Leucine Requirements in School-Age Children (NCT07492095) | Clinical Trial Compass
RecruitingNot Applicable
Leucine Requirements in School-Age Children
Canada7 participantsStarted 2026-06-25
Plain-language 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.
Who can participate
Age range
6 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for us to check back closer to that date?
2The trial is measuring something called Carbon-13 Oxidation to figure out leucine requirements in school-age children — can you explain in plain terms what that measurement involves and whether it requires any special procedures or dietary restrictions for my child?
3Since this study is focused on nutrient intake and leucine requirements rather than treating a disease, how would participating affect my child's normal diet or nutrition routine during the study period?
4This trial doesn't have a traditional phase assigned to it, which suggests it may be more of a nutritional science study than a drug trial — can you help me understand what that means for my child's safety and what risks, if any, might be involved?
5Are there standard nutritional assessments or dietary guidance we should be pursuing right now through your care, rather than waiting for this trial to begin recruiting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.