Nutrient IntakeNCT07492095
Leucine Requirements in School-Age Children
A study testing Leucine Intake in people with Nutrient Intake, run by University of British Columbia at 1 site in Canada.
Trial summary
Leucine is an essential amino acid, which serves a special purpose of signaling cell growth in muscle in addition to making up protein. Essential amino acids like leucine need to be eaten every day from our foods like meat, dairy, eggs, beans, and nuts, as they cannot be made by our bodies. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrient Intake
- What is being tested?
- Leucine Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children
- Aged 6 to 10 years at enrollment
- Body weight between the 3rd and 85th percentile according to WHO Child Growth Standards
- Assent from the child and written informed consent from parent(s) and/or legal guardian(s)
Who cannot join
- Diagnosis of any acute or chronic medical condition
- Current use of prescription medication that may affect protein or energy metabolism
- Recent weight loss
- Recent illness (fever, vomiting, severe runny nose within the past 5 days)
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z 4H4
Rajavel Elango
About this study
Official title: Determination of Leucine Requirements in Healthy School-Age Children Using the Indicator Amino Acid Oxidation Method
Leucine is an essential amino acid, which serves a special purpose of signaling cell growth in muscle in addition to making up protein. Essential amino acids like leucine need to be eaten every day from our foods like meat, dairy, eggs, beans, and nuts, as they cannot be made by our bodies. The current recommendation for leucine in the diet of school-age children are based upon adult needs. This study will measure the leucine requirement in children aged 6-10 years old using an non-invasive technique with special diets, safe stable isotopes, and simple breath collections. Creating guidelines based on measured requirements for leucine in this age group is essential for supporting optimal growth in healthy children.
Read the detailed description
Purpose:
- The purpose of this study is to determine the requirement of the essential amino acid leucine, in school-aged children (6-10 years old), with the minimally invasive indicator amino acid oxidation (IAAO) protocol.
Hypothesis:
- The leucine requirement for healthy school-age children is higher than current 2005 recommendation of 40-49 mg/kg/d when measured using the IAAO method.
Justification:
- Protein is essential for growth, tissue repair, and maintenance of physiological functions throughout the lifecycle. Dietary protein is particularly important during childhood to support a healthy growth trajectory and lean body mass development. Despite the importance of protein to support early life growth and development, childhood protein requirements are largely extrapolated from adult values, and not on pediatric-specific data. Consequently, the current leucine recommendations for children of 40-49 mg/kg/d may not accurately reflect the physiological needs of growth.
Objectives:
- Primary Objective: To determine the leucine requirement in healthy school-aged children using IAAO.
- Secondary Objective: To quantify urinary flux of L-[1-13C] phenylalanine as an additional measure of amino acid metabolism during the experimental protocol.
Research Design:
- Randomized crossover metabolic design based on the IAAO technique to estimate the minimum dietary requirement for leucine. The repeated measures study design involves 7 children (participants) completing 1 pre-study visit and 5 IAAO study visits each with a randomized leucine intake.
- After a 10h fast, each child (participant) is randomized to receive 1 of 7 leucine intake levels (10, 20, 30, 40, 50, 60 or 80 mg/kg/d). On the study day, the diet is administered hourly as eight isonitrogenous, isocaloric meals. Each meal consists of two protein-free cookies and a formulated drink prepared with crystalline amino acids, a flavoured protein-free liquid (powdered drink mix), and corn oil. Multivitamin supplements are provided throughout the study to ensure adequate micronutrient intake. The study diet provides an energy intake equivalent to 1.7 x resting energy expenditure and 1.5 g/kg protein.
- The principle underlying IAAO is that when the intake of an essential amino acid is insufficient, protein synthesis cannot proceed, and the remaining amino acids, unable to be stored, are oxidized. This physiological process can be leveraged by administering a stable isotope-labeled "indicator" amino acid, L-[1-13C]-phenylalanine. When requirements are met, the indicator is incorporated into body protein, but when an amino acid is limiting, the indicator is oxidized, and its labeled carbon appears as 13CO2 in the breath.
- Conditions
- Nutrient Intake
- Being tested
- Leucine Intake
- Keywords
- Leucine, School-Age Children, Amino Acid, Isotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucine IntakeDietary supplement
Participants consume 8 hourly meals that contain the assigned test leucine intake. Each meal will provide one-twelfth of the participants' daily energy requirements as estimated by 1.7 x Resting Energy Expenditure (REE) and adequate protein at 1.5 g/kg/d, to maintain a metabolic steady state. The meals are in the form of a crystalline amino acid protein shake, and protein-free cookies.
| Study group | Role | What they receive |
|---|---|---|
| Test Leucine Intakes | Experimental | Randomized to receive 1 of 7 leucine intake levels (10, 20, 30, 40, 50, 60 or 80 mg/kg/d). Participants will complete up to 5 test intake allocations. Receives: Dietary Supplement: Leucine Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon-13 Oxidation
9 breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath.
