Leucine Intake for Nutritional Needs in Children

Overseen By Rajavel Elango

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Prescription medications

Disqualifiers: Acute or chronic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on determining the necessary amount of leucine, an essential amino acid crucial for muscle growth, in the diets of children aged 6 to 10. Since the body cannot produce leucine, it must be obtained from food sources such as meat, eggs, and beans. Currently, children's leucine needs rely on adult guidelines, and the study aims to establish accurate recommendations for kids. The trial includes children who are generally healthy and within a specific weight range. Researchers will provide participants with varying levels of dietary leucine to identify the optimal intake for healthy growth. As an unphased study, this research offers participants a unique opportunity to contribute to essential nutritional guidelines for children.

What prior data suggests that this technique is safe for children?

Research has shown that leucine is generally safe when consumed in the right amounts. Studies suggest that young men can safely consume up to 500 mg of leucine per kilogram of body weight each day, which exceeds typical dietary intake. Another study found that adults can safely take up to 0.53 grams per kilogram each day, further confirming leucine's safety.

In children, leucine has been found to aid muscle growth without causing problems when included in protein-rich diets. These findings indicate that leucine is well-tolerated by healthy individuals, including children. Overall, leucine appears to be a safe supplement, especially when taken within recommended limits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Leucine intake is unique because it directly addresses the nutritional needs of children by providing varying levels of an essential amino acid, which is vital for growth and development. Unlike other nutritional treatments that might not target specific amino acids, leucine could offer more tailored nutritional support. Researchers are excited about this treatment because it explores different intake levels, allowing for a personalized approach that could optimize health outcomes in children.

What evidence suggests that leucine intake is effective for children's nutritional needs?

Studies have shown that leucine, an important nutrient, helps muscles grow and heal. Research indicates that leucine intake can boost muscle building, especially in young animals like baby pigs. In children, higher dietary leucine levels have been linked to better muscle health, particularly after exercise. Although most studies focus on specific age groups or conditions, the benefits of leucine for muscle health are well-documented, suggesting it could aid children's growth. Early findings suggest leucine may improve muscle function, which is crucial for growing kids. This trial will test various leucine intake levels to determine the optimal amount for supporting muscle health in children. ^{1 2 4 6 7}

Who Is on the Research Team?

Rajavel Elango

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a healthy child between 6 and 10 years old.

Assent from the child and written informed consent from parent(s) and/or legal guardian(s)

Body weight between the 3rd and 85th percentile according to WHO Child Growth Standards

Exclusion Criteria

I have been diagnosed with a medical condition, either short-term or long-term.

I am currently taking medication that affects my protein or energy metabolism.

I have lost weight recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-study Visit

Participants complete a pre-study visit to prepare for the IAAO study visits

1 day

1 visit (in-person)

IAAO Study Visits

Participants undergo 5 study visits with randomized leucine intake levels and breath sample collection

5 days

5 visits (in-person)

Follow-up

Participants are monitored for any adverse effects and overall health post-study

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Leucine

How Is the Trial Designed?

Group I: Test Leucine Intakes Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4304911/

Leucine is a major regulator of muscle protein synthesis in ...

Supplementation with leucine, provided either parenterally or enterally, has been shown to enhance muscle protein synthesis in neonatal pigs.

2.

jsmcentral.org

jsmcentral.org/assets/articles/smjfnd-v4-1023.pdf

Effectiveness of Leucine Supplementation in the ...

If a child responds positively to this treatment they progress to moderate wasting but there is no standardized treatment protocol despite ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01172301

Leucine-enriched Essential Amino Acid Intake to Optimize ...

In this study, we will test the following hypothesis: A high-leucine essential amino acid mixture (dose of 6.7 g) will stimulate protein anabolism to a greater ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4713246/

Leucine supplementation of a chronically restricted protein ...

Leucine supplementation increases muscle mTOR activation, but does not improve body weight gain or enhance skeletal muscle protein synthesis in neonatal pigs.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S002231662210725X

Postexercise Dietary Protein Ingestion Increases Whole ...

This study determined the effect of increasing doses of ingested protein on postexercise whole-body leucine balance in healthy, active children.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27138628/

Determination of the safety of leucine supplementation in ...

The tolerable upper intake level (UL) for leucine intake in young men has recently been determined to be 500 mg kg(-1) day(-1), and increases in blood ammonia ...

7.

jn.nutrition.org

jn.nutrition.org/article/S0022-3166(22)02609-8/fulltext

A Proposal for an Upper Limit of Leucine Safe Intake in ...

Based on recent research, an upper limit of safe intake (ULSI) for leucine is proposed for healthy adults: 0.53 g/(kg·d). Because leucine has been used as a ...