Leucine Supplementation in Young Subjects Undergoing Resi... | NCT02744443

Studies
Leucine Supplementation in Young Subjects Undergoing Resistance Training

NCT02744443

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Apr 20, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Leucine
Placebo

Countries

Brazil

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

Apr 2016

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

Jan 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Apr 12, 2016

First Submission Date that Met QC Criteria

Apr 15, 2016

First Posted Date

Apr 20, 2016Estimated

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

Apr 15, 2016

Last Update Posted Date

Apr 20, 2016Estimated

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

Leucine supplementation could be useful to support muscle anabolism. This study aims to investigate the effects of leucine supplementation on muscle mass and muscle strength in young subjects undergoing resistance training.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Leucine	Experimental	Leucine supplementation (10 g/d)	Dietary Supplement: Leucine
Placebo	Placebo Comparator	Placebo supplementation (alanine, 10 g/d)	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leucine	Dietary Supplement		Leucine
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
muscle cross-sectional area	B-mode ultrasound	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
muscle strength	One repetition maximum (1RM) on 45º leg press machine and Muscular Endurance Test on 45º leg press machine	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

training experience > 12 months
no previous use of anabolic steroids
no diagnosed diseases or injuries at the time of recruitment
one-maximum repetition strength (1-RM) in leg press ≥ 3.5 and ≤ 5.0 times the body weight

Exclusion Criteria:

use of creatine or beta-alanine supplements for the last 3 months
use of protein or aminoacids supplements for the last 1 month
engagement in specific dietary restrictions
engagement in competitive sports

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Sao Paulo		São Paulo	São Paulo	05508-30	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007930	Leucine

Ancestor Terms

ID	Term
D000597	Amino Acids, Branched-Chain
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000601	Amino Acids, Essential

Browse Leaves

Not provided

Browse Branches

Not provided