and the long chain polyunsaturated fatty acid (LCP); docosahexaenoic acid (DHA). PKU Sphere has been designed for use in the dietary management of Phenylketonuria. It is available in two flavors, Red Berry and Vanilla, packaged in individual serving sachets of 35g and containing 20g protein equivalent (PE). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03419819
Study type Interventional
Source Vitaflo International, Ltd
Contact
Status Completed
Phase N/A
Start date May 1, 2018
Completion date May 21, 2019

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