PKU UP is a prospective, single-arm, open-label, 26-week acceptability study to evaluate PKU UP for the dietary management of participants with phenylketonuria (PKU). Up to 15 participants aged 1 - 10 years old will be recruited and it is anticipated the study will open in at least three sites in the United Kingdom (UK) to recruit the target number of participants in the required timeframe.
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Change in phe level between baseline and visit 3
Timeframe: 26 weeks
Change in tyrosine level between baseline and visit 3
Timeframe: 26 weeks
Change in PI impression of metabolic control
Timeframe: Week 0, week 6, week 12, week 26
Change in the growth of participants as measured by Height (length in under 2 years of age), Head circumference in under 2 years of age and Weight.
Timeframe: Week 0, week 12, week 26
Change in GI tolerance (participant)
Timeframe: Week 0, week 6, week 12, week 26
Change in PI impression of GI tolerance
Timeframe: Week 0, week 6, week 12, week 26
Change in compliance with study product consumption
Timeframe: Week 0, week 6, week 12, week 26
Change in PI impression of study product intake
Timeframe: Week 0, week 6, week 12, week 26
Change in product acceptability
Timeframe: Week 0, week 12, week 26
Change in dietary intake
Timeframe: Week 0, week 12, week 26
Change in nutritional biochemistry
Timeframe: Week 0, week 26