Muscle FunctionPhase 4NCT02819505
β-alanine Supplementation on Knee Extensor Contractile and Force Properties
A Phase 4 study testing beta-alanine in people with Muscle Function, run by Nottingham Trent University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Function
- What is being tested?
- beta-alanine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- physically active
- male
Who cannot join
- 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
About this study
Official title: The Effects of 4 Week β-alanine Supplementation on Knee Extensor Contractile and Force Properties in Active Male Adults (18-30 Years).
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.
Read the detailed description
Carnosine (β-alanyl-L-histidine) is a naturally occurring dipeptide formed by bonding histidine and β-alanine in a reaction catalysed by carnosine synthase. One role of carnosine within the human system, is as an intracellular pH buffer due to its pKa of 6.83. Carnosine is suitable over the whole exercise induced intramuscular pH transit-range. Carnosine in untrained populations can neutralise 2.4 to 10.1mmol H+.kg-1 of dry mass muscle as intramuscular pH declines, adding at least 7% to 10% to total intramuscular buffering capacity. It has also been argued that carnosine in combination with anserine can contribute as much as 40% to the buffering capacity between pH ranges of 6.5 to 7.5. β-alanine has been suggested as the rate limiting factor for muscle carnosine synthesis, through ingestion of β-alanine in diet (meat, fish and poultry) or via short-term supplementation, demonstrating significant increases in muscle carnosine concentrations. Increases in carnosine concentrations between 40% and 80% have been shown, depending upon dose (between 3.2 and 6.4 g·d-1) and duration of administration (between 4 and 10 weeks). Increasing β-alanine concentrations therefore enhance carnosine synthesis with the muscle fibers and improves intramuscular buffering capacity. Exercise performance and capacity measurements that previously were limited by the accumulation of H+ have been demonstrated significant improvements through supplementation with β-alanine.
Research already conducted at Nottingham Trent University and approved by this ethical advisory committee has demonstrated no significant effect of β-alanine supplementation on neuromuscular performance in healthy, active males. However, this research was conducted with well rested participants, with no prior exercise or fatigue of the assessed muscle; therefore there was no accumulation of H+ demonstrated within the muscle. These previous investigations are therefore contemplating how β-alanine supplementation alters performance when intramuscular buffering has not been altered (at the start of the exercise), whereas the proposed study will examine the effect of β-alanine supplementation on performance when intramuscular pH has already been challenged (due to fatiguing exercise). It is hypothesised that β-alanine supplementation over 4 weeks will beneficially alter the contractile and force properties of the muscle fibres within the lower limb muscles, improving physical performance when the muscle is already fatigued.
Aims of the project:
To examine the effects of 4 week β-alanine supplementation on knee extensor contractile and force properties, pre and post induced muscle specific fatigue in 18-30 year old males.
- Conditions
- Muscle Function
- Being tested
- beta-alanine, Placebo
- Keywords
- beta-alanine, carnosine, neuromuscular, stimulation, skeletal muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-alanineDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: beta-alanine |
| Placebo supplementation | Placebo comparator | Participants will be supplemented with 6.4g·d-1 placebo (maltodextrin; NAI, USA). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Half relaxation time
The time taken to decline to 50% maximum following a evoked twitch contraction
Measured: 4 weeks
Secondary outcomes (5)
Force frequency relationship
Assessed during electrically evoked contractions.
Measured: 4 weeks
Time to peak tension
The time taken to reach peak in evoked twitch contractions
Measured: 4 weeks
Electromechanical delay
The time between EMG onset and force onset in twitch contractions
Measured: 4 weeks
Maximal voluntary force production
The maximal force produced during a voluntary isometric contraction
Measured: 4 weeks
Explosive voluntary force production
The quickest rate of force developed during voluntary isometric contractions at greater than 80% of voluntary maximum, with no pre-tension or swinging back of the assessed leg.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Louise Stannard, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819505
- Sponsor's protocol ID
- 369
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20091069Sale 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.
