Recruiting

Leucine Requirement

Sponsor:

University of British Columbia

Code:

NCT07492095

Conditions

Nutrient Intake

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Accepted

Interventions

Leucine Intake

Study Details

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

Study ID

NCT07492095

Start date

Jun 25, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

7 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Test Leucine Intakes

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.

Interventions

Leucine Intake

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.

Primary outcome measure

  • Carbon-13 Oxidation [ Time Frame: 8 hours (1 study day) ]

Central Contacts and Locations

Central contacts

Kendall Plant

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

Rajavel Elango

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

Locations

BC Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

Principal Investigator:

Rajavel Elango

More Information

Sponsor

University of British Columbia

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Leucine
  • School-Age Children
  • Amino Acid
  • Isotope

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-07-08.