Exercise-induced Muscle DamageNCT01529281
Exercise-induced Muscle Damage is Reduced in Resistance Trained Athletes by Branch Chain Amino Acids
A study testing Branch Chain Amino Acid (BCAA) in people with Exercise-induced Muscle Damage, run by Northumbria University.
Trial summary
It is well documented that exercise-induced muscle damage (EIMD) decreases muscle function and causes severe soreness and discomfort. Branched-chain amino acid (BCAA) supplementation has been shown to increase protein synthesis and decrease muscle protein breakdown, however, the effects of BCAAs on recovery from EIMD… 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
- Exercise-induced Muscle Damage
- What is being tested?
- Branch Chain Amino Acid (BCAA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Sep 2011
- Phase
- Interventional
- 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
- Resistance trained males
Who cannot join
- Muscular skeletal disorders
About this study
It is well documented that exercise-induced muscle damage (EIMD) decreases muscle function and causes severe soreness and discomfort. Branched-chain amino acid (BCAA) supplementation has been shown to increase protein synthesis and decrease muscle protein breakdown, however, the effects of BCAAs on recovery from EIMD are unknown. Thus, the aim of this study was to examine the effects of a BCAA supplement on markers of muscle damage.
- Conditions
- Exercise-induced Muscle Damage
- Being tested
- Branch Chain Amino Acid (BCAA), Placebo - asparmate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branch Chain Amino Acid (BCAA)Dietary supplement
Supplementation lasted for a total of 12 days; this was based on previous research showing a positive with BCAA supplementation on markers of muscle damage. Participants ingested 10 g, twice per day (morning and evening) of BCAA . The BCAA supplement contained a ratio of 2:1:1 (leucine, isoleucine and valine, respectively). The BCAA was in powder form where each serving was mixed with ~300 ml of water.
Placebo - asparmateDietary supplement
Supplementation lasted for a total of 12 days. Participants ingested an equivalent looking volume to 10 g of BCAA, twice per day (morning and evening) of placebo (aspartame based artificial sweetener). The BCAA supplement contained a ratio of 2:1:1 (leucine, isoleucine and valine, respectively). The artificial sweetener was in powder form where each serving was mixed with ~300 ml of water.
| Study group | Role | What they receive |
|---|---|---|
| BCAA | Experimental | Branched chain amino acid Receives: Dietary Supplement: Branch Chain Amino Acid (BCAA) |
| Asparmate | Placebo comparator | Placebo control containing no protein or carbohydrate Receives: Dietary Supplement: Placebo - asparmate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary contraction
Isometric MVC of the participants' dominant knee extensors was assessed using a strain gauge. MVCs were performed for 3 s with a 60 s rest between each repetition.
Measured: pre exercise, 24 h, 48 h, 72 h, 96 h post-exercise
Secondary outcomes (4)
Limb girths
Mid-thigh and calf circumference was assessed as a measure of limb swelling using an anthropometric tape measure. Both measures were obtained with the participant in a standing position.
Measured: pre-exercise, 24h, 48h, 72h, 96h
Vertical jump
Vertical jump (VJ) performance was assessed using the Vertec instrument. Participants performed a counter movement jump.
Measured: pre-exercise, 24h, 48h, 72h, 96h
Creatine kinase
Plasma CK was determined from an earlobe capillary blood sample. The sample (30 microlitres) was analysed immediately using an automated, dry slide photospectrometer.
Measured: pre-exercise, 24h, 48h, 72h, 96h
Muscle soreness
Muscle soreness - Participants were asked to perform and hold a squat (90° knee angle) whilst they rated their perceived muscle soreness on a 200 mm visual analogue scale. The scale consisted of a line from 0 mm (no pain) to 200 mm (unbearably painful).
