Muscle DamageNCT03766815
Effect of Branched-chain Amino Acid Supplementation on Muscle Damage
A study testing BCAA 200mg/kg/day, BCAA 400mg/kg/day and Muscle damaging exercise in people with Muscle Damage, run by Western University, Canada at 1 site in Canada.
Trial summary
Seventy-eight recreational athletes who never resistance trained will be randomly assigned into three groups of twenty-six. Branched-chain amino acid will be supplemented for 18days at 0, 200 or 400 mg/body weight(kg)/day in jelly. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- BCAA 200mg/kg/day, BCAA 400mg/kg/day and Muscle damaging exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 31 Dec 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females at the age of 18-40
- Endurance trained athletes
- Weekly exercise duration is less than 150minutes but more than 30 minutes
Who cannot join
- Individuals who cannot endure three days for not eating meat
- Diabetic
- Have been performing resistance trainings
- Have been taking protein supplement
- Have been consuming a high level of protein in the regular diet
- Have been taking omega-three and vitamin E supplements
Show all 11Show fewer
- Have been taking anabolic Steroids
- Have been taking regular medications
- Have cardiovascular Disease
- Have a history of joint \& Muscle Injuries
- Females with irregular Menstrual Cycle
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Exercise Nutrition Laboratory (Western University)
London, Ontario, N6A 3K7
Peter Lemon, PhD, 519 6612111 ext. 88139, plemon@uwo.ca
About this study
Official title: Effect of Branched-chain Amino Acid Supplementation on Muscle Damage in Recreational Athletes
Seventy-eight recreational athletes who never resistance trained will be randomly assigned into three groups of twenty-six. Branched-chain amino acid will be supplemented for 18days at 0, 200 or 400 mg/body weight(kg)/day in jelly. Participants will be asked to perform elbow flexions on the 12th day of supplementation. Maximum voluntary contractions will be measured before, during and after the supplementation period to compare the effects of different doses of branched-chain amino acid has on muscle damage markers.
Read the detailed description
Previous studies have not been able to show consistent effects due to various reasons. The major limitations are the lack of enough data on the amount and duration of branched-chain amino acid supplementation, and the level of muscle damage for branched-chain amino acid to be effective. Based on a recent meta-analysis, it has been suggested that to be effective, branched-chain amino acid should be supplemented more than 200mg/kg/day before a low-to-moderate intensity exercise bout. Therefore, this study is designed based on the above suggestions and to compare the effect of different doses of branched-chain amino acid on muscle damage markers in healthy recreational active individuals.
Three treatment groups (n=26) will be randomly assigned to be supplemented with either 200mg BCAA/kg/day (BCAA200), 400mg BCAA/kg/day (BCAA400) or placebo (fiber supplement; PL). Supplements will be provided in jelly in a single blind fashion to be ingested 1hour after each of the three main daily meals for 18days. Anthropometric measurements (body weight, lean mass, height), body temperature, ultrasound (US), strength assessment (maximal voluntary contraction, MVC), resting metabolic rate (RMR), rate of perceived exertion (RPE), delayed onset of muscle soreness (DOMS) and blood samples (duplicates; myoglobin; BCAA) will be collected before, during and after the supplementation period at different time points (see appendix for the above tables). Repeated-bout effect (RBE) on both arms will be measured 7 days after the damage inducing session.
- Conditions
- Muscle Damage
- Being tested
- BCAA 200mg/kg/day, Placebo, BCAA 400mg/kg/day, Muscle damaging exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAA 200mg/kg/dayDietary supplement
BCAA supplement based on 200mg/kg/day for 18 days.
PlaceboDietary supplement
Fiber supplement jelly for 18 days.
BCAA 400mg/kg/dayDietary supplement
BCAA supplement based on 400mg/kg/day for 18 days.
