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Amino Acid Formula

Protein intake for Phenylketonuria

N/A
Waitlist Available
Led By Rajavel Elango, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
-Adults more than 19 years of age who are diagnosed with PKU and clinically stable with no acute illness
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one sample (at 6th meal) after starting of the tracer protocol. data will be reported an average of 2 years.
Awards & highlights

Study Summary

Phenylketonuria (PKU) is an inherited inborn error of phenylalanine (PHE) metabolism caused by decreased activity of phenylalanine hydroxylase (PAH) enzyme. Therefore, PHE accumulates in plasma leading to mental problems. Treatment is a phenylalanine-restricted diet with sufficient protein. However, the optimum protein requirements are still unknown and compliance with diet is not satisfactory in PKU adults. A Previously established technique called indicator amino acid oxidation (IAAO) will be used to determine protein requirements from amino acid based formula vs. glycomacropeptide (GMP) in adults with PKU (≥ 19y). This study will help treat adults with enough protein ensuring maintenance of health.

Eligible Conditions
  • Phenylketonuria

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one sample (at 6th meal) after starting of the tracer protocol. data will be reported an average of 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and one sample (at 6th meal) after starting of the tracer protocol. data will be reported an average of 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
13 Co2 production
Lysine flux
Secondary outcome measures
16 other amino acids
Phenylalanine concentrations
Tyrosine concentrations

Trial Design

1Treatment groups
Experimental Treatment
Group I: Protein intakeExperimental Treatment1 Intervention
Free amino acids vs. Glycomacropeptide (GMP)

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,467,112 Total Patients Enrolled
Vitaflo International, LtdIndustry Sponsor
27 Previous Clinical Trials
530 Total Patients Enrolled
Sandra Sirrs, MDStudy ChairUniversity of British Columbia
1 Previous Clinical Trials
320 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Protein Requirements in Adults With Phenylketonuria (PKU)
Rajavel Elango, PhD 2019. "Protein Requirements in Adults With Phenylketonuria (PKU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03939052.
All > Phenylketonuria
~1 spots leftby May 2025
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