<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03766815</url>
  </required_header>
  <id_info>
    <org_study_id>113281</org_study_id>
    <nct_id>NCT03766815</nct_id>
  </id_info>
  <brief_title>Effect of Branched-chain Amino Acid Supplementation on Muscle Damage</brief_title>
  <official_title>Effect of Branched-chain Amino Acid Supplementation on Muscle Damage in Recreational Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Seventy-eight recreational athletes who never resistance trained will be randomly assigned&#xD;
      into three groups of twenty-six. Branched-chain amino acid will be supplemented for 18days at&#xD;
      0, 200 or 400 mg/body weight(kg)/day in jelly. Participants will be asked to perform elbow&#xD;
      flexions on the 12th day of supplementation. Maximum voluntary contractions will be measured&#xD;
      before, during and after the supplementation period to compare the effects of different doses&#xD;
      of branched-chain amino acid has on muscle damage markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have not been able to show consistent effects due to various reasons. The&#xD;
      major limitations are the lack of enough data on the amount and duration of branched-chain&#xD;
      amino acid supplementation, and the level of muscle damage for branched-chain amino acid to&#xD;
      be effective. Based on a recent meta-analysis, it has been suggested that to be effective,&#xD;
      branched-chain amino acid should be supplemented more than 200mg/kg/day before a&#xD;
      low-to-moderate intensity exercise bout. Therefore, this study is designed based on the above&#xD;
      suggestions and to compare the effect of different doses of branched-chain amino acid on&#xD;
      muscle damage markers in healthy recreational active individuals.&#xD;
&#xD;
      Three treatment groups (n=26) will be randomly assigned to be supplemented with either 200mg&#xD;
      BCAA/kg/day (BCAA200), 400mg BCAA/kg/day (BCAA400) or placebo (fiber supplement; PL).&#xD;
      Supplements will be provided in jelly in a single blind fashion to be ingested 1hour after&#xD;
      each of the three main daily meals for 18days. Anthropometric measurements (body weight, lean&#xD;
      mass, height), body temperature, ultrasound (US), strength assessment (maximal voluntary&#xD;
      contraction, MVC), resting metabolic rate (RMR), rate of perceived exertion (RPE), delayed&#xD;
      onset of muscle soreness (DOMS) and blood samples (duplicates; myoglobin; BCAA) will be&#xD;
      collected before, during and after the supplementation period at different time points (see&#xD;
      appendix for the above tables). Repeated-bout effect (RBE) on both arms will be measured 7&#xD;
      days after the damage inducing session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will not be able to distinguish branched-chain amino acid and fiber supplement by taste, color or scent as the supplements are provided in jelly.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in maximum voluntary contraction (MVC)</measure>
    <time_frame>baseline (before supplementation) and at 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in blood myoglobin</measure>
    <time_frame>10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>Blood myoglobin will be measured with Enzyme-Linked Immunosorbent Assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 3-methyl-histidine</measure>
    <time_frame>10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in insulin</measure>
    <time_frame>10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>Blood insulin will be measured with a standard insulin radioimmunoassay kit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in muscle soreness</measure>
    <time_frame>10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ultrasound images of the arm muscles</measure>
    <time_frame>10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in limb girth</measure>
    <time_frame>10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body temperature</measure>
    <time_frame>20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>Body temperature will be measured with an ear thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting metabolic rate</measure>
    <time_frame>20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>Resting metabolic rate will be measured with a metabolic cart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in range of motion</measure>
    <time_frame>20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Muscle Damage</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BCAA 200mg/kg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BCAA 400mg/kg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BCAA 200mg/kg/day</intervention_name>
    <description>BCAA supplement based on 200mg/kg/day for 18 days.</description>
    <arm_group_label>BCAA 200mg/kg/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Fiber supplement jelly for 18 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BCAA 400mg/kg/day</intervention_name>
    <description>BCAA supplement based on 400mg/kg/day for 18 days.</description>
    <arm_group_label>BCAA 400mg/kg/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Muscle damaging exercise</intervention_name>
    <description>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.</description>
    <arm_group_label>BCAA 200mg/kg/day</arm_group_label>
    <arm_group_label>BCAA 400mg/kg/day</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females at the age of 18-40&#xD;
&#xD;
          -  Endurance trained athletes&#xD;
&#xD;
          -  Weekly exercise duration is less than 150minutes but more than 30 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who cannot endure three days for not eating meat&#xD;
&#xD;
          -  Diabetic&#xD;
&#xD;
          -  Have been performing resistance trainings&#xD;
&#xD;
          -  Have been taking protein supplement&#xD;
&#xD;
          -  Have been consuming a high level of protein in the regular diet&#xD;
&#xD;
          -  Have been taking omega-three and vitamin E supplements&#xD;
&#xD;
          -  Have been taking anabolic Steroids&#xD;
&#xD;
          -  Have been taking regular medications&#xD;
&#xD;
          -  Have cardiovascular Disease&#xD;
&#xD;
          -  Have a history of joint &amp; Muscle Injuries&#xD;
&#xD;
          -  Females with irregular Menstrual Cycle&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Lemon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Crystal Lee, BSc</last_name>
    <phone>519 6612111</phone>
    <email>plee263@uwo.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arash Bandegan, PhD</last_name>
    <phone>519 6612111</phone>
    <email>abandeg@uwo.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Exercise Nutrition Laboratory (Western University)</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Lemon, PhD</last_name>
      <phone>519 6612111</phone>
      <phone_ext>88139</phone_ext>
      <email>plemon@uwo.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Peter Lemon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03766815
org study id: 113281
nct id: NCT03766815
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Other
masking: Single (Participant)
masking description: Participants will not be able to distinguish branched-chain amino acid and fiber supplement by taste, color or scent as the supplements are provided in jelly.
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
description: 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).
measure: 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
description: Blood myoglobin will be measured with Enzyme-Linked Immunosorbent Assay.
measure: 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
description: 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).
measure: 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
description: Blood insulin will be measured with a standard insulin radioimmunoassay kit.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: Body temperature will be measured with an ear thermometer
measure: 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
description: Resting metabolic rate will be measured with a metabolic cart
measure: 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
description: 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.
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
arm group label: BCAA 200mg/kg/day
arm group type: Experimental
description: 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.
arm group label: BCAA 400mg/kg/day
arm group type: Experimental
description: 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.
intervention type: Dietary Supplement
intervention name: BCAA 200mg/kg/day
description: BCAA supplement based on 200mg/kg/day for 18 days.
arm group label: BCAA 200mg/kg/day
intervention type: Dietary Supplement
intervention name: Placebo
description: Fiber supplement jelly for 18 days.
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: BCAA 400mg/kg/day
description: BCAA supplement based on 400mg/kg/day for 18 days.
arm group label: BCAA 400mg/kg/day
intervention type: Behavioral
intervention name: Muscle damaging exercise
description: 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.
arm group label: BCAA 200mg/kg/day
arm group label: BCAA 400mg/kg/day
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Lemon, PhD
role: Principal Investigator
affiliation: Western University
last name: Crystal Lee, BSc
phone: 519 6612111
email: plee263@uwo.ca
last name: Arash Bandegan, PhD
phone: 519 6612111
email: abandeg@uwo.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Peter Lemon
investigator title: Principal Investigator
sharing ipd: No