Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria
Not Applicable
Terminated
- Conditions
- Phenylketonurias
- Interventions
- Other: PHE-diet
- Registration Number
- NCT04210206
- Lead Sponsor
- Klaus Parhofer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diet PHE-diet -
- Primary Outcome Measures
Name Time Method Spatial working memory strategy index 8 weeks cognitive function; scores range from 4 to 28, with lower scores representing better outcome
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University Munich
🇩🇪Munich, Germany