<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/NCT02253329</url>
  </required_header>
  <id_info>
    <org_study_id>MEC 14-3-042</org_study_id>
    <nct_id>NCT02253329</nct_id>
  </id_info>
  <brief_title>NMES During the Day and Prior to Sleep</brief_title>
  <acronym>ESPRO2</acronym>
  <official_title>The Effect of Neuromuscular Electrical Stimulation on Post-prandial Protein Accretion During the Day and Prior to Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the present study, the effect of a bolus of intrinsically labeled milk directly after&#xD;
      one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions:&#xD;
      during the day and prior to sleep&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present study, the effect of a bolus of intrinsically labeled milk directly after an&#xD;
      hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two&#xD;
      conditions: during the day and immediately prior to sleep&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incorporation of stable isotope amino acids into skeletal muscle tissue</measure>
    <time_frame>4-8 hours in the postprandial phase</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma amino acid enrichment</measure>
    <time_frame>4-8 hours in the postprandial phase</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Treatment during the day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neuromuscular electrical stimulation after a protein bolus, performed during the day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment prior to sleep</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Protein ingestion directly after one-legged NMES, directly prior to sleep</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dietary protein plus NMES during the day</intervention_name>
    <description>Neuromuscular electrical stimulation after a protein bolus, performed during the day</description>
    <arm_group_label>Treatment during the day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dietary protein plus NMES prior to sleep</intervention_name>
    <description>Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep</description>
    <arm_group_label>Treatment prior to sleep</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65-85 years&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  18.5 ≤ BMI ≤ 30.0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type II diabetes&#xD;
&#xD;
          -  All co morbidities interacting with mobility and muscle metabolism of the lower limbs&#xD;
             (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders,&#xD;
             paralysis, hip/knee surgery).&#xD;
&#xD;
          -  Use of anticoagulants, blood diseases, allergy for lidocaine&#xD;
&#xD;
          -  Use of NSAIDs (non-steroidal anti-inflammatory drugs) and acetylsalicylic acid&#xD;
&#xD;
          -  Patients suffering from PKU (Phenylketonuria)&#xD;
&#xD;
          -  Presence of implantable cardioverter defibrillator and/or pacemaker&#xD;
&#xD;
          -  Performed regular resistance type exercise in the past 6 months&#xD;
&#xD;
          -  Use of any tools to assist during walking (cane/ crutches/ walker)&#xD;
&#xD;
          -  (Partial) foot/ leg amputation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luc JC van Loon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Centre +</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>May 20, 2015</last_update_submitted>
  <last_update_submitted_qc>May 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuromuscular electrical stimulation</keyword>
  <keyword>Ageing</keyword>
  <keyword>Protein ingestion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02253329
org study id: MEC 14-3-042
nct id: NCT02253329
lead sponsor: 
has dmc: Yes
In the present study, the effect of a bolus of intrinsically labeled milk directly after
      one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions:
      during the day and prior to sleep
In the present study, the effect of a bolus of intrinsically labeled milk directly after an
      hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two
      conditions: during the day and immediately prior to sleep
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incorporation of stable isotope amino acids into skeletal muscle tissue
time frame: 4-8 hours in the postprandial phase
measure: Plasma amino acid enrichment
time frame: 4-8 hours in the postprandial phase
arm group label: Treatment during the day
arm group type: Active Comparator
description: Neuromuscular electrical stimulation after a protein bolus, performed during the day
arm group label: Treatment prior to sleep
arm group type: Active Comparator
description: Protein ingestion directly after one-legged NMES, directly prior to sleep
intervention type: Procedure
intervention name: Dietary protein plus NMES during the day
description: Neuromuscular electrical stimulation after a protein bolus, performed during the day
arm group label: Treatment during the day
intervention type: Procedure
intervention name: Dietary protein plus NMES prior to sleep
description: Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep
arm group label: Treatment prior to sleep
criteria: 
gender: Male
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luc JC van Loon, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Sarcopenia