An interventional study of Free amino acids intake in Phenylketonuria, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by University of British Columbia · Not applicable, Interventional, and Supportive care
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.
183 studies on the registry are indexed under Phenylketonurias; 38 are open to participants now.
This study's enrollment of 6 is below the median of 25 across 114 interventional studies indexed under Phenylketonurias.
Browse Phenylketonurias studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
-Adults more than 19 years of age who are diagnosed with PKU and clinically stable with no acute illness
Exclusion Criteria:
Free amino acids vs. Glycomacropeptide (GMP)
Dietary Supplement: Free amino acids intake
Oral consumption of eight hourly experimental meals- -4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil -4 isotopically labeled experimental meals. The same protocol will be repeated with glycomacropeptide (GMP).
Also known as: glycomacropeptide (GMP) intake
13 Co2 production
Breath samples will be collected during the study to measure the rate of oxidation of tracer in the expired breath.
Time frame: 8 hours (1 study day). 3 samples will collected as a baseline prior to isotope protocol and 6 samples after 2 hours and 30 minutes of starting the tracer protocol. Data will be reported an average of 2 years.
Lysine flux
Urine samples will be collected during the study to measure the flux enrichment in urine.
Time frame: 8 hours (1 study day). 1 sample will collected as a baseline prior to isotope protocol and 2 samples after 2 hours and 30 minutes of starting the tracer protocol. Data will be reported an average of 2 years.
Phenylalanine concentrations
Phenylalanine concentrations will be measured in blood.
Time frame: One sample (at 6th meal) after starting of the tracer protocol. Data will be reported an average of 2 years.
Tyrosine concentrations
Tyrosine concentrations will be measured in blood.
Time frame: One sample (at 6th meal) after starting of the tracer protocol. Data will be reported an average of 2 years.
16 other amino acids
16 other amino acids will be measured in blood.
Time frame: One sample (at 6th meal) after starting of the tracer protocol. Data will be reported an average of 2 years.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University of British Columbia