NCT05096988

Evaluation of PKU Sphere Liquid

A Study to Evaluate the Acceptability, Tolerance and Adherence of Children and Adults Consuming PKU Sphere Liquid, a Food for Special Medical Purposes (FSMP), for the Dietary Management of Phenylketonuria (PKU)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Vitaflo International, Ltd · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

PKU Sphere Liquid is a prospective, open-label, acceptability study to evaluate PKU sphere liquid in up to 15 participants aged 3 and above for the dietary management of PKU over 31 days.

Detailed description

PKU Sphere Liquid is a newly-developed Food for Special Medical Purposes (FSMP) designed for the dietary management of patients with phenylketonuria (PKU). PKU sphere liquid is a vanilla flavoured, ready-to-drink, low phenylalanine protein substitute containing a blend of casein glycomacropeptide (GMP) isolate, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, and Docosachexaenoic acid (DHA). This is a feasibility study designed to evaluate the acceptability, tolerance and adherence of children and adults consuming PKU sphere liquid. Participants will be given a four-week supply of PKU Sphere Liquid and they will be asked to complete a daily diary and short questionnaire for four weeks to record information on: adherence, gastrointestinal tolerance, palatability and how the product is used. Each participant will be on the trial for 31 days. This includes a 3-day baseline period and 28 days taking the study product. If deemed appropriate in each individual circumstance, the sponsor of the trial, Vitaflo International Ltd, will continue to supply the product free of charge at the end of the trial until available on prescription.

Conditions

• Phenylketonurias

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PKU sphere liquid	PKU sphere liquid will be prescribed by the study dietitian based on the patient's individual requirements.

Timeline

• Start date: 2021-11-23
• Primary completion: 2022-06-21
• Completion: 2023-02-28
• First posted: 2021-10-27
• Last updated: 2024-02-16

Locations

3 sites across 1 country: United Kingdom