<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/NCT01687361</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00449-34</org_study_id>
    <secondary_id>2012-04</secondary_id>
    <nct_id>NCT01687361</nct_id>
  </id_info>
  <brief_title>Can Branched Chain Amino Acids Supplementation Reduce Muscle Damage Induced by Neuromuscular Electrical Stimulation? A Combined Functional and Metabolic Non-invasive Investigation in Healthy Humans</brief_title>
  <official_title>Can Branched Chain Amino Acids Supplementation Reduce Muscle Damage Induced by Neuromuscular Electrical Stimulation ? A Combined Functional and Metabolic Non-invasive Investigation in Healthy Humans.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in&#xD;
      order to increase or restore muscle capacities of hypoactive patients or patients with&#xD;
      articular trauma. Although this technique seems to be particularly adapted to muscle&#xD;
      rehabilitation, growing evidence is emerging regarding potential damaging effects of&#xD;
      electrically- induced isometric contractions in healthy humans. Recent studies have reported&#xD;
      a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased&#xD;
      muscle soreness and impaired force production as a result of NMESs. On that basis, further&#xD;
      studies should be conducted on these deleterious effects which might limit the clinical&#xD;
      application of NMES.&#xD;
&#xD;
      Over the last decade, many studies paid attention to branched-chain amino acids (BCAA)&#xD;
      supplementation as a potential prophylactic/therapeutic approach. The rationale of this&#xD;
      approach is that BCAA might increase protein synthesis and reduce protein breakdown through&#xD;
      physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin).&#xD;
      Additionally, BCAA could also be used as energetic substrate during exercise when glycogen&#xD;
      stores are depleted. Overall, previous results have supported the efficacy of BCAA&#xD;
      supplementation in attenuating muscle damage. Nevertheless, comprehensive studies&#xD;
      investigating the effect of amino acid supplementation on markers of muscle damage are still&#xD;
      scarce.&#xD;
&#xD;
      Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS)&#xD;
      are powerful non invasive tools allowing the exploration of skeletal muscle structure and&#xD;
      energy metabolism.&#xD;
&#xD;
      This ambitious project is devoted to the anatomical, functional and metabolic&#xD;
      characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers of&#xD;
      muscle damage, including maximal voluntary force production, T2 values and apparent diffusion&#xD;
      coefficient (obtained by MRI) and energy metabolism assessed at rest and during exercise&#xD;
      (using 31P-MRS), will be obtained before and after NMES. This project is of utmost importance&#xD;
      for improving our knowledge of anatomic, metabolic and functional events related to BCAA&#xD;
      supplementation in the context of exercise-induced muscle damage&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>evaluation of the muscular responsiveness</measure>
    <time_frame>24 MONTHS</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation of the effects of a supplementation in AAB</measure>
    <time_frame>24 MONTTHS</time_frame>
    <description>on the physiological aspects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Neuromuscular Electrical Stimulation</condition>
  <arm_group>
    <arm_group_label>branched-chain amino acids (BCAA) supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PLACEBO</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>branched-chain amino acids (BCAA) supplementation</intervention_name>
    <arm_group_label>branched-chain amino acids (BCAA) supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PLACEBO</intervention_name>
    <arm_group_label>PLACEBO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Between 18 and 35 years&#xD;
&#xD;
          -  Subjects will have to be unhurt:&#xD;
&#xD;
               -  Any general disease&#xD;
&#xD;
               -  Psychiatric disorders(confusions)&#xD;
&#xD;
               -  Any infectious, inflammatory, tumoral, vascular, degenerative or traumatic&#xD;
                  pathology&#xD;
&#xD;
          -  They will have to follow no chronic treatment&#xD;
&#xD;
          -  They will have to be unhurt of any history of alcoholism or drug addiction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for an examination MRI&#xD;
&#xD;
          -  Suffering from claustrophobia&#xD;
&#xD;
          -  Having stimulating one cardiac, carriers of a system Holter, carriers of hook(staple)&#xD;
             (clip) surgical metallic, carriers of a prosthesis or a metallic implant (or quite&#xD;
             other metallic foreign bodies), carriers of a prosthesis dental (device), carriers of&#xD;
             a hearing aid, carriers of an insulin pump&#xD;
&#xD;
          -  Having been hurt by pieces of shrapnel or lead&#xD;
&#xD;
          -  Having had a dislocation, a fracture or a recent surgical operation (less than 6&#xD;
             months before the inclusion)&#xD;
&#xD;
          -  Having followed a treatment with anti-inflammatory drugs during the last 3 months&#xD;
&#xD;
          -  Having followed a treatment with amino acids during the last 3 months&#xD;
&#xD;
          -  Having followed a treatment(processing) with anabolic steroids during the last 3&#xD;
             months&#xD;
&#xD;
          -  Having participated in a program of body-building of lower limbs during the last 6&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BERNARD BELAIGUES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_official>
    <last_name>jean pierre mattei</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP HM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>June 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>August 29, 2014</last_update_submitted>
  <last_update_submitted_qc>August 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01687361
org study id: 2012-A00449-34
secondary id: 2012-04
nct id: NCT01687361
lead sponsor: 
has dmc: No
Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in
      order to increase or restore muscle capacities of hypoactive patients or patients with
      articular trauma. Although this technique seems to be particularly adapted to muscle
      rehabilitation, growing evidence is emerging regarding potential damaging effects of
      electrically- induced isometric contractions in healthy humans. Recent studies have reported
      a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased
      muscle soreness and impaired force production as a result of NMESs. On that basis, further
      studies should be conducted on these deleterious effects which might limit the clinical
      application of NMES.

      Over the last decade, many studies paid attention to branched-chain amino acids (BCAA)
      supplementation as a potential prophylactic/therapeutic approach. The rationale of this
      approach is that BCAA might increase protein synthesis and reduce protein breakdown through
      physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin).
      Additionally, BCAA could also be used as energetic substrate during exercise when glycogen
      stores are depleted. Overall, previous results have supported the efficacy of BCAA
      supplementation in attenuating muscle damage. Nevertheless, comprehensive studies
      investigating the effect of amino acid supplementation on markers of muscle damage are still
      scarce.

      Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS)
      are powerful non invasive tools allowing the exploration of skeletal muscle structure and
      energy metabolism.

      This ambitious project is devoted to the anatomical, functional and metabolic
      characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers of
      muscle damage, including maximal voluntary force production, T2 values and apparent diffusion
      coefficient (obtained by MRI) and energy metabolism assessed at rest and during exercise
      (using 31P-MRS), will be obtained before and after NMES. This project is of utmost importance
      for improving our knowledge of anatomic, metabolic and functional events related to BCAA
      supplementation in the context of exercise-induced muscle damage
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: evaluation of the muscular responsiveness
time frame: 24 MONTHS
measure: evaluation of the effects of a supplementation in AAB
time frame: 24 MONTTHS
description: on the physiological aspects
arm group label: branched-chain amino acids (BCAA) supplementation
arm group type: Experimental
arm group label: PLACEBO
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: branched-chain amino acids (BCAA) supplementation
arm group label: branched-chain amino acids (BCAA) supplementation
intervention type: Drug
intervention name: PLACEBO
arm group label: PLACEBO
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: BERNARD BELAIGUES
role: Study Director
affiliation: Assistance Publique hôpitaux de Marseille
last name: jean pierre mattei
role: Principal Investigator
affiliation: AP HM
facility: 
country: France
responsible party type: Sponsor