Upper Limit of Leucine Intake in Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Leucine Increase

• Registration Number: NCT00972582
• Lead Sponsor: The Hospital for Sick Children

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

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-09-04
• Study First Posted: 2009-09-07
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-26
• Last Update Posted: 2013-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leucine	Leucine Increase	-

Primary Outcome Measures

Name	Time	Method
Breath carbon dioxide production	Study Visits 1-7 (-45min,-30min,-15min, +2.5hrs, +3hrs, +3.5Hrs +4hrs)

Secondary Outcome Measures

Name	Time	Method
Urine	Study Visits 1-7 (8hr timepoint)
VCO2	Study Visits 1-7 (after 5hr meal)
Plasma	Study Visits 1-7 (Hourly)

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada