Upper Limit of Leucine Intake in Adults | NCT00972582

Studies
Upper Limit of Leucine Intake in Adults

NCT00972582

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Jul 29, 2013Estimated

Enrollment

5Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Leucine Increase

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Sep 4, 2009

First Submission Date that Met QC Criteria

Sep 4, 2009

First Posted Date

Sep 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2013

Last Update Posted Date

Jul 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Paul Pencharz, Emeritus Scientist, The Hospital for Sick ChildrenPrincipal Investigator

Lead Sponsor

The Hospital for Sick ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Leucine	Experimental		Dietary Supplement: Leucine Increase

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leucine Increase	Dietary Supplement	Graded stepwise increases in leucine intakes (50, 250, 500, 750, 1000, 1250 and 1500mg/kg/day)	Leucine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Plasma		Study Visits 1-7 (Hourly)
Urine		Study Visits 1-7 (8hr timepoint)
VCO2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul B Pencharz, MD	The Hospital for Sick Children, Toronto, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario		Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22952178	Derived	Elango R, Chapman K, Rafii M, Ball RO, Pencharz PB. Determination of the tolerable upper intake level of leucine in acute dietary studies in young men. Am J Clin Nutr. 2012 Oct;96(4):759-67. doi: 10.3945/ajcn.111.024471. Epub 2012 Sep 5.