Muscle damaging exerciseBehavioural
Participants will be asked to perform muscle damaging elbow eccentric contraction exercise at 120% of 1RM for three sets of 15 repetitions with the dominant arm at maximal effort on a Biodex machine with a 3 minute rest period between each set.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Fiber supplement mixed with jelly will be ingested for 18 days with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation. Receives: Dietary Supplement: Placebo; Behavioral: Muscle damaging exercise |
| BCAA 200mg/kg/day | Experimental | Branched-chain amino acid supplement mixed with jelly will be ingested for 18 days. The amount of supplement provided will be based on body weight (200mg/kg/day) with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation. Receives: Dietary Supplement: BCAA 200mg/kg/day; Behavioral: Muscle damaging exercise |
| BCAA 400mg/kg/day | Experimental | Branched-chain amino acid supplement mixed with jelly will be ingested for 18 days. The amount of supplement provided will be based on body weight (400mg/kg/day) with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation. Receives: Dietary Supplement: BCAA 400mg/kg/day; Behavioral: Muscle damaging exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum voluntary contraction (MVC)
Participants will be asked to perform three repetitions of concentric elbow flexion at their maximal force (1RM) with both their dominant and non-dominant arm on an isokinetic dynamometer (Biodex).
Measured: baseline (before supplementation) and at 1,3,24,48,72,96,120,144 hours after muscle damage
Secondary outcomes (9)
Change in blood myoglobin
Blood myoglobin will be measured with Enzyme-Linked Immunosorbent Assay.
Measured: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in 3-methyl-histidine
Ultra-performance liquidchromatography tandem mass spectrometry (UPLC-MS/MS) using an Acquity Ultra Performance LC system coupled to a Waters Quattro Premier XE mass spectrometer (bothWaters Corporation, Milford, MA, USA) and the Waters MassLynx Software (Version 4.1).
Measured: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Changes in insulin
Blood insulin will be measured with a standard insulin radioimmunoassay kit.
Measured: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in muscle soreness
Perceived muscle soreness will be determined by asking participants to stand in the anatomical position while flexing the shoulder of the exercised arm at 90degrees and fully extending the elbow. Participants will be asked to determine their forearm flexor muscles soreness with the use of a visual analogue scale (VAS) and rate from 1 being no pain and 10 being extremely painful.
Measured: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in ultrasound images of the arm muscles
Ultrasound measurements will be used to scan the triceps brachii and the forearm flexors. A permanent marker will be used to mark the elbow joint as the origin and both the belly of the triceps and the belly of the flexor digitorum profundus as the end point so as to compare the echoic difference in both the upper and lower arms.
Measured: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in limb girth
Limb girth of the upper arm (between the lateral epicondyle of the humerus and the acromion process) and the lower arm (between the lateral epicondyle of the humerus and the styloid process of the radius) will be measured with an anthropometric tape when the arm is naturally hanging down.
Measured: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in body temperature
Body temperature will be measured with an ear thermometer
Measured: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in resting metabolic rate
Resting metabolic rate will be measured with a metabolic cart
Measured: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in range of motion
Range of motion of the arm will be measured by asking the participant to stand in the anatomical position while fully flexing the shoulder of the exercised arm and then extending the elbow to an angle that they do not feel any pain in the arms. A goniometer will be used to measure the angles.
Measured: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Oct 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be supplemented for 18 days with either 200mg BCAA/kg/day, 400mg BCAA/kg/day or placebo (fiber supplement) in jelly in a single-blind fashion. Followed by a muscle damaging exercise and subsequent MVC and blood sample for force and metabolite measurements.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, Western University, Canada
- Investigators
- Peter Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766815
- Sponsor's protocol ID
- 113281
- Status last verified
- Sep 2019
- First submitted
- 3 Dec 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Branched-chain Amino Acid Supplementation on Muscle Damage in Recreational Athletes
- ClinicalTrials.gov ID
- NCT03766815
- Acronym / sponsor ID
- 113281
- Conditions
- Muscle Damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Dec 2018 (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.
Seventy-eight recreational athletes who never resistance trained will be randomly assigned into three groups of twenty-six. Branched-chain amino acid will be supplemented for 18days at 0, 200 or 400 mg/body weight(kg)/day in jelly. Participants will be asked to perform elbow flexions on the 12th day of supplementation. Maximum voluntary contractions will be measured before, during and after the supplementation period to compare the effects of different doses of branched-chain amino acid has on muscle damage markers.
Detailed description
Previous studies have not been able to show consistent effects due to various reasons. The major limitations are the lack of enough data on the amount and duration of branched-chain amino acid supplementation, and the level of muscle damage for branched-chain amino acid to be effective. Based on a recent meta-analysis, it has been suggested that to be effective, branched-chain amino acid should be supplemented more than 200mg/kg/day before a low-to-moderate intensity exercise bout. Therefore, this study is designed based on the above suggestions and to compare the effect of different doses of branched-chain amino acid on muscle damage markers in healthy recreational active individuals.
Three treatment groups (n=26) will be randomly assigned to be supplemented with either 200mg BCAA/kg/day (BCAA200), 400mg BCAA/kg/day (BCAA400) or placebo (fiber supplement; PL). Supplements will be provided in jelly in a single blind fashion to be ingested 1hour after each of the three main daily meals for 18days. Anthropometric measurements (body weight, lean mass, height), body temperature, ultrasound (US), strength assessment (maximal voluntary contraction, MVC), resting metabolic rate (RMR), rate of perceived exertion (RPE), delayed onset of muscle soreness (DOMS) and blood samples (duplicates; myoglobin; BCAA) will be collected before, during and after the supplementation period at different time points (see appendix for the above tables). Repeated-bout effect (RBE) on both arms will be measured 7 days after the damage inducing session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be supplemented for 18 days with either 200mg BCAA/kg/day, 400mg BCAA/kg/day or placebo (fiber supplement) in jelly in a single-blind fashion. Followed by a muscle damaging exercise and subsequent MVC and blood sample for force and metabolite measurements.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Muscle damaging exerciseFiber supplement mixed with jelly will be ingested for 18 days with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation. |
| BCAA 200mg/kg/day | Experimental | Dietary Supplement: BCAA 200mg/kg/day, Behavioral: Muscle damaging exerciseBranched-chain amino acid supplement mixed with jelly will be ingested for 18 days. The amount of supplement provided will be based on body weight (200mg/kg/day) with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation. |
| BCAA 400mg/kg/day | Experimental | Dietary Supplement: BCAA 400mg/kg/day, Behavioral: Muscle damaging exerciseBranched-chain amino acid supplement mixed with jelly will be ingested for 18 days. The amount of supplement provided will be based on body weight (400mg/kg/day) with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females at the age of 18-40
- Endurance trained athletes
- Weekly exercise duration is less than 150minutes but more than 30 minutes
Key exclusion criteria (11 listed)
- Individuals who cannot endure three days for not eating meat
- Diabetic
- Have been performing resistance trainings
- Have been taking protein supplement
- Have been consuming a high level of protein in the regular diet
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 |
|---|---|---|
| BCAA 200mg/kg/dayBCAA supplement based on 200mg/kg/day for 18 days. | Dietary supplement | BCAA 200mg/kg/day |
| PlaceboFiber supplement jelly for 18 days. | Dietary supplement | Placebo |
| BCAA 400mg/kg/dayBCAA supplement based on 400mg/kg/day for 18 days. | Dietary supplement | BCAA 400mg/kg/day |
| Muscle damaging exerciseParticipants will be asked to perform muscle damaging elbow eccentric contraction exercise at 120% of 1RM for three sets of 15 repetitions with the dominant arm at maximal effort on a Biodex machine with a 3 minute rest period between each set. | Behavioural | BCAA 200mg/kg/day, BCAA 400mg/kg/day, Placebo |
Primary outcome
Change in maximum voluntary contraction (MVC)
Time frame: baseline (before supplementation) and at 1,3,24,48,72,96,120,144 hours after muscle damage
Participants will be asked to perform three repetitions of concentric elbow flexion at their maximal force (1RM) with both their dominant and non-dominant arm on an isokinetic dynamometer (Biodex).
9 secondary outcomes
Change in blood myoglobin
Time frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in 3-methyl-histidine
Time frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Changes in insulin
Time frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in muscle soreness
Time frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in ultrasound images of the arm muscles
Time frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in limb girth
Time frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in body temperature
Time frame: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in resting metabolic rate
Time frame: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Change in range of motion
Time frame: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- 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.
Peter Lemon, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA 200mg/kg/day, BCAA 400mg/kg/day and Muscle damaging exercise in people with Muscle Damage, run by Western University, Canada at 1 site in Canada.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Crystal Lee, BSc (519 6612111, plee263@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum voluntary contraction (MVC) (time frame: baseline (before supplementation) and at 1,3,24,48,72,96,120,144 hours after muscle damage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2019.