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Phe for Me? The Effects of L-Phe on PKU Carriers and Non-carriers

U

University of Guelph

Status

Not yet enrolling

Conditions

Autosomal Recessive Disorder (Genetic Carriers of PKU)

Treatments

Dietary Supplement: L-Phenylalanine

Study type

Interventional

Funder types

Other

Identifiers

NCT06119048
23-03-017

Details and patient eligibility

About

This is a clinical intervention 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-11). 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) as well as for genetic testing of the PAH gene. 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 and heart rate will also be measured at baseline.

Following baseline tests, participants will consume a pure L-Phe supplement dosed at 100 mg/kg mixed with 125 mL of water and 125mL of orange juice. Blood pressure and heart rate 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 and heart rate 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • Have a child with PKU
  • Diagnosed with: PKU, severe neurodegenerative conditions affecting cognition (e.g. Alzheimer's, Parkinson's, dementia), melanoma, hypertension, liver disease and/or kidney disease
  • Diagnosed with hypertension or hypotension
  • Taking a monoamine oxidase inhibitor anti-depressant
  • Pregnant or breastfeeding
  • Orange/citrus allergy or intolerance
  • Body weight 150 kg or greater
  • History of fainting during blood sampling

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Genetic Carriers and Non-Carriers of PKU
Experimental group
Treatment:
Dietary Supplement: L-Phenylalanine

Trial contacts and locations

1

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Central trial contact

Justine R Keathley, PhD

Data sourced from clinicaltrials.gov

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