Evaluation of PKU Sphere

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT03419819
• Date of registration: 03/01/2018
• Prospective Registration: Yes
• Primary sponsor: Vitaflo International, Ltd
• Public title: Evaluation of PKU Sphere
• Scientific title: Evaluation of the Acceptability, Tolerance, and Satiety of PKU Sphere, a Glycomacropeptide (GMP) Based Medical Food in Patients With Phenylketonuria (PKU).
• Date of first enrolment: May 1, 2018
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03419819
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Joyanna Hansen, PhD
• Affiliation: Oregon Health and Science University

• Name: Sandra Van Calcar, PhD
• Affiliation: Oregon Health and Science University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of PKU, identified by newborn screening (NBS) and treated since birth.

- Ages 3 years and above (this includes pregnant women who will be assessed on an
individual basis by the Co-Principal Investigators).

- Currently or previously consuming a low phenylalanine diet supplemented with a medical
food designed for the dietary management of PKU.

- English as primary language.

- Willingly given, written, informed consent from the participant, 18 or more years, or
from the parent/caregiver for participants < 18 years.

- Willingly given, written assent (if appropriate) for those < 18 years.

Exclusion Criteria:

- Currently consuming 100% of the medical food component of the diet as PKU sphere.

- An inability, in the opinion of the investigator, to comply with the requirements of
the protocol.

- Any other type of inherited metabolic disease.



Age minimum: 3 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Phenylketonurias

Intervention(s)

Dietary Supplement: PKU Sphere

Primary Outcome(s)

Phase 2: questionnaire data captured to evaluate change in taste perception [Time Frame: Phase 2, days 14 and 28.]

Phase 2: tyrosine concentration [Time Frame: Twice weekly for four weeks during phase 2]

Phase 1: texture [Time Frame: Days 1 - 7.]

Phase 1: gastrointestinal tolerance [Time Frame: Days 1 - 7.]

Phase 1: phenylalanine concentration [Time Frame: Days 1 and 7.]

Phase 2: change in 3-day diet record at end of study [Time Frame: Phase 2, days 1 - 3 and days 26 - 28.]

Phase 2: questionnaire data captured to evaluate change in smell perception [Time Frame: Phase 2, days 14 and 28.]

Phase 2: phenylalanine concentration [Time Frame: Twice weekly for four weeks during phase 2]

Phase 2: quantitative change in plasma amino acids at day 28 [Time Frame: Phase 2, day 1 and day 28.]

Phase 1: smell [Time Frame: Days 1 - 7.]

Phase 1: taste [Time Frame: Days 1 - 7.]

Phase 2: change in anthropometry at end of study [Time Frame: Phase 2, days 1 and 28.]

Phase 2: gastrointestinal tolerance [Time Frame: Phase 2, days 1 - 28.]

Phase 1: tyrosine concentration [Time Frame: Days 1 and 7.]

Phase 2: questionnaire data captured to evaluate change in texture perception [Time Frame: Phase 2, days 14 and 28.]

Secondary Outcome(s)

Phase 2: questoinnaire evaluating subjective measures of satiety [Time Frame: Phase 2, days 1, 14 and 28.]

Phase 1: questoinnaire evaluating subjective measures of satiety [Time Frame: Phase 1, days 1 - 7.]

Secondary ID(s)

SCT-PKUS-2016-11-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oregon Health and Science University