University of Guelph
Guelph, Ontario, N1G 2W1, Canada
NCT Number: NCT05958784
This is a clinical intervention pilot/feasibility study of PKU carriers (cases) and non-carriers (controls). Upon completing the informed consent process, participants will complete baseline measures of chronic mental health prior to the intervention (PHQ-9, GAD-7, BIS-Brief). Participants will attend the Human Nutraceutical Research Unit (HNRU) at the University of Guelph, fasted, and first undergo baseline measures of cognition and acute mental health (mood) and provide samples or saliva, urine and dried blood spots to evaluate phenylalanine (Phe), tyrosine (Tyr) and their metabolites (PAH pathway functioning). Participants will also complete a brief questionnaire which will include age, sex, ethnicity, income, weight and height (measured using a stadiometer and calibrated weigh scale), and confirmation that participants arrived to the lab fasted (i.e. have only had water to drink and no other foods/beverages prior to analyses). Blood pressure will also be measured at baseline. Following baseline tests, participants will consume a pure L-Phe supplement dosed at 100 mg/kg mixed into 250 mL water with 1 tsp white sugar. Blood pressure will be repeated at 1-hour post-L-Phe consumption. Two-hours postprandial, participants will repeat the cognitive tests and acute mental health (mood) assessment, blood pressure measurement and provide follow-up saliva, urine and dried blood spot samples. Participants will also be asked to report any side effects they experienced with the L-Phe consumption.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Guelph, Ontario, N1G 2W1, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100 mg/kg
Time frame: Change from baseline to 2-hours post L-Phe supplementation
Time frame: Change from baseline to 2-hours post L-Phe supplementation
N-Back Test Outcome
Time frame: Change from baseline to 2-hours post L-Phe supplementation
Stop Signal Task Outcome
Time frame: Change from baseline to 2-hours post L-Phe supplementation
Stop Signal Task Outcome
Time frame: Change from baseline to 2-hours post L-Phe supplementation
Time frame: Change from baseline to 2-hours post L-Phe supplementation
Time frame: Change from baseline to 2-hours post L-Phe supplementation
Time frame: Change from baseline to 2-hours post L-Phe supplementation
Time frame: Change from baseline to 2-hours post L-Phe supplementation
Profile of Mood States (POMS) Outcome
Time frame: Change from baseline to 1-hour and 2-hours post L-Phe supplementation
Systolic and Diastolic
Time frame: Baseline
GAD-7 Outcome
Time frame: Baseline
PHQ-9 Outcome
Time frame: Baseline
BIS-Brief Outcome
Time frame: Change from baseline to 2-hours post L-Phe supplementation
To be conducted if there are significant findings from the four main stop signal task outcomes
University of Guelph
Other
A Pilot Study for the PKU Carriers Trial: Evaluating the Impact of PKU Carrier Status on Cognition, Mental Health, Blood Pressure and L-phenylalanine Metabolism
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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