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

December 8, 2023 updated by: Klaus Parhofer

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Munich, Germany, 81377
        • University Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Diet
Other: PHE-diet
phenylalanine-restricted diet with phenylalanine free supplements for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klaus Parhofer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoFu-PKU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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