<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/NCT01722448</url>
  </required_header>
  <id_info>
    <org_study_id>12-0504</org_study_id>
    <nct_id>NCT01722448</nct_id>
  </id_info>
  <brief_title>Nutritional Prevention of Exertional Muscle Dysfunction</brief_title>
  <acronym>MUSREC</acronym>
  <official_title>Nutritional Prevention of Exertional Muscle Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to find out whether a choline supplement can protect muscle health in&#xD;
      young men with very common genetic vulnerabilities. Men, who respond to a brief, but intense&#xD;
      set of arm exercise and have a common genetic profile, will be asked to use a choline&#xD;
      supplement for three weeks and a placebo for three weeks. Before the begin of the&#xD;
      supplementation study and after 3 and 6 weeks the investigators will test response to the&#xD;
      exercise challenge and ask that all consumed foods are recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An initial screening questionnaire will determine general eligibility. The investigators will&#xD;
      screen white young males with low to moderate choline intake (&lt;450 mg/d) for CK response to&#xD;
      exercise (high/low) by having them do intense eccentric exercise (12 elbow flexor&#xD;
      contractions of non-dominant arm with dumbbell at 100% maximal lift capacity) and then 72&#xD;
      hours (3 days) later draw 250 μl capillary blood by finger stick for CK, metabolomic and&#xD;
      genetic measurements.&#xD;
&#xD;
      The investigators plan to recruit 30 CK responders with an 1958 A allele of the&#xD;
      methylenetetrahydrofolate dehydrogenase 1 (MTHFD1), which is present in about 60% of&#xD;
      Caucasian males.&#xD;
&#xD;
      All participants will be asked to complete on three days 24-hour diet interviews with an&#xD;
      online automated program provided by the National Cancer Institute. Participants of the&#xD;
      intervention study will also have to be complete interviews on the final three days of the&#xD;
      two intervention periods The recruited candidates will do an initial exercise challenge with&#xD;
      no intervention, then a second challenge after three weeks with the first supplement&#xD;
      (randomized choline or placebo), then a third challenge after another three weeks with the&#xD;
      complementary second supplement (choline if they had placebo first, placebo if they had&#xD;
      choline first).&#xD;
&#xD;
      Samples identified only by code will be stored indefinitely at the UNC Nutrition Research&#xD;
      Institute to permit the analysis of additional genetic markers related to muscle health and&#xD;
      choline metabolism when the capacity for the analysis of such markers becomes available. Such&#xD;
      analyses may be carried out at the University of North Carolina Nutrition Research Institute&#xD;
      (UNC NRI) or at external laboratories providing the service for the PI. Samples will be&#xD;
      destroyed once no such additional analyses are intended or feasible anymore or if the&#xD;
      investigators do not continue this research. Storage of the samples is not optional.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Creatine Kinase (CK) activity</measure>
    <time_frame>3 weeks</time_frame>
    <description>CK activity in response to an exertional challenge will be measured.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Muscle Dysfunction</condition>
  <condition>Exertional Rhabdomyolysis</condition>
  <condition>Muscle Strength</condition>
  <arm_group>
    <arm_group_label>Choline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phosphatidyl choline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vegetable oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Choline</intervention_name>
    <description>4 capsules with 480 mg choline per day</description>
    <arm_group_label>Choline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  choline intake less than 450 mg&#xD;
&#xD;
          -  exertional muscle dysfunction&#xD;
&#xD;
          -  susceptible genetic profile&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe chronic illness&#xD;
&#xD;
          -  limited range of arm motion&#xD;
&#xD;
          -  required use of prescription medication&#xD;
&#xD;
          -  required use of dietary supplements&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Kohlmeier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Nutrition Research Institute</name>
      <address>
        <city>Kannapolis</city>
        <state>North Carolina</state>
        <zip>28081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>October 12, 2017</last_update_submitted>
  <last_update_submitted_qc>October 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>muscle</keyword>
  <keyword>muscle dysfunction</keyword>
  <keyword>choline</keyword>
  <keyword>exercise</keyword>
  <keyword>exertional rhabdomyolysis</keyword>
  <keyword>rhabdomyolysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhabdomyolysis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choline</mesh_term>
  </intervention_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/NCT01722448
org study id: 12-0504
nct id: NCT01722448
lead sponsor: 
has dmc: No
The investigators want to find out whether a choline supplement can protect muscle health in
      young men with very common genetic vulnerabilities. Men, who respond to a brief, but intense
      set of arm exercise and have a common genetic profile, will be asked to use a choline
      supplement for three weeks and a placebo for three weeks. Before the begin of the
      supplementation study and after 3 and 6 weeks the investigators will test response to the
      exercise challenge and ask that all consumed foods are recorded.
An initial screening questionnaire will determine general eligibility. The investigators will
      screen white young males with low to moderate choline intake (<450 mg/d) for CK response to
      exercise (high/low) by having them do intense eccentric exercise (12 elbow flexor
      contractions of non-dominant arm with dumbbell at 100% maximal lift capacity) and then 72
      hours (3 days) later draw 250 μl capillary blood by finger stick for CK, metabolomic and
      genetic measurements.

      The investigators plan to recruit 30 CK responders with an 1958 A allele of the
      methylenetetrahydrofolate dehydrogenase 1 (MTHFD1), which is present in about 60% of
      Caucasian males.

      All participants will be asked to complete on three days 24-hour diet interviews with an
      online automated program provided by the National Cancer Institute. Participants of the
      intervention study will also have to be complete interviews on the final three days of the
      two intervention periods The recruited candidates will do an initial exercise challenge with
      no intervention, then a second challenge after three weeks with the first supplement
      (randomized choline or placebo), then a third challenge after another three weeks with the
      complementary second supplement (choline if they had placebo first, placebo if they had
      choline first).

      Samples identified only by code will be stored indefinitely at the UNC Nutrition Research
      Institute to permit the analysis of additional genetic markers related to muscle health and
      choline metabolism when the capacity for the analysis of such markers becomes available. Such
      analyses may be carried out at the University of North Carolina Nutrition Research Institute
      (UNC NRI) or at external laboratories providing the service for the PI. Samples will be
      destroyed once no such additional analyses are intended or feasible anymore or if the
      investigators do not continue this research. Storage of the samples is not optional.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Creatine Kinase (CK) activity
time frame: 3 weeks
description: CK activity in response to an exertional challenge will be measured.
arm group label: Choline
arm group type: Experimental
description: Phosphatidyl choline
arm group label: Placebo
arm group type: Placebo Comparator
description: Vegetable oil
intervention type: Dietary Supplement
intervention name: Choline
description: 4 capsules with 480 mg choline per day
arm group label: Choline
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Kohlmeier, MD
role: Principal Investigator
affiliation: University of North Carolina
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rhabdomyolysis
mesh term: Choline