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| Name | Class |
|---|---|
| McMaster University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genetic Carriers and Non-Carriers of PKU | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Phenylalanine | Dietary Supplement | 100 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stop Signal Reaction Time (Response Inhibition) | Change from baseline to 2-hours post L-Phe supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Working Memory | N-Back Test Outcome | Change from baseline to 2-hours post L-Phe supplementation |
| Stop Signal Delay | Stop Signal Task Outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Anxiety | GAD-7 Outcome | Baseline |
| Chronic Depression | PHQ-9 Outcome | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guelph | Guelph | Ontario | N1G 2W1 | Canada |
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| ID | Term |
|---|---|
| D010649 | Phenylalanine |
| ID | Term |
|---|---|
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Change from baseline to 2-hours post L-Phe supplementation |
| Individual Coefficient of Variance (Variability in Reaction Times) | Stop Signal Task Outcome | Change from baseline to 2-hours post L-Phe supplementation |
| Phenylalanine Levels | Change from baseline to 2-hours post L-Phe supplementation |
| Tyrosine Levels | Change from baseline to 2-hours post L-Phe supplementation |
| Phenylalanine Metabolites: e.g.phenylethylamine, tyramine, phenylpyruvate, others | Change from baseline to 2-hours post L-Phe supplementation |
| Tyrosine Metabolites: e.g. L-DOPA, dopamine, norepinephrine, epinephrine, p-hydroxyphenylpyruvate, homogentisic acid, fumarate, others | Change from baseline to 2-hours post L-Phe supplementation |
| Mood | Profile of Mood States (POMS) Outcome | Change from baseline to 2-hours post L-Phe supplementation |
| Blood Pressure | Systolic and Diastolic | Change from baseline to 1-hour and 2-hours post L-Phe supplementation |
| Impulsivity | BIS-Brief Outcome | Baseline |
| Trial-by-trial analysis | To be conducted if there are significant findings from the four main stop signal task outcomes | Change from baseline to 2-hours post L-Phe supplementation |
| D000601 | Amino Acids, Essential |