Leucine Requirements in School-Age Children

NCT07492095 | Not Yet Recruiting

• 1 other identifier: H26-00055
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nutrient Intake

Keywords

Leucine; School-Age Children; Amino Acid; Isotope

Outcome Measures

Primary Outcomes (1)

• 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.

  8 hours (1 study day)

Secondary Outcomes (1)

• Urinary L-[1-13C] Phenylalanine Flux

  8 hours (1 study day)

Study Arms (1)

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.

Dietary Supplement: Leucine Intake

Interventions

Leucine Intake DIETARY_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.

Test Leucine Intakes

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Study Officials

• Rajavel Elango

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kendall Plant

CONTACT

604-875-2000; kendall.plant@bcchr.ca

Rajavel Elango

CONTACT

604-875-2000; relango@bcchr.ubc.ca

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: March 19, 2026
• First Posted: March 25, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)