Children Clinical Trial
Official title:
Determining the Optimal Ratio of Branched Chain Amino Acids in Medical Foods for Methylmalonic and Propionic Acidemias (MMA/PROP)
NCT number | NCT03539809 |
Other study ID # | H18-00439 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | May 31, 2019 |
This study will evaluate the branched-chain amino acids (BCAA) ratio in the medical foods formulated for Methylmalonic and Propionic Acidemias (MMA/PROP) patients. We will recruit 6 healthy children between 6-10y (3 boys and 3 girls). They will be given amino acid-based shakes and protein free cookies. Using a minimally invasive stable isotope based technique, we will be able to determine the optimal ratio of BCAA to be added in the medical foods for the MMA/PROP subjects.
Status | Recruiting |
Enrollment | 6 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 10 Years |
Eligibility |
Inclusion Criteria: - Healthy school-aged children 6-10y - Normal weight - Normal eating habits - English speaking children Exclusion Criteria: - Children under 6 years old, or over 10 years old. - Children who are currently ill, with a fever, cold, vomiting or diarrhea. - Children outside of normal weight parameters (3rd -85th percentiles for weight). - Children with claustrophobia. - Children currently or recently taking medication or antibiotics. - Children with food allergies. - Children who cannot speak, write and read in English |
Country | Name | City | State |
---|---|---|---|
Canada | BC Children's Hospital Research Institute, University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 13C Phenylalanine Oxidation | Breath and Urine samples will be collected during the study to measure 13C Phenylalanine oxidation | 8 hours | |
Secondary | Urinary Branched Chain amino acids excretion | Urine samples will be collected during the study to measure BCAA urinary excretion | 8 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
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