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. |
ClinicalTrials.gov 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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Children | Dietary Supplement: L-Amino Acids | Not Applicable |
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 |
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. |
- 13C Phenylalanine Oxidation [ Time Frame: 8 hours ]Breath and Urine samples will be collected during the study to measure 13C Phenylalanine oxidation
- Urinary Branched Chain amino acids excretion [ Time Frame: 8 hours ]Urine samples will be collected during the study to measure BCAA urinary excretion
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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
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 ClinicalTrials.gov identifier (NCT number): NCT03539809
Contact: Rajavel Elango, Ph.D | 604 875 2000 ext 4911 | relango@bcchr.ubc.ca | |
Contact: Haneen Saleemani, MSc | 604 875 2000 ext 4607 | haneen.saleemani@bcchr.ubc.ca |
Canada, British Columbia | |
BC Children's Hospital Research Institute, University of British Columbia | Recruiting |
Vancouver, British Columbia, Canada, V5Z4H4 | |
Contact: Rajavel Elango, Ph.D |
Principal Investigator: | Rajavel Elango, Ph.D | University of British Columbia |
Responsible Party: | Rajavel Elango, PhD, Principal Investigator, University of British Columbia |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Branched Chain Amino Acids Direct Amino Acid Oxidation Stable isotopes |