<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/NCT01730521</url>
  </required_header>
  <id_info>
    <org_study_id>EK 2012-N-27</org_study_id>
    <nct_id>NCT01730521</nct_id>
  </id_info>
  <brief_title>The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation</brief_title>
  <official_title>The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Federal Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Iron metabolism may undergo changes during exercise, with reductions in classical iron status&#xD;
      markers due to a variety of postulated mechanism which include hemodilution, increased iron&#xD;
      loss, hemolysis and increased iron storage in muscles. Furthermore, it has been reported that&#xD;
      vigorous training increases hepcidin, a central regulatory peptide in iron metabolism. This&#xD;
      increase has been ascribed to the presence of subclinical inflammation. Increased hepcidin&#xD;
      levels may reduce iron bioavailability and iron incorporation in erythrocytes.&#xD;
&#xD;
      Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be&#xD;
      generally healthy, with no history of blood donation in the last 6 months, should weigh less&#xD;
      than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should&#xD;
      have familiarity to sports and running, but not currently (i.e. in the past 3 months)&#xD;
      training for more than 1h per week on average.&#xD;
&#xD;
      The aim of this study is to measure an iron bioavailability during a resting and an exercise&#xD;
      phase lasting approx. 14 days with training sessions on alternate days. Subjects will&#xD;
      participate in both restign and exercising protocols and act as their own controls during the&#xD;
      study. Iron bioavailability will be measured via the incorporation of stable isotopic labels&#xD;
      14 days after administration. To control for changes in blood volume during the course of the&#xD;
      study, blood volume of the participating subjects will be measured before and after the&#xD;
      exercise phase with the CO-rebreathing method.&#xD;
&#xD;
      Measurement of iron bioavailability and iron incorporation in a resting and exercising phase&#xD;
      will allow determine if the increased level of hepcidin seen in in exercise will induce a&#xD;
      lower iron bioavailability and iron incorporation during exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Iron bioavailability from Stable isotopic labels</measure>
    <time_frame>Up to 2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood volume increase during exercise</measure>
    <time_frame>Up to 2 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein)</measure>
    <time_frame>Up to 2 months</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Generally Healthy</condition>
  <arm_group>
    <arm_group_label>Difference in Iron bioavailabilty exercise and resting phase</arm_group_label>
    <description>the subjects will act as their own control during the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise (Running)</intervention_name>
    <description>the study foresees a measurement of iron biavailability in a resting and in a exercising phase and subjects will act as their own control during the study.</description>
    <arm_group_label>Difference in Iron bioavailabilty exercise and resting phase</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood and serum samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects studying or working at the University of Zürich or ETH Zürich&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men, Generally Healthy age between 18-50 years;&#xD;
&#xD;
          -  BMI between 18-25;&#xD;
&#xD;
          -  nonanemic (Hb &lt; 120 g/L);&#xD;
&#xD;
          -  no intake of vitamins and nutritional supplements;&#xD;
&#xD;
          -  no recent blood donation (&lt;4 months);&#xD;
&#xD;
          -  no previous participation in studies with stable iron isotopes in the past.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic diseases, Metabolic diseases, GI tract diseases (self reported)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diego Moretti, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ETH Zürich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ETH Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.humannutrition.ethz.ch/</url>
    <description>Laboratory of Human Nutrition, ETH Zürich</description>
  </link>
  <reference>
    <citation>Cercamondi CI, Egli IM, Ahouandjinou E, Dossa R, Zeder C, Salami L, Tjalsma H, Wiegerinck E, Tanno T, Hurrell RF, Hounhouigan J, Zimmermann MB. Afebrile Plasmodium falciparum parasitemia decreases absorption of fortification iron but does not affect systemic iron utilization: a double stable-isotope study in young Beninese women. Am J Clin Nutr. 2010 Dec;92(6):1385-92. doi: 10.3945/ajcn.2010.30051. Epub 2010 Oct 6. Erratum In: Am J Clin Nutr. 2015 Apr;101(4):894.</citation>
    <PMID>20926522</PMID>
  </reference>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 12, 2013</last_update_submitted>
  <last_update_submitted_qc>September 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Swiss Federal Institute of Technology</investigator_affiliation>
    <investigator_full_name>Prof. Michael B. Zimmermann</investigator_full_name>
    <investigator_title>Professor, MD</investigator_title>
  </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/NCT01730521
org study id: EK 2012-N-27
nct id: NCT01730521
lead sponsor: 
has dmc: No
Iron metabolism may undergo changes during exercise, with reductions in classical iron status
      markers due to a variety of postulated mechanism which include hemodilution, increased iron
      loss, hemolysis and increased iron storage in muscles. Furthermore, it has been reported that
      vigorous training increases hepcidin, a central regulatory peptide in iron metabolism. This
      increase has been ascribed to the presence of subclinical inflammation. Increased hepcidin
      levels may reduce iron bioavailability and iron incorporation in erythrocytes.

      Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be
      generally healthy, with no history of blood donation in the last 6 months, should weigh less
      than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should
      have familiarity to sports and running, but not currently (i.e. in the past 3 months)
      training for more than 1h per week on average.

      The aim of this study is to measure an iron bioavailability during a resting and an exercise
      phase lasting approx. 14 days with training sessions on alternate days. Subjects will
      participate in both restign and exercising protocols and act as their own controls during the
      study. Iron bioavailability will be measured via the incorporation of stable isotopic labels
      14 days after administration. To control for changes in blood volume during the course of the
      study, blood volume of the participating subjects will be measured before and after the
      exercise phase with the CO-rebreathing method.

      Measurement of iron bioavailability and iron incorporation in a resting and exercising phase
      will allow determine if the increased level of hepcidin seen in in exercise will induce a
      lower iron bioavailability and iron incorporation during exercise.
observational model: Case-Only
time perspective: Prospective
measure: Iron bioavailability from Stable isotopic labels
time frame: Up to 2 months
measure: Blood volume increase during exercise
time frame: Up to 2 months
measure: Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein)
time frame: Up to 2 months
arm group label: Difference in Iron bioavailabilty exercise and resting phase
description: the subjects will act as their own control during the study
intervention type: Behavioral
intervention name: Exercise (Running)
description: the study foresees a measurement of iron biavailability in a resting and in a exercising phase and subjects will act as their own control during the study.
arm group label: Difference in Iron bioavailabilty exercise and resting phase
Whole blood and serum samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Diego Moretti, PhD
role: Principal Investigator
affiliation: ETH Zürich
facility: 
country: Switzerland
url: http://www.humannutrition.ethz.ch/
description: Laboratory of Human Nutrition, ETH Zürich
citation: Cercamondi CI, Egli IM, Ahouandjinou E, Dossa R, Zeder C, Salami L, Tjalsma H, Wiegerinck E, Tanno T, Hurrell RF, Hounhouigan J, Zimmermann MB. Afebrile Plasmodium falciparum parasitemia decreases absorption of fortification iron but does not affect systemic iron utilization: a double stable-isotope study in young Beninese women. Am J Clin Nutr. 2010 Dec;92(6):1385-92. doi: 10.3945/ajcn.2010.30051. Epub 2010 Oct 6. Erratum In: Am J Clin Nutr. 2015 Apr;101(4):894.
PMID: 20926522
responsible party type: Principal Investigator
investigator affiliation: Swiss Federal Institute of Technology
investigator full name: Prof. Michael B. Zimmermann
investigator title: Professor, MD