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Completed

NCT Number: NCT05096988

Evaluation of PKU Sphere Liquid

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.

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Key information

Conditions

Phenylketonurias Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Hospital, Belfast, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of PKU requiring a low protein diet and protein substitute.
  • Aged three (3) years and over
  • Already taking a minimum of one GMP based protein substitute per day or have previously taken one
  • Able to comply with the study protocol and take the study product, according to the opinion of the PI.
  • Willingly given, written, informed consent from patient or parent/guardian.
  • Willingly given, written assent (if appropriate).

Exclusion criteria

  • Inability to comply with the study protocol, in the opinion of the investigator.
  • Any co-morbidity, which, in the opinion of the investigator, would preclude participation in the study.
  • Diagnosis of persistent hyperphenylalaninaemia, or mild PKU not requiring dietary intervention with a low protein diet and protein supplement.
  • Unwilling/unable to take a GMP based protein substitute.
  • Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.

N.B.: Women who become pregnant unexpectedly during this study will be immediately withdrawn from the study.

Treatment and study plan

PKU sphere liquid

Dietary Supplement

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

Primary outcomes

  1. Questionnaire of self-reported adherence to the prescribed amount of study product

    Time frame: 4 weeks

    Assessment of participant's adherence to prescribed amount during the eight week intake of the study product

  2. Product acceptability rated on a Likert scale by the participant after four week intake

    Time frame: 4 weeks

    Assessment of participant's acceptability following four week intake of the study product Scale is from 1 to 5: 1 = Loved it, 5 = Really didn't like it

  3. Questionnaire of self-reported changes in gastrointestinal tolerance during four week intake

    Time frame: 4 weeks

    Assessment of participant's gastrointestinal tolerance during the four week intake of the study product

Sponsors and collaborators

Lead sponsor

Vitaflo International, Ltd

Industry

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 27, 2021
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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