NCT03655041

Brief Summary

Although β-alanine (BA) has been shown to be an effective ergogenic aid, little information exists on the safety of chronic supplementation despite potential concerns. The aim of this study was to investigate the effects of chronic BA supplementation on muscle taurine content, blood clinical markers and sensory side-effects during 24 weeks of BA supplementation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

August 28, 2018

Last Update Submit

August 29, 2018

Conditions

Sports Nutritional Physiological Phenomena

Keywords

Physiological Phenomena

Outcome Measures

Primary Outcomes (1)

  • Muscle taurine content in mmol/kg

    Change in the content of taurine in muscle will be determined using High-Pressure Liquid Chromatography of muscle biopsies

    Up to 24 weeks

Secondary Outcomes (2)

  • Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase in U/L

    Up to 24 weeks

  • Albumin; globulin; creatinine in mg/dL

    Up to 24 weeks

Study Arms (2)

Beta-Alanine

EXPERIMENTAL

6.4 g/day of beta-alanine for 24 weeks

Dietary Supplement: Beta-alanine

Placebo

PLACEBO COMPARATOR

6.4 g/day of maltodextrin for 24 weeks

Dietary Supplement: Placebo

Interventions

Beta-alanineDIETARY_SUPPLEMENT

Beta-alanine in sustained-release tablets to increase muscle carnosine content

Beta-Alanine
PlaceboDIETARY_SUPPLEMENT

Maltodextrin is used as a placebo as it does not lead to any increases in muscle carnosine

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy males

You may not qualify if:

  • Smokers
  • Chronic disease
  • Prior or current use of steroids
  • Use of creatine in the last 6 months
  • Use of beta-alanine in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

beta-Alanine

Intervention Hierarchy (Ancestors)

AlanineAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Bruno Gualano, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

February 1, 2013

Primary Completion

December 15, 2015

Study Completion

December 15, 2017

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share