<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/NCT03019393</url>
  </required_header>
  <id_info>
    <org_study_id>13-441</org_study_id>
    <nct_id>NCT03019393</nct_id>
  </id_info>
  <brief_title>Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)</brief_title>
  <official_title>Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Walczyk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University of Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin&#xD;
      bound iron (NTBI)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During Visit 1, blood samples will be collected to assess iron status. During Visit 2, after&#xD;
      an overnight fast, participant will be given a standardized meal (rice and potatoes) with a&#xD;
      portion of cooked beef (200 g). Blood samples will be collected right before and 2 hour after&#xD;
      the meal for NTBI analysis.&#xD;
&#xD;
      NTBI concentration before and after meal consumption will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of serum non-transferrin bound iron (NTBI) after consumption of red meat</measure>
    <time_frame>2 hour post meal administration</time_frame>
    <description>Blood samples collected 2 h after consumption of red meat will be analyzed for non-transferrin bound iron (NTBI) concentration</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Beef</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Beef topside fully cooked, 200g</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Beef</intervention_name>
    <description>200 g beef topside which is fully cooked will be provided to participant after overnight fast. The intervention is one time only.</description>
    <arm_group_label>Beef</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy male volunteers (21 - 45 years old)&#xD;
&#xD;
          -  C-reactive protein (CRP) &lt; 5 mg/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood donation or significant blood loss (e.g. surgery) within the past 4 months&#xD;
&#xD;
          -  Regular intake of iron and other nutrient supplements within the past 4 months&#xD;
&#xD;
          -  Regular intake of medication except oral contraceptives&#xD;
&#xD;
          -  Acute or recent inflammatory or infectious symptoms&#xD;
&#xD;
          -  Chronic gastrointestinal disorders or metabolic diseases&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Coeliac disease or gluten-related disorders&#xD;
&#xD;
          -  Iron deficiency anemia (Hb &lt; 14 g/dL for males) with serum ferritin concentration &lt; 30&#xD;
             ng/mL)&#xD;
&#xD;
          -  Non-iron deficiency anemia (serum ferritin concentration within normal range (30 - 300&#xD;
             ng/mL for males) but low hemoglobin (&lt; 14 g/dL for males)&#xD;
&#xD;
          -  Iron overload conditions (serum ferritin concentration &gt; 300 ng/mL for males)&#xD;
&#xD;
          -  Known hereditary disorders of iron metabolism&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Walczyk, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National University of Singapore; National University Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Trumbo P, Yates AA, Schlicker S, Poos M. Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 2001 Mar;101(3):294-301. doi: 10.1016/S0002-8223(01)00078-5. No abstract available.</citation>
    <PMID>11269606</PMID>
  </reference>
  <reference>
    <citation>Monsen ER, Hallberg L, Layrisse M, Hegsted DM, Cook JD, Mertz W, Finch CA. Estimation of available dietary iron. Am J Clin Nutr. 1978 Jan;31(1):134-41. doi: 10.1093/ajcn/31.1.134.</citation>
    <PMID>619599</PMID>
  </reference>
  <reference>
    <citation>Papanikolaou G, Pantopoulos K. Iron metabolism and toxicity. Toxicol Appl Pharmacol. 2005 Jan 15;202(2):199-211. doi: 10.1016/j.taap.2004.06.021.</citation>
    <PMID>15629195</PMID>
  </reference>
  <reference>
    <citation>Hutchinson C, Al-Ashgar W, Liu DY, Hider RC, Powell JJ, Geissler CA. Oral ferrous sulphate leads to a marked increase in pro-oxidant nontransferrin-bound iron. Eur J Clin Invest. 2004 Nov;34(11):782-4. doi: 10.1111/j.1365-2362.2004.01416.x. No abstract available.</citation>
    <PMID>15530152</PMID>
  </reference>
  <reference>
    <citation>Schumann K, Kroll S, Romero-Abal ME, Georgiou NA, Marx JJ, Weiss G, Solomons NW. Impact of oral iron challenges on circulating non-transferrin-bound iron in healthy Guatemalan males. Ann Nutr Metab. 2012;60(2):98-107. doi: 10.1159/000336177. Epub 2012 Mar 6.</citation>
    <PMID>22398912</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National University of Singapore</investigator_affiliation>
    <investigator_full_name>Thomas Walczyk</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>non-transferrin bound iron (NTBI)</keyword>
  <keyword>Red meat</keyword>
  <keyword>Non-transferrin bound iron (NTBI) in serum</keyword>
  <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/NCT03019393
org study id: 13-441
nct id: NCT03019393
lead sponsor: 
has dmc: No
This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin
      bound iron (NTBI)
During Visit 1, blood samples will be collected to assess iron status. During Visit 2, after
      an overnight fast, participant will be given a standardized meal (rice and potatoes) with a
      portion of cooked beef (200 g). Blood samples will be collected right before and 2 hour after
      the meal for NTBI analysis.

      NTBI concentration before and after meal consumption will be compared.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Occurrence of serum non-transferrin bound iron (NTBI) after consumption of red meat
time frame: 2 hour post meal administration
description: Blood samples collected 2 h after consumption of red meat will be analyzed for non-transferrin bound iron (NTBI) concentration
arm group label: Beef
arm group type: Other
description: Beef topside fully cooked, 200g
intervention type: Other
intervention name: Beef
description: 200 g beef topside which is fully cooked will be provided to participant after overnight fast. The intervention is one time only.
arm group label: Beef
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Walczyk, Ph.D
role: Principal Investigator
affiliation: National University of Singapore
facility: 
country: Singapore
citation: Trumbo P, Yates AA, Schlicker S, Poos M. Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 2001 Mar;101(3):294-301. doi: 10.1016/S0002-8223(01)00078-5. No abstract available.
PMID: 11269606
citation: Monsen ER, Hallberg L, Layrisse M, Hegsted DM, Cook JD, Mertz W, Finch CA. Estimation of available dietary iron. Am J Clin Nutr. 1978 Jan;31(1):134-41. doi: 10.1093/ajcn/31.1.134.
PMID: 619599
citation: Papanikolaou G, Pantopoulos K. Iron metabolism and toxicity. Toxicol Appl Pharmacol. 2005 Jan 15;202(2):199-211. doi: 10.1016/j.taap.2004.06.021.
PMID: 15629195
citation: Hutchinson C, Al-Ashgar W, Liu DY, Hider RC, Powell JJ, Geissler CA. Oral ferrous sulphate leads to a marked increase in pro-oxidant nontransferrin-bound iron. Eur J Clin Invest. 2004 Nov;34(11):782-4. doi: 10.1111/j.1365-2362.2004.01416.x. No abstract available.
PMID: 15530152
citation: Schumann K, Kroll S, Romero-Abal ME, Georgiou NA, Marx JJ, Weiss G, Solomons NW. Impact of oral iron challenges on circulating non-transferrin-bound iron in healthy Guatemalan males. Ann Nutr Metab. 2012;60(2):98-107. doi: 10.1159/000336177. Epub 2012 Mar 6.
PMID: 22398912
responsible party type: Sponsor-Investigator
investigator affiliation: National University of Singapore
investigator full name: Thomas Walczyk
investigator title: Associate Professor
sharing ipd: No