The Diet for Life study.
Recruiting
- Conditions
- 1. PKU<br />2. Phenylalanine<br />3. Diet<br />4. Neuropsychological function<br />5. Wellbeing.
- Registration Number
- NL-OMON23483
- Lead Sponsor
- AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Patients with PKU aged 18 and older who have been detected by newborn screening and have been continuously treated with a protein restricted diet and supplementation of aminoacids.
Exclusion Criteria
Poor dietary adherence with a mean phe value above 1100 umol/l in the year prior to the start of the study
Pregnancy or the wish to conceive within 3 months after the end of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The neuropsychological deficit profile of adults with treated PKU. <br /><br>1. What are the relative strengths and weaknesses in the neurocognitive functioning of adults with treated PKU?;<br /><br>2. Does supplementation of Phe to plasma levels comparable to levels observed in adult patients who fully discontinued their diet, influence neurocognitive functioning, and/or other disease parameters?<br>
- Secondary Outcome Measures
Name Time Method The neurophysiological mechanisms responsible for neuropsychological dysfunction in adults with treated PKU.<br /><br>1. Can abnormal functional networks be demonstrated in adults with treated PKU?;<br /> <br>2. Is network disruption more severe following the intervention-related increase in phenylalanine level?;<br /><br>3. Is there a correlation between the nature and severity of neuropsychological dysfunction in adults with treated PKU and the nature and severity of network disruption in these subjects?<br>