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Branched Chain Amino Acids Ratio in Medical Foods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03539809
Recruitment Status : Unknown
Verified May 2018 by Rajavel Elango, PhD, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Children Dietary Supplement: L-Amino Acids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determining the Optimal Ratio of Branched Chain Amino Acids in Medical Foods for Methylmalonic and Propionic Acidemias (MMA/PROP)
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BCAA Ratio
Different Branched-chain amino acid (BCAA) ratios will be tested. BCAA are comprised of 3 different amino acids (leucine, isoleucine and valine). The ratios among these 3 amino acids will be tested at 6 different ratios. Each intervention will be for 8hours.
Dietary Supplement: L-Amino Acids
6 different ratios of the Branched-chain Amino Acids (BCAA) will be tested for 8 hours each.

Primary Outcome Measures :
  1. 13C Phenylalanine Oxidation [ Time Frame: 8 hours ]
    Breath and Urine samples will be collected during the study to measure 13C Phenylalanine oxidation

Secondary Outcome Measures :
  1. Urinary Branched Chain amino acids excretion [ Time Frame: 8 hours ]
    Urine samples will be collected during the study to measure BCAA urinary excretion

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03539809

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Contact: Rajavel Elango, Ph.D 604 875 2000 ext 4911
Contact: Haneen Saleemani, MSc 604 875 2000 ext 4607

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Canada, British Columbia
BC Children's Hospital Research Institute, University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z4H4
Contact: Rajavel Elango, Ph.D         
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Rajavel Elango, Ph.D University of British Columbia
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Responsible Party: Rajavel Elango, PhD, Principal Investigator, University of British Columbia Identifier: NCT03539809    
Other Study ID Numbers: H18-00439
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajavel Elango, PhD, University of British Columbia:
Branched Chain Amino Acids
Direct Amino Acid Oxidation
Stable isotopes