L-Phenylalanine for Phenylketonuria Carriers (Phe for Me Trial)

N/A

Recruiting

Research Sponsored by University of Guelph

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Carrier or non-carrier of PKU

At least 18 Years of age

Must not have

Diagnosed with hypertension

Diagnosed with severe neurodegenerative conditions affecting cognition (e.g. Alzheimer's, Parkinson's, dementia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 2-hours post l-phe supplementation

Awards & highlights

No Placebo-Only Group

Summary

This trial studies changes in mental health & cognitive performance in people with & without PKU after taking a phenylalanine supplement.

Who is the study for?

This trial is for adults who either carry the PKU gene or do not, and are comfortable fasting in the morning. It's not for those with melanoma, hypertension, liver or kidney disease, pregnant/breastfeeding women, individuals over 150 kg, parents of children with PKU, people with severe cognitive conditions like Alzheimer's or on certain antidepressants.

What is being tested?

The study tests how a supplement called L-Phenylalanine (L-Phe) affects mental health and cognition in both carriers and non-carriers of PKU. Participants will take L-Phe mixed with water and orange juice after fasting and undergo various health assessments before and after consumption.

What are the potential side effects?

Participants may experience side effects from consuming L-Phe which they'll report during the study. Specific side effects aren't listed but could include changes in mood or cognition based on the assessments being conducted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I either have or do not have PKU.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with high blood pressure.

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I have been diagnosed with a severe condition like Alzheimer's affecting my thinking.

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I have been diagnosed with kidney disease.

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My body weight is 150 kg or more.

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I have been diagnosed with PKU.

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I have been diagnosed with melanoma.

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I am taking a monoamine oxidase inhibitor for depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 1-hour and 2-hours post l-phe supplementation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 1-hour and 2-hours post l-phe supplementation

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1-hour and 2-hours post l-phe supplementation for reporting.