xml: <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/NCT06032832</url>
    </required_header>
    <id_info>
      <org_study_id>Iron_LINDA_2023</org_study_id>
      <nct_id>NCT06032832</nct_id>
    </id_info>
    <brief_title>Iron Absorption From Naturally Dephytinized Legumes</brief_title>
    <acronym>LINDA</acronym>
    <official_title>The Effect of Dephytinization on Iron Absorption From a Soy Protein Based Meat Analog and Chickpea-farinata: a Randomized Study in Young Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Diego Moretti</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Swiss Distance University of Applied Sciences</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Consumption of less meat and more plant-based protein can greatly reduce the negative impact&#xD;
        of food production on the environment. Studies show that vegan diets can decrease greenhouse&#xD;
        gas emissions, land use, and water. However, it is important to consider the nutritional&#xD;
        value of alternatives, as meat is a key source of nutrients like iron. Iron deficiency anemia&#xD;
        (IDA) is estimated to be the top 5 leading causes of years lived with disability burden&#xD;
        globally and the first cause in women. Nutritional iron deficiency anemia is often caused by&#xD;
        low iron content and low dietary iron bioavailability. As meat, fish, and poultry are&#xD;
        excellent sources of bioavailable iron, shifting or maintaining a predominantly plant-based&#xD;
        diet can increase the risk of iron deficiency (ID).&#xD;
  &#xD;
        Phytic acid, the main phosphorus storage compound in plants, can hinder iron absorption and&#xD;
        other divalent minerals. Phytase is an enzyme that breaks down phytic acid, which lessens its&#xD;
        ability to bind with minerals like iron. This enzyme is present in various plant tissues,&#xD;
        with particularly high amounts found in wheat and rye.&#xD;
  &#xD;
        There is limited clinical evidence regarding iron absorption from plant-based meat. Thus, it&#xD;
        is important to measure iron absorption from plant-based foods before and after treatment to&#xD;
        remove phytic acid (dephytinization). This study compares the fractional iron absorption&#xD;
        (FIA) of the 1) soy protein concentrate meat analog and 2) Farinata made from chickpea flour,&#xD;
        both with and without dephytinization.&#xD;
  &#xD;
        The aim of this study is to determine the effect of phytic acid reduction on iron absorption.&#xD;
        FIA of the soy protein concentrates meat analog with phytic acid will be compared with FIA&#xD;
        from soy protein concentrate without dephytinization. In addition, this study will compare&#xD;
        the FIA in Farinata, a traditional Italian dish prepared using chickpea flour, both with and&#