Effects of Synergy on Nutrient Intake and Acceptability in Phenylketonuria (PKU)

Inclusion criteria

• PKU subjects identified by newborn screening and started low-Phe diet before 3 months of age
• PKU subjects (with or without current AAM use) with an increased Phe-tolerance/intake due to:

• Mild PKU phenotype
• BH4 treatment
• If treated with BH4, PKU subjects should be on a stable BH4 treatment for at least 26 consecutive weeks up to start test product intake
• Age≥12 years
• If subjects (irrespective whether BH4 users or mild PKU) use amino-acid mixture(s; AAM), then a maximum of 25 Protein Equivalents (PE) derived from the AAM per day applies and usage on a daily basis for at least 26 consecutive weeks up to Visit 1
• If subjects (irrespective whether BH4 users or mild PKU) use AAMs they should be capable and willing to substitute their current AAM(s; maximum of 25 PE per day) with one portion of the test product per day
• If subjects (irrespective whether BH4 users or mild PKU) use omega-3, antioxidant, and/or vitamin supplements, to stop usage of the supplements and be able and willing to substitute with the test product
• Willing and able to comply with study procedures
• Willing and able to provide informed consent (and assent in case of minors if required by local law/regulations)
• For women of childbearing potential: not to have the intention to become pregnant during the study

Exclusion criteria

• For women: Currently pregnant or lactating
• Current or prior use of the test product within six weeks prior to entry into the study
• Concurrent conditions (including renal failure and severe hepatic failure) and medication that could interfere with participation, outcome parameters or safety (as determined by Investigator)
• Psychotropic medication (i.e. medication affecting the nervous system) and inotropic medication
• Any condition creating high risk of poor compliance with study
• Participation in any other studies involving investigational or marketed products concomitantly or within six weeks prior to entry into the study. Except for studies related to Kuvan® (synthetic tetrahydrobiopterin (BH4)) without diagnostic, therapeutic or experimental intervention.