Muscle FunctionPhase 4NCT03111979
The Effects of 4 Week β-alanine Supplementation on Knee Extensor Contractile and Force Properties in the Over 60s
A Phase 4 study testing beta-alanine in people with Muscle Function, run by Nottingham Trent University.
Trial summary
The older population is the fastest growing age group worldwide, but it is also the most susceptible to chronic diseases and disabilities. One of the most common negative consequences of aging is the decline in muscle mass, strength and power. This is most notable in lower limb muscles. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy 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
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Oct 2018
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants will be defined as 'medically stable' for exercise studies, as proposed by Grieg et al. (1994). This criteria was designed both for safety and to define degrees of freedom from diseases which might alter exercise performance (Greig et al., 1994).
Who cannot join
- Participants will be excluded if they are vegetarian/vegan or have been using β-alanine or creatine supplements within the past 6 months. They will also be excluded if they have participated in a resistance training programme in the last 6 months. These criteria will apply throughout the whole study, with any participants immediately excluded from the study if any of these medical conditions should arise.
About this study
The older population is the fastest growing age group worldwide, but it is also the most susceptible to chronic diseases and disabilities. One of the most common negative consequences of aging is the decline in muscle mass, strength and power. This is most notable in lower limb muscles. These muscles are required for the performance of daily activities including walking, stair climbing and standing up from sitting. Regular exercise is considered one of the most effective measures to slow, and even reverse the progression of muscle weakness. Nevertheless older adults may notice a decline in their capability to undertake regular exercises, this may be due to a decline in their muscle's ability to buffer pH. Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the extension of physical performance, counteracting the decline the muscle's ability to buffer pH. Yet this pH buffering process it largely restricted by the amount of β-alanine available in the human body. β-alanine is already known to decline in older individuals due to a reduction in food products (meat, fish and poultry). Yet through either consumption of β-alanine rich food, or through short-term supplementation, β-alanine is raised, increasing carnosine concentrations. Improved β-alanine levels can potentially advance exercise performance, for example significant improvements in time to exhaustion on both a constant (37%) and incremental (12%) treadmill tests have been demonstrated. It is therefore proposed that via β-alanine supplementation, an individual's perception of their frailty, maintenance of health and independent living can be improved in older individuals.
However, these findings are based on participants, both young and older, who are well-rested with no prior exercise or fatigue to the assessed muscles. It remains unclear if β-alanine supplementation will aid in the buffering of pH when the muscle has already been fatigued. 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.
- 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 4.8g·d-1 β-alanine (CarnoSyn™, NAI, USA). The β-alanine dosing regimen will consist of two 800 mg tablets three 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 | Placebo comparator | Participants will be supplemented with 4.8 g·d-1 placebo (maltodextrin; NAI, USA). The regimen will consist of two 800 mg tablets three times per day at 3-4 hour intervals the same regimen for beta-alanine tablets 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 posted13 Apr 2017
- Study startApr 2014
- Primary completionApr 2018 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: Time restrictions on leading investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Louise Jones, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111979
- Sponsor's protocol ID
- 343
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 20479615
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. 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 the Over 60s
- ClinicalTrials.gov ID
- NCT03111979
- Acronym / sponsor ID
- 343
- Conditions
- Muscle Function
- Keywords
- beta-alanine, Carnosine, Neuromuscular, Stimulation, Skeletal muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Time restrictions on leading investigator
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 13 Apr 2017 (actual)
- 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.
The older population is the fastest growing age group worldwide, but it is also the most susceptible to chronic diseases and disabilities. One of the most common negative consequences of aging is the decline in muscle mass, strength and power. This is most notable in lower limb muscles. These muscles are required for the performance of daily activities including walking, stair climbing and standing up from sitting. Regular exercise is considered one of the most effective measures to slow, and even reverse the progression of muscle weakness. Nevertheless older adults may notice a decline in their capability to undertake regular exercises, this may be due to a decline in their muscle's ability to buffer pH. Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the extension of physical performance, counteracting the decline the muscle's ability to buffer pH. Yet this pH buffering process it largely restricted by the amount of β-alanine available in the human body. β-alanine is already known to decline in older individuals due to a reduction in food products (meat, fish and poultry). Yet through either consumption of β-alanine rich food, or through short-term supplementation, β-alanine is raised, increasing carnosine concentrations. Improved β-alanine levels can potentially advance exercise performance, for example significant improvements in time to exhaustion on both a constant (37%) and incremental (12%) treadmill tests have been demonstrated. It is therefore proposed that via β-alanine supplementation, an individual's perception of their frailty, maintenance of health and independent living can be improved in older individuals.
However, these findings are based on participants, both young and older, who are well-rested with no prior exercise or fatigue to the assessed muscles. It remains unclear if β-alanine supplementation will aid in the buffering of pH when the muscle has already been fatigued. 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.
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 4.8g·d-1 β-alanine (CarnoSyn™, NAI, USA). The β-alanine dosing regimen will consist of two 800 mg tablets three 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 | Placebo comparator | Dietary Supplement: PlaceboParticipants will be supplemented with 4.8 g·d-1 placebo (maltodextrin; NAI, USA). The regimen will consist of two 800 mg tablets three times per day at 3-4 hour intervals the same regimen for beta-alanine tablets |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants will be defined as 'medically stable' for exercise studies, as proposed by Grieg et al. (1994). This criteria was designed both for safety and to define degrees of freedom from diseases which might alter exercise performance (Greig et al., 1994).
Key exclusion criteria (1 listed)
- Participants will be excluded if they are vegetarian/vegan or have been using β-alanine or creatine supplements within the past 6 months. They will also be excluded if they have participated in a resistance training programme in the last 6 months. These criteria will apply throughout the whole study, with any participants immediately excluded from the study if any of these medical conditions should arise.
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 |
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 13 Apr 2017. 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?
Results are not available in the source record.
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 NCT03111979, which also lists 4 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 13 Apr 2017.