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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Protein Requirements in Adults With Phenylketonuria (PKU)

Clinicaltrials.gov identifier NCT03939052

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted August 22, 2019

Study Description

Brief 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.

  • Condition or Disease:Phenylketonuria
  • Intervention/Treatment: Dietary Supplement: Free amino acids intake
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 6 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Protein Requirements in Phenylketonuria (PKU) Patients Compared Using PKU Sphere™ | Glycomacropeptide (GMP) and an L-amino Acid-based Product
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: May 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Protein intake
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).
Outcome Measures
  • Primary Outcome Measures: 1. 13 Co2 production [ 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. ]
    Breath samples will be collected during the study to measure the rate of oxidation of tracer in the expired breath.
  • 2. Lysine flux [ 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. ]
    Urine samples will be collected during the study to measure the flux enrichment in urine.
  • Secondary Outcome Measures: 1. Phenylalanine concentrations [ Time Frame: One sample (at 6th meal) after starting of the tracer protocol. Data will be reported an average of 2 years. ]
    Phenylalanine concentrations will be measured in blood.
  • 2. Tyrosine concentrations [ Time Frame: One sample (at 6th meal) after starting of the tracer protocol. Data will be reported an average of 2 years. ]
    Tyrosine concentrations will be measured in blood.
  • 3. 16 other amino acids [ 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 will be measured in blood.
Eligibility Criteria
  • Ages Eligible for Study: 19 to 50 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

-Adults more than 19 years of age who are diagnosed with PKU and clinically stable with no
acute illness

Exclusion Criteria:

- Adults with PKU under age 19 year

- Adults diagnosed with PKU but are currently ill with a fever or cold

Contacts and Locations
Contacts

Contact: Rajavel Elango, PhD 604-875-2000 ext 4911 relango@bcchr.ubc.ca

Locations

Canada, British Columbia
BC Children's Hospital Research Institute, University of British Columbia
Vancouver

Sponsors and Collaborators

University of British Columbia

Vitaflo International, Ltd

Investigators

Principal Investigator: Rajavel Elango, PhD BC Children's Hospital Research Institute, University of British Columbia

Study Chair: Sandra Sirrs, MD University of British Columbia

Study Chair: Sylvia Stockler, MD University of British Columbia

More Information
  • Responsible Party: University of British Columbia
  • ClinicalTrials.gov Identifier: NCT03939052 History of Changes
  • Other Study ID Numbers: H18-03464
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: August 22, 2019
  • Last Verified: August 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of British Columbia: Phenylketonuria
    Phenylalanine metabolism
    Protein requirements
    Indicator Amino acid Oxidation
    Stable isotopes
    GMP
    Glycomacropeptide
    PKU
  • Additional relevant MeSH terms: Phenylketonurias