NCT02744443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

April 12, 2016

Last Update Submit

April 15, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • muscle cross-sectional area

    B-mode ultrasound

    12 weeks

Secondary Outcomes (1)

  • muscle strength

    12 weeks

Study Arms (2)

Leucine

EXPERIMENTAL

Leucine supplementation (10 g/d)

Dietary Supplement: Leucine

Placebo

PLACEBO COMPARATOR

Placebo supplementation (alanine, 10 g/d)

Dietary Supplement: Placebo

Interventions

LeucineDIETARY_SUPPLEMENT
Leucine
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-30, Brazil

Location

MeSH Terms

Interventions

Leucine

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 20, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 20, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)