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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Cristina
Romani
c.romani@aston.ac.uk
Dr
Cristina
Romani
c.romani@aston.ac.uk
Metabolic disorders
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People with Phenylketonuria (PKU), develop cognitive problems and poor mental health unless the food they eat is strictly controlled. This is because PKU leads to dangerous increases in levels of the amino acid Phenylalanine (Phe) in the blood causing irreparable damage to certain brain structures.
This project aims to compare the short-term cognitive and emotional effects of resuming a previously abandoned treatment diet in adults with PKU. We want to see whether outcomes improve or remain stable as individuals resume their PKU diet and levels of Phe in the blood decrease. This is particularly important in PKU as many patients abandon their diet after adolescence, and we do not yet know what impact this may have on cognitive abilities. Diets are often resumed in adulthood, most commonly due to a desire to improve one's home/work life, or because a patient is intending to become pregnant. Showing that cognitive abilities improve after resuming a strict diet would show that maintaining/abandoning a diet in adulthood has implications for cognition.
Testing will be conducted using a battery of neuropsychological assessments of cognitive function and a number of standardised measures of well-being. Phe levels will be measured using a blood spot test, the same as those administered during patients' regular clinical visits. Tests will be conducted at three separate times: 1) when diet is not/loosely followed (Phe level > = 600 micromole/l); 2) > = 3 months after target Phe level of < 360 micromole/l has been reached; and 3) > = 6 months after Phe target has been reached.
Our objective is to compare cognitive outcomes and emotional well-being at different time points after diet resumption, to better understand the short-term effects of resuming the PKU diet on cognitive abilities and well-being. Relationship with current Phe levels will also be investigated using correlation analyses.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
- Any participant who was late-diagnosed or started treatment (i.e. low-Phe diet) later than 3 weeks after birth. - Any participant who has not previously abandoned their strict treatment diet. - Any participant whose current blood Phe levels are lower that 600 micromole/l. - Any participant with additional illnesses known to impact cognitive development. - Any participant who is not a fluent English speaker.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Aston University and funded by Nutricia Research Foundation .
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Read full details
for Trial ID: CPMS 42797
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