<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/NCT02208622</url>
  </required_header>
  <id_info>
    <org_study_id>13-0398</org_study_id>
    <nct_id>NCT02208622</nct_id>
  </id_info>
  <brief_title>Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet</brief_title>
  <official_title>Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Autonoma de Queretaro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Atomic Energy Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bioavailability of iron and zinc from habitual plant-based diets consumed by young children&#xD;
      in Mexico is low due to the high phytate content. Whey protein has been found to increase&#xD;
      zinc absorption, thus, providing a whey based supplement with micronutrients may be an&#xD;
      effective strategy to increase iron and zinc bioavailability from plant-based foods and&#xD;
      alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron&#xD;
      in children receiving diets with and without whey protein supplements (WPS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study 1: Zinc absorption studies The zinc study employed a 2-day cross-over design, labeling&#xD;
      the WPS diet with a different zinc stable isotope (67Zn) than the control diet (70Zn). All&#xD;
      meals during the 2-day period were labeled with tracer. The dual isotope ratio technique was&#xD;
      used with a 3rd Zn stable isotope (68Zn) given intravenously and urine enrichment of all&#xD;
      isotopes measured on Study Days 6-9 to measure fractional absorption of Zn (FAZ). The amount&#xD;
      of Zn absorbed for the day was determined by multiplying the Zn intake for the day&#xD;
      (determined from lab analyses of duplicate test meals) by the FAZ. Children (n=16) were&#xD;
      randomized as to the order in which they consume the test and control meals on Study Day 1&#xD;
      and 2.&#xD;
&#xD;
      Study 2: Iron absorption studies The iron study was a cross sectional study with one group&#xD;
      receiving control meals and the second group receiving the same control meal plus WPS. Iron&#xD;
      absorption was measured using the erythrocyte iron incorporation technique with labeling of&#xD;
      all meals over 2 days (58Fe). This was preceded by a reference dose of Fe57 and ascorbate on&#xD;
      the previous day. Children (n=32) were randomized to receive the control diet or intervention&#xD;
      diet (control diet + WPS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Zinc Absorption</measure>
    <time_frame>2 days</time_frame>
    <description>Absorption of zinc was compared in young children when given a habitual diet with and without a whey protein supplement. Fractional absorption of zinc for a day was measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc was measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron Absorption</measure>
    <time_frame>2 days</time_frame>
    <description>Absorption of iron was compared in young children when given a habitual diet with and without a whey protein supplement. Fractional absorption of iron for two days was measured by extrinsic labeling with stable isotopes of iron and measuring erythrocyte enrichment. Measurement of total iron in duplicate diets on test days will allow determination of quantity of this micronutrient absorbed (mg/d).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Nutritional Deficiency</condition>
  <arm_group>
    <arm_group_label>Study 1: Whey Supplement Day 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in this arm received the whey supplement as part if their diet on day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study 1: Whey Supplement Day 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in this arm received whey supplement as part of their diet on day 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study 2: Whey Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in this arm received a whey supplement as part of their diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study 2: Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Children in this arm did not receive a whey supplement as part of their diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Study 1: Whey Supplement Day 1</intervention_name>
    <description>Whey supplement was given on day 1, control diet on day 2</description>
    <arm_group_label>Study 1: Whey Supplement Day 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Study 1: Whey Supplement Day 2</intervention_name>
    <description>Control diet was given day 1, whey supplement was given day 2</description>
    <arm_group_label>Study 1: Whey Supplement Day 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Study 2: Whey Supplement</intervention_name>
    <description>Whey supplement was given as part of diet for both day 1 and 2 of study</description>
    <arm_group_label>Study 2: Whey Supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2-3 years of age&#xD;
&#xD;
          -  Live in poor, rural communities&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Parents had provided informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An acute or chronic illness which affects gut function, or&#xD;
&#xD;
          -  They are breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Hambidge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Autonoma de Queretaro</name>
      <address>
        <city>Queretaro</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Zinc absorption</keyword>
  <keyword>Iron Absorption</keyword>
  <keyword>Whey Protein</keyword>
  <keyword>Mexico</keyword>
  <keyword>Stable isotopes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT02208622
org study id: 13-0398
nct id: NCT02208622
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Bioavailability of iron and zinc from habitual plant-based diets consumed by young children
      in Mexico is low due to the high phytate content. Whey protein has been found to increase
      zinc absorption, thus, providing a whey based supplement with micronutrients may be an
      effective strategy to increase iron and zinc bioavailability from plant-based foods and
      alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron
      in children receiving diets with and without whey protein supplements (WPS).
Study 1: Zinc absorption studies The zinc study employed a 2-day cross-over design, labeling
      the WPS diet with a different zinc stable isotope (67Zn) than the control diet (70Zn). All
      meals during the 2-day period were labeled with tracer. The dual isotope ratio technique was
      used with a 3rd Zn stable isotope (68Zn) given intravenously and urine enrichment of all
      isotopes measured on Study Days 6-9 to measure fractional absorption of Zn (FAZ). The amount
      of Zn absorbed for the day was determined by multiplying the Zn intake for the day
      (determined from lab analyses of duplicate test meals) by the FAZ. Children (n=16) were
      randomized as to the order in which they consume the test and control meals on Study Day 1
      and 2.

      Study 2: Iron absorption studies The iron study was a cross sectional study with one group
      receiving control meals and the second group receiving the same control meal plus WPS. Iron
      absorption was measured using the erythrocyte iron incorporation technique with labeling of
      all meals over 2 days (58Fe). This was preceded by a reference dose of Fe57 and ascorbate on
      the previous day. Children (n=32) were randomized to receive the control diet or intervention
      diet (control diet + WPS).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Zinc Absorption
time frame: 2 days
description: Absorption of zinc was compared in young children when given a habitual diet with and without a whey protein supplement. Fractional absorption of zinc for a day was measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc was measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).
measure: Iron Absorption
time frame: 2 days
description: Absorption of iron was compared in young children when given a habitual diet with and without a whey protein supplement. Fractional absorption of iron for two days was measured by extrinsic labeling with stable isotopes of iron and measuring erythrocyte enrichment. Measurement of total iron in duplicate diets on test days will allow determination of quantity of this micronutrient absorbed (mg/d).
arm group label: Study 1: Whey Supplement Day 1
arm group type: Experimental
description: Children in this arm received the whey supplement as part if their diet on day 1.
arm group label: Study 1: Whey Supplement Day 2
arm group type: Experimental
description: Children in this arm received whey supplement as part of their diet on day 2.
arm group label: Study 2: Whey Supplement
arm group type: Experimental
description: Children in this arm received a whey supplement as part of their diet.
arm group label: Study 2: Control
arm group type: No Intervention
description: Children in this arm did not receive a whey supplement as part of their diet.
intervention type: Dietary Supplement
intervention name: Study 1: Whey Supplement Day 1
description: Whey supplement was given on day 1, control diet on day 2
arm group label: Study 1: Whey Supplement Day 1
intervention type: Dietary Supplement
intervention name: Study 1: Whey Supplement Day 2
description: Control diet was given day 1, whey supplement was given day 2
arm group label: Study 1: Whey Supplement Day 2
intervention type: Dietary Supplement
intervention name: Study 2: Whey Supplement
description: Whey supplement was given as part of diet for both day 1 and 2 of study
arm group label: Study 2: Whey Supplement
criteria: 
gender: All
minimum age: 2 Years
maximum age: 3 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Hambidge, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
country: Mexico
country: United States
responsible party type: Sponsor
mesh term: Malnutrition