PKU Carriers Trial (Pilot Study): Impact on Cognition, Mental Health, Blood Pressure and Metabolism

Last updated: December 3, 2024
Sponsor: University of Guelph
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

L-Phenylalanine

Clinical Study ID

NCT05958784
REB23-03-017
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Known carrier or non-carrier of PKU

  • At least 18 years of age

  • Comfortable fasting the morning of the study (no food or drink other than water)

Exclusion

Exclusion Criteria:

  • Diagnosed with: PKU, severe neurodegenerative conditions affecting cognition (e.g.Alzheimer's, Parkinson's, dementia), melanoma, hypertension, liver disease and/orkidney disease

  • Taking a Monoamine Oxidase Inhibitor anti-depressant

  • Pregnant or breastfeeding

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: L-Phenylalanine
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
December 01, 2023

Connect with a study center

  • University of Guelph

    Guelph, Ontario N1G 2W1
    Canada

    Site Not Available

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