NCT02819505

Brief Summary

Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the extension of physical exercise, counteracting the decline in muscle performance due to fatigue. However this process is largely restricted by the levels of β-alanine available in the human body. Carnosine levels can be raised through long term ingestion of food products, such as meat, fish and poultry, however it can also be significantly increased by β-alanine supplementation. Improved β-alanine levels can potentially advance exercise capacity and exercise performance, which may have been previously limited. Recently research has demonstrated no beneficial effect of β-alanine supplementation on neuromuscular performance in active, healthy males when they were well rested, with no prior exercise or fatigue of the assessed muscle. It remains unknown if β-alanine supplementation would aid physical performance when the muscle has already been fatigued. This is currently being investigated in older adults (60-80 years), however there is no clear comparison between the potential effects in younger and older participants. Therefore this investigation hopes to examine the effects of 4 week β-alanine supplementation on lower limb contractile and force properties, pre and post muscle specific fatigue in 18-30 year old males.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4

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

December 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

June 21, 2016

Last Update Submit

June 27, 2016

Conditions

Keywords

beta-alaninecarnosineneuromuscularstimulationskeletal muscle

Outcome Measures

Primary Outcomes (1)

  • Half relaxation time

    The time taken to decline to 50% maximum following a evoked twitch contraction

    4 weeks

Secondary Outcomes (5)

  • Force frequency relationship

    4 weeks

  • Time to peak tension

    4 weeks

  • Electromechanical delay

    4 weeks

  • Maximal voluntary force production

    4 weeks

  • Explosive voluntary force production

    4 weeks

Study Arms (2)

Beta-alanine supplementation

EXPERIMENTAL

Participants will be supplemented with 6.4g·d-1 β-alanine (CarnoSyn™, NAI, USA). The β-alanine dosing regimen will consist of two 800 mg tablets four times per day at 3-4 hour intervals or the same regimen for placebo tablets. The use of multiple small doses throughout the day has been used in numerous studies using β-alanine in solutions or gelatine capsules (Hoffman et al., 2008; Sale et al., 2011; Saunders et al., 2012; Sale et al., 2012; Tobias et al., 2013) in order to circumvent potential symptoms of paraesthesia (see box xii for possible risks and discomforts). Overall increases have been shown to be between 40% and 80% depending upon dose (between 3.2 and 6.4 g·d-1) and duration of administration (between 4 and 10 weeks) (Sale et al., 2012).

Dietary Supplement: beta-alanine

Placebo supplementation

PLACEBO COMPARATOR

Participants will be supplemented with 6.4g·d-1 placebo (maltodextrin; NAI, USA).

Dietary Supplement: Placebo

Interventions

beta-alanineDIETARY_SUPPLEMENT
Beta-alanine supplementation
PlaceboDIETARY_SUPPLEMENT
Placebo supplementation

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • physically active
  • male

You may not qualify if:

  • vegetarian/vegan
  • have been using β-alanine or carnosine supplements within the past 6 months
  • Bone disorders in the assessed lower limb, sustained within the previous 2 years, including osteoarthritis, osteoporosis, bone cyst and osteopenia.
  • Non-arthroscopic joint surgery, or joint replacement, ever, in the assessed limb (knee, hip and ankle).
  • Lower limb leg injuries including sprains and strains, joint dislocations and fractures.
  • Regular knee pain in the assessed limb when performing daily movement tasks.
  • Participation within a resistance training programme in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Sale C, Saunders B, Harris RC. Effect of beta-alanine supplementation on muscle carnosine concentrations and exercise performance. Amino Acids. 2010 Jul;39(2):321-33. doi: 10.1007/s00726-009-0443-4. Epub 2009 Dec 20.

    PMID: 20091069BACKGROUND
  • Sale C, Artioli GG, Gualano B, Saunders B, Hobson RM, Harris RC. Carnosine: from exercise performance to health. Amino Acids. 2013 Jun;44(6):1477-91. doi: 10.1007/s00726-013-1476-2. Epub 2013 Mar 12.

    PMID: 23479117BACKGROUND
  • Harris RC, Sale C. Beta-alanine supplementation in high-intensity exercise. Med Sport Sci. 2012;59:1-17. doi: 10.1159/000342372. Epub 2012 Oct 15.

    PMID: 23075550BACKGROUND
  • Artioli GG, Gualano B, Smith A, Stout J, Lancha AH Jr. Role of beta-alanine supplementation on muscle carnosine and exercise performance. Med Sci Sports Exerc. 2010 Jun;42(6):1162-73. doi: 10.1249/MSS.0b013e3181c74e38.

    PMID: 20479615BACKGROUND
  • Jones RL, Barnett CT, Davidson J, Maritza B, Fraser WD, Harris R, Sale C. beta-alanine supplementation improves in-vivo fresh and fatigued skeletal muscle relaxation speed. Eur J Appl Physiol. 2017 May;117(5):867-879. doi: 10.1007/s00421-017-3569-1. Epub 2017 Mar 27.

MeSH Terms

Interventions

beta-Alanine

Intervention Hierarchy (Ancestors)

AlanineAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Associate

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 30, 2016

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share