<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/NCT02215278</url>
  </required_header>
  <id_info>
    <org_study_id>lpa_002</org_study_id>
    <nct_id>NCT02215278</nct_id>
  </id_info>
  <brief_title>A Multiple Meal Stable Iron Isotope Study in Iron Deficient Rwandese Women to Investigate the Performance of Low Phytic Acid Bean Seeds</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>GroundWork</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HarvestPlus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GroundWork</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent iron absorption studies with biofortified beans indicated that the currently developed&#xD;
      beans do not provide an extra amount of iron compared to normal iron beans. This effect was&#xD;
      ascribed to the inhibitory nature of phytic acid (PA), which is present in high&#xD;
      concentrations. A possible solution to alleviate problems associated with the high PA&#xD;
      concentration in beans might be low phytic acid (lpa) bean seeds. These beans, which exhibit&#xD;
      a good agronomic performance, were tested in a human absorption study in Switzerland and&#xD;
      provided a higher amount of bioavailable iron compared to their parent beans with normal PA&#xD;
      concentrations. However, the informative value of the study for the real life situation is&#xD;
      limited due to the simple study design with a relatively large amount of isotopic label added&#xD;
      extrinsically (≈30% of total iron). Furthermore, the study was conducted in iron sufficient&#xD;
      women in a non-bean consuming population. Additional investigations are necessary to verify&#xD;
      that iron bioavailability from lpa beans is high and that their performance is better&#xD;
      compared to common biofortified beans in a real life situation. A multiple meal randomized&#xD;
      crossover study in Rwandese women with low iron status will be done to measure iron&#xD;
      absorption from three different beans (lpa bean line, biofortified high iron bean, normal&#xD;
      iron bean as a control). During the study, the subjects will receive multiple meals to reduce&#xD;
      the amount of extrinsic label, therefore more closely simulating hypothetical dietary iron&#xD;
      intake from lpa beans. This will also allow to avoid an overestimation of the effect of&#xD;
      inhibitors and to minimize the influence of intra subject day to day variation. The study&#xD;
      will be divided into two parts. In part one, two of the three bean varieties will be fed as&#xD;
      part of composite meals over several days (morning and lunch) and in part two, the remaining&#xD;
      bean will be administered as part of composite meals over several days (morning and lunch).&#xD;
      Iron absorption from the three varieties will be measured and compared with erythrocyte&#xD;
      incorporation of stable isotopic labels 14 days after test meal administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Iron bioavailability from lpa bean variety compared to an iron biofortified variety</measure>
    <time_frame>2 month</time_frame>
    <description>Iron bioavailability is determined by measuring the amounts of isotopic labels in blood 14 d after administration of the test meals. It is calculated on the basis of the shift in iron isotope ratios and on the estimated amount of iron circulating in the body. Circulating iron is calculated based on the blood volume estimated from height and weight and measured Hb concentration. The calculations are based on the principles of isotope dilution. For calculation of fractional absorption, 80% incorporation of the absorbed Fe into red blood cells is assumed.&#xD;
Isotopic analysis are performed by negative thermal ionization mass spectrometry using a magnetic sector field mass spectrometer equipped with a multi-collector system for simultaneous ion beam detection</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Enrichment of Blood With Stable Iron Isotopes</condition>
  <arm_group>
    <arm_group_label>low phytic acid bean (lpa variety)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>high iron biofortified bean variety</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>normal iron, normal phytic acid bean</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>10 x 55 g/ bean per arm</intervention_name>
    <arm_group_label>high iron biofortified bean variety</arm_group_label>
    <arm_group_label>low phytic acid bean (lpa variety)</arm_group_label>
    <arm_group_label>normal iron, normal phytic acid bean</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non pregnant women, non lactating women&#xD;
&#xD;
          -  18-30 years&#xD;
&#xD;
          -  &lt;65 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metabolic, chronic or gastrointestinal disease&#xD;
&#xD;
          -  long term medication&#xD;
&#xD;