Measured: 8 hours (1 study day)
Secondary outcomes (1)
Urinary L-[1-13C] Phenylalanine Flux
3 urine samples will be collected during the study day to measure urinary excretion of phenylalanine
Measured: 8 hours (1 study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start25 Jun 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient IntakeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492095
- Sponsor's protocol ID
- H26-00055
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Leucine Requirements in Healthy School-Age Children Using the Indicator Amino Acid Oxidation Method
- ClinicalTrials.gov ID
- NCT07492095
- Acronym / sponsor ID
- H26-00055
- Conditions
- Nutrient Intake
- Keywords
- Leucine, School-Age Children, Amino Acid, Isotope
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leucine is an essential amino acid, which serves a special purpose of signaling cell growth in muscle in addition to making up protein. Essential amino acids like leucine need to be eaten every day from our foods like meat, dairy, eggs, beans, and nuts, as they cannot be made by our bodies. The current recommendation for leucine in the diet of school-age children are based upon adult needs. This study will measure the leucine requirement in children aged 6-10 years old using an non-invasive technique with special diets, safe stable isotopes, and simple breath collections. Creating guidelines based on measured requirements for leucine in this age group is essential for supporting optimal growth in healthy children.
Detailed description
Purpose:
- The purpose of this study is to determine the requirement of the essential amino acid leucine, in school-aged children (6-10 years old), with the minimally invasive indicator amino acid oxidation (IAAO) protocol.
Hypothesis:
- The leucine requirement for healthy school-age children is higher than current 2005 recommendation of 40-49 mg/kg/d when measured using the IAAO method.
Justification:
- Protein is essential for growth, tissue repair, and maintenance of physiological functions throughout the lifecycle. Dietary protein is particularly important during childhood to support a healthy growth trajectory and lean body mass development. Despite the importance of protein to support early life growth and development, childhood protein requirements are largely extrapolated from adult values, and not on pediatric-specific data. Consequently, the current leucine recommendations for children of 40-49 mg/kg/d may not accurately reflect the physiological needs of growth.
Objectives:
- Primary Objective: To determine the leucine requirement in healthy school-aged children using IAAO.
- Secondary Objective: To quantify urinary flux of L-[1-13C] phenylalanine as an additional measure of amino acid metabolism during the experimental protocol.
Research Design:
- Randomized crossover metabolic design based on the IAAO technique to estimate the minimum dietary requirement for leucine. The repeated measures study design involves 7 children (participants) completing 1 pre-study visit and 5 IAAO study visits each with a randomized leucine intake.
- After a 10h fast, each child (participant) is randomized to receive 1 of 7 leucine intake levels (10, 20, 30, 40, 50, 60 or 80 mg/kg/d). On the study day, the diet is administered hourly as eight isonitrogenous, isocaloric meals. Each meal consists of two protein-free cookies and a formulated drink prepared with crystalline amino acids, a flavoured protein-free liquid (powdered drink mix), and corn oil. Multivitamin supplements are provided throughout the study to ensure adequate micronutrient intake. The study diet provides an energy intake equivalent to 1.7 x resting energy expenditure and 1.5 g/kg protein.
- The principle underlying IAAO is that when the intake of an essential amino acid is insufficient, protein synthesis cannot proceed, and the remaining amino acids, unable to be stored, are oxidized. This physiological process can be leveraged by administering a stable isotope-labeled "indicator" amino acid, L-[1-13C]-phenylalanine. When requirements are met, the indicator is incorporated into body protein, but when an amino acid is limiting, the indicator is oxidized, and its labeled carbon appears as 13CO2 in the breath.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Leucine Intakes | Experimental | Dietary Supplement: Leucine IntakeRandomized to receive 1 of 7 leucine intake levels (10, 20, 30, 40, 50, 60 or 80 mg/kg/d). Participants will complete up to 5 test intake allocations. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children
- Aged 6 to 10 years at enrollment
- Body weight between the 3rd and 85th percentile according to WHO Child Growth Standards
- Assent from the child and written informed consent from parent(s) and/or legal guardian(s)
Key exclusion criteria (5 listed)
- Diagnosis of any acute or chronic medical condition
- Current use of prescription medication that may affect protein or energy metabolism
- Recent weight loss
- Recent illness (fever, vomiting, severe runny nose within the past 5 days)
- Inability to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leucine IntakeParticipants consume 8 hourly meals that contain the assigned test leucine intake. Each meal will provide one-twelfth of the participants' daily energy requirements as estimated by 1.7 x Resting Energy Expenditure (REE) and adequate protein at 1.5 g/kg/d, to maintain a metabolic steady state. The meals are in the form of a crystalline amino acid protein shake, and protein-free cookies. | Dietary supplement | Test Leucine Intakes |
Primary outcome
Carbon-13 Oxidation
Time frame: 8 hours (1 study day)
9 breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath.
1 secondary outcome
Urinary L-[1-13C] Phenylalanine Flux
Time frame: 8 hours (1 study day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to share data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajavel Elango principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine Intake in people with Nutrient Intake, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kendall Plant (604-875-2000 ext. 4607, kendall.plant@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbon-13 Oxidation (time frame: 8 hours (1 study day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.