Measured: pre-exercise, 24h, 48h, 72h, 96h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise-induced Muscle DamageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glyn Howatson, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529281
- Sponsor's protocol ID
- Northumbria_How_BCAA
- Status last verified
- Feb 2012
- First submitted
- 2 Feb 2012
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Howatson G, Hoad M, Goodall S, Tallent J, Bell PG, French DN. Exercise-induced muscle damage is reduced in resistance-trained males by branched chain amino acids: a randomized, double-blind, placebo controlled study. J Int Soc Sports Nutr. 2012 Jul 12;9:20. doi: 10.1186/1550-2783-9-20. eCollection 2012.
PubMed 22569039
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced Muscle Damage is Reduced in Resistance Trained Athletes by Branch Chain Amino Acids
- ClinicalTrials.gov ID
- NCT01529281
- Acronym / sponsor ID
- Northumbria_How_BCAA
- Conditions
- Exercise-induced Muscle Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Feb 2012 (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.
It is well documented that exercise-induced muscle damage (EIMD) decreases muscle function and causes severe soreness and discomfort. Branched-chain amino acid (BCAA) supplementation has been shown to increase protein synthesis and decrease muscle protein breakdown, however, the effects of BCAAs on recovery from EIMD are unknown. Thus, the aim of this study was to examine the effects of a BCAA supplement on markers of muscle damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCAA | Experimental | Dietary Supplement: Branch Chain Amino Acid (BCAA)Branched chain amino acid |
| Asparmate | Placebo comparator | Dietary Supplement: Placebo - asparmatePlacebo control containing no protein or carbohydrate |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Resistance trained males
Key exclusion criteria (1 listed)
- Muscular skeletal disorders
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 |
|---|---|---|
| Branch Chain Amino Acid (BCAA)Supplementation lasted for a total of 12 days; this was based on previous research showing a positive with BCAA supplementation on markers of muscle damage. Participants ingested 10 g, twice per day (morning and evening) of BCAA . The BCAA supplement contained a ratio of 2:1:1 (leucine, isoleucine and valine, respectively). The BCAA was in powder form where each serving was mixed with ~300 ml of water. | Dietary supplement | BCAA |
| Placebo - asparmateSupplementation lasted for a total of 12 days. Participants ingested an equivalent looking volume to 10 g of BCAA, twice per day (morning and evening) of placebo (aspartame based artificial sweetener). The BCAA supplement contained a ratio of 2:1:1 (leucine, isoleucine and valine, respectively). The artificial sweetener was in powder form where each serving was mixed with ~300 ml of water. | Dietary supplement | Asparmate |
Primary outcome
Maximal voluntary contraction
Time frame: pre exercise, 24 h, 48 h, 72 h, 96 h post-exercise
Isometric MVC of the participants' dominant knee extensors was assessed using a strain gauge. MVCs were performed for 3 s with a 60 s rest between each repetition.
4 secondary outcomes
Limb girths
Time frame: pre-exercise, 24h, 48h, 72h, 96h
Vertical jump
Time frame: pre-exercise, 24h, 48h, 72h, 96h
Creatine kinase
Time frame: pre-exercise, 24h, 48h, 72h, 96h
Muscle soreness
Time frame: pre-exercise, 24h, 48h, 72h, 96h
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 8 Feb 2012.
- Derived from this study: PubMed 22569039Howatson G, Hoad M, Goodall S, Tallent J, Bell PG, French DN. Exercise-induced muscle damage is reduced in resistance-trained males by branched chain amino acids: a randomized, double-blind, placebo controlled study. J Int Soc Sports Nutr. 2012 Jul 12;9:20. doi: 10.1186/1550-2783-9-20. eCollection 2012.
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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.
Glyn Howatson, PhD principal investigator
Northumbria University
Questions about this trial
What is this clinical trial studying?
A study testing Branch Chain Amino Acid (BCAA) in people with Exercise-induced Muscle Damage, run by Northumbria 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: finished, as of the sponsor's last update on 8 Feb 2012. 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.
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?
Maximal voluntary contraction (time frame: pre exercise, 24 h, 48 h, 72 h, 96 h post-exercise). 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 NCT01529281, which also lists 1 linked publication.
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 8 Feb 2012.