          -  blood donation within the last 6 month&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolai Petry, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GroundWork</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Diego Moretti, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ETH Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rwanda</name>
      <address>
        <city>Butare</city>
        <state>Huye</state>
        <country>Rwanda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Rwanda</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 15, 2018</last_update_submitted>
  <last_update_submitted_qc>August 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>GroundWork</investigator_affiliation>
    <investigator_full_name>Nicolai Petry</investigator_full_name>
    <investigator_title>Dr. of Science ETH</investigator_title>
  </responsible_party>
  <keyword>iron biofortification</keyword>
  <keyword>lpa bean</keyword>
  <keyword>stable iron isotope study</keyword>
  <keyword>phytic acid</keyword>
  <!-- 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/NCT02215278
org study id: lpa_002
nct id: NCT02215278
lead sponsor: 
collaborator: 
has dmc: No
Recent iron absorption studies with biofortified beans indicated that the currently developed
      beans do not provide an extra amount of iron compared to normal iron beans. This effect was
      ascribed to the inhibitory nature of phytic acid (PA), which is present in high
      concentrations. A possible solution to alleviate problems associated with the high PA
      concentration in beans might be low phytic acid (lpa) bean seeds. These beans, which exhibit
      a good agronomic performance, were tested in a human absorption study in Switzerland and
      provided a higher amount of bioavailable iron compared to their parent beans with normal PA
      concentrations. However, the informative value of the study for the real life situation is
      limited due to the simple study design with a relatively large amount of isotopic label added
      extrinsically (≈30% of total iron). Furthermore, the study was conducted in iron sufficient
      women in a non-bean consuming population. Additional investigations are necessary to verify
      that iron bioavailability from lpa beans is high and that their performance is better
      compared to common biofortified beans in a real life situation. A multiple meal randomized
      crossover study in Rwandese women with low iron status will be done to measure iron
      absorption from three different beans (lpa bean line, biofortified high iron bean, normal
      iron bean as a control). During the study, the subjects will receive multiple meals to reduce
      the amount of extrinsic label, therefore more closely simulating hypothetical dietary iron
      intake from lpa beans. This will also allow to avoid an overestimation of the effect of
      inhibitors and to minimize the influence of intra subject day to day variation. The study
      will be divided into two parts. In part one, two of the three bean varieties will be fed as
      part of composite meals over several days (morning and lunch) and in part two, the remaining
      bean will be administered as part of composite meals over several days (morning and lunch).
      Iron absorption from the three varieties will be measured and compared with erythrocyte
      incorporation of stable isotopic labels 14 days after test meal administration.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Iron bioavailability from lpa bean variety compared to an iron biofortified variety
time frame: 2 month
description: Iron bioavailability is determined by measuring the amounts of isotopic labels in blood 14 d after administration of the test meals. It is calculated on the basis of the shift in iron isotope ratios and on the estimated amount of iron circulating in the body. Circulating iron is calculated based on the blood volume estimated from height and weight and measured Hb concentration. The calculations are based on the principles of isotope dilution. For calculation of fractional absorption, 80% incorporation of the absorbed Fe into red blood cells is assumed.
Isotopic analysis are performed by negative thermal ionization mass spectrometry using a magnetic sector field mass spectrometer equipped with a multi-collector system for simultaneous ion beam detection
arm group label: low phytic acid bean (lpa variety)
arm group type: Experimental
arm group label: high iron biofortified bean variety
arm group type: Experimental
arm group label: normal iron, normal phytic acid bean
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: 10 x 55 g/ bean per arm
arm group label: high iron biofortified bean variety
arm group label: low phytic acid bean (lpa variety)
arm group label: normal iron, normal phytic acid bean
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicolai Petry, PhD
role: Principal Investigator
affiliation: GroundWork
last name: Diego Moretti, PhD
role: Principal Investigator
affiliation: ETH Zurich
facility: 
country: Rwanda
responsible party type: Principal Investigator
investigator affiliation: GroundWork
investigator full name: Nicolai Petry
investigator title: Dr. of Science ETH