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Upper Limit of Leucine Intake in Adults

Determination of the Tolerable Upper Limit of Leucine Intake in Adult Humans

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00972582
Enrollment
5
Registered
2009-09-07
Start date
2009-05-31
Completion date
2010-02-28
Last updated
2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

leucine intake, tolerable upper limit, adults, amino acid supplements, Excessive Leucine Intake

Brief summary

When dietary amino acid supplements are consumed by humans they are normally in addition to their normal daily requirements. The investigators' laboratory played a leading role in defining the estimated average requirement (EAR) and the recommended dietary intake for the essential amino acids (Dietary Reference Intakes 2005). The other important but less well studied component of Dietary Reference Intakes (DRI) is - What is a safe upper limit of intake? The investigators now propose to determine the safe upper limits of the dietary essential amino acids. The recently published DRI (2005) defines the Tolerable Upper Intake Level (UL) as 'the highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population.' As intake increases above the UL, the potential risk of adverse effects may increase'. In this proposal, the investigators define a novel method to define the safe upper limit where the 'maximum oxidative potential' of an amino acid identifies the 'metabolic limit' to dispose the amino acid. Intakes of amino acid above this level will increase the potential for adverse effects to appear.

Detailed description

The objective of the study will be to determine the 'metabolic limit' of leucine oxidation in healthy young men by: A) Measuring leucine oxidation in response to short term (8 hr) graded excess leucine intake B) Correlating changes in leucine oxidation with changes in plasma concentrations of keto-isocaproic acid (KIC, the first breakdown product of leucine metabolism), other essential amino acids, ammonia, urea, creatinine, glucose, insulin, and electrolytes (sodium, potassium, chloride) to identify potential biomarkers C) Correlating changes in leucine oxidation with changes in urinary excretion of leucine and ketoisocaproic acid (KIC), urea and creatinine to identify potential biomarkers

Interventions

DIETARY_SUPPLEMENTLeucine Increase

Graded stepwise increases in leucine intakes (50, 250, 500, 750, 1000, 1250 and 1500mg/kg/day)

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Male * 18-35 years old

Exclusion criteria

* Report a recent history of sudden weight loss * Have unusual dietary habits such as chronic consumption of caffeinated beverages or alcohol * Have any endocrine disorders * Are currently using any prescribed medications

Design outcomes

Primary

MeasureTime frame
Breath carbon dioxide productionStudy Visits 1-7 (-45min,-30min,-15min, +2.5hrs, +3hrs, +3.5Hrs +4hrs)

Secondary

MeasureTime frame
PlasmaStudy Visits 1-7 (Hourly)
UrineStudy Visits 1-7 (8hr timepoint)
VCO2Study Visits 1-7 (after 5hr meal)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026