PubMed 23479117Harris 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.
PubMed 23075550Artioli 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.
PubMed 20479615Jones 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.
PubMed 28349262
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 4 Week β-alanine Supplementation on Knee Extensor Contractile and Force Properties in Active Male Adults (18-30 Years).
- ClinicalTrials.gov ID
- NCT02819505
- Acronym / sponsor ID
- 369
- Conditions
- Muscle Function
- Keywords
- beta-alanine, carnosine, neuromuscular, stimulation, skeletal muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Carnosine (β-alanyl-L-histidine) is a naturally occurring dipeptide formed by bonding histidine and β-alanine in a reaction catalysed by carnosine synthase. One role of carnosine within the human system, is as an intracellular pH buffer due to its pKa of 6.83. Carnosine is suitable over the whole exercise induced intramuscular pH transit-range. Carnosine in untrained populations can neutralise 2.4 to 10.1mmol H+.kg-1 of dry mass muscle as intramuscular pH declines, adding at least 7% to 10% to total intramuscular buffering capacity. It has also been argued that carnosine in combination with anserine can contribute as much as 40% to the buffering capacity between pH ranges of 6.5 to 7.5. β-alanine has been suggested as the rate limiting factor for muscle carnosine synthesis, through ingestion of β-alanine in diet (meat, fish and poultry) or via short-term supplementation, demonstrating significant increases in muscle carnosine concentrations. Increases in carnosine concentrations between 40% and 80% have been shown, depending upon dose (between 3.2 and 6.4 g·d-1) and duration of administration (between 4 and 10 weeks). Increasing β-alanine concentrations therefore enhance carnosine synthesis with the muscle fibers and improves intramuscular buffering capacity. Exercise performance and capacity measurements that previously were limited by the accumulation of H+ have been demonstrated significant improvements through supplementation with β-alanine.
Research already conducted at Nottingham Trent University and approved by this ethical advisory committee has demonstrated no significant effect of β-alanine supplementation on neuromuscular performance in healthy, active males. However, this research was conducted with well rested participants, with no prior exercise or fatigue of the assessed muscle; therefore there was no accumulation of H+ demonstrated within the muscle. These previous investigations are therefore contemplating how β-alanine supplementation alters performance when intramuscular buffering has not been altered (at the start of the exercise), whereas the proposed study will examine the effect of β-alanine supplementation on performance when intramuscular pH has already been challenged (due to fatiguing exercise). It is hypothesised that β-alanine supplementation over 4 weeks will beneficially alter the contractile and force properties of the muscle fibres within the lower limb muscles, improving physical performance when the muscle is already fatigued.
Aims of the project:
To examine the effects of 4 week β-alanine supplementation on knee extensor contractile and force properties, pre and post induced muscle specific fatigue in 18-30 year old males.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-alanine supplementation | Experimental | Dietary Supplement: beta-alanineParticipants 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). |
| Placebo supplementation | Placebo comparator | Dietary Supplement: PlaceboParticipants will be supplemented with 6.4g·d-1 placebo (maltodextrin; NAI, USA). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- physically active
- male
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beta-alanine | Dietary supplement | Beta-alanine supplementation |
| Placebo | Dietary supplement | Placebo supplementation |
Primary outcome
Half relaxation time
Time frame: 4 weeks
The time taken to decline to 50% maximum following a evoked twitch contraction
5 secondary outcomes
Force frequency relationship
Time frame: 4 weeks
Time to peak tension
Time frame: 4 weeks
Electromechanical delay
Time frame: 4 weeks
Maximal voluntary force production
Time frame: 4 weeks
Explosive voluntary force production
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Background: PubMed 20091069Sale 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.
- Background: PubMed 23479117Sale 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.
- Background: PubMed 23075550Harris 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.
- Background: PubMed 20479615Artioli 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.
- Derived from this study: PubMed 28349262Jones 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing beta-alanine in people with Muscle Function, run by Nottingham Trent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Half relaxation time (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819505, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.