Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria

Kurzfristiger Einfluss Einer Guten Stoffwechseleinstellung Auf Kognitive Funktion, Wohlbefinden Und Stoffwechselparameter Bei Erwachsenen Patienten Mit Phenylketonurie (Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04210206

Enrollment

Registered

2019-12-24

Start date

2019-12-01

Completion date

2023-08-31

Last updated

2023-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phenylketonurias

Keywords

cognitive function adults

Brief summary

The goal of this study is to evaluate if in adult patients with phenylketonuria (PKU) without strict metabolic control during the last 12 months, strict metabolic control for 8 weeks results in an improvement of cognitive function.

Interventions

OTHERPHE-diet

phenylalanine-restricted diet with phenylalanine free supplements for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Inclusion criteria

* Men and women with classical PKU * Age ≥ 18 years * Good metabolic control during childhood (at least until 12 years of age) * Plasma Phe levels ≥ 15 mg/dl for ≥ 1 year * Written informed consent prior to study participation

Exclusion criteria

* Reduced cognitive function (unability to perform test battery) * Drug and or alcohol abuse * Treatment with BH4 * Treatment with drugs known to affect cognitive function

Design outcomes

Primary

Measure	Time frame	Description
Spatial working memory strategy index	8 weeks	cognitive function; scores range from 4 to 28, with lower scores representing better outcome

Secondary

Measure	Time frame	Description
Reaction time	8 weeks	cognitive function; milliseconds, with faster times representing better outcome
Paired Associates Learning	8 weeks	cognitive function; scores range from 0 to 70, with lower scores indicating better outcome
Multitasking Test	8 weeks	cognitive function; scores range from 0 to 279, with lower scores indicating better outcome

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026