Branched Chain Amino Acids Ratio in Medical Foods

NCT03539809 | Completed

• 1 other identifier: H18-00439
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Children

Keywords

Branched Chain Amino Acids; Direct Amino Acid Oxidation; Stable isotopes

Outcome Measures

Primary Outcomes (1)

• 13C Phenylalanine Oxidation

  Breath and Urine samples will be collected during the study to measure 13C Phenylalanine oxidation

  8 hours

Secondary Outcomes (1)

• Urinary Branched Chain amino acids excretion

  8 hours

Study Arms (1)

BCAA Ratio

EXPERIMENTAL

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

Interventions

L-Amino Acids DIETARY_SUPPLEMENT

6 different ratios of the Branched-chain Amino Acids (BCAA) will be tested for 8 hours each.

BCAA Ratio

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy school-aged children 6-10y
• Normal weight
• Normal eating habits
• English speaking children

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

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

Vancouver, British Columbia, V5Z4H4, Canada

Location

Study Officials

• Rajavel Elango, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: June 1, 2018
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)