- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03766815
Effect of Branched-chain Amino Acid Supplementation on Muscle Damage
Effect of Branched-chain Amino Acid Supplementation on Muscle Damage in Recreational Athletes
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arash Bandegan, PhD
- Phone Number: 519 6612111
- Email: abandeg@uwo.ca
Study Locations
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Ontario
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London, Ontario, Canada, N6A 3K7
- Recruiting
- Exercise Nutrition Laboratory (Western University)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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.
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Fiber supplement jelly for 18 days.
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.
|
EXPERIMENTAL: BCAA 200mg/kg/day
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.
|
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.
BCAA supplement based on 200mg/kg/day for 18 days.
|
EXPERIMENTAL: BCAA 400mg/kg/day
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.
|
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.
BCAA supplement based on 400mg/kg/day for 18 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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baseline (before supplementation) and at 1,3,24,48,72,96,120,144 hours after muscle damage
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Blood myoglobin will be measured with Enzyme-Linked Immunosorbent Assay.
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10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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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
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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).
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10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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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
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Blood insulin will be measured with a standard insulin radioimmunoassay kit.
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10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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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
|
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.
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10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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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
|
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.
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10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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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
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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.
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10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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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
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Body temperature will be measured with an ear thermometer
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20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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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
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Resting metabolic rate will be measured with a metabolic cart
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20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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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
|
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.
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20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 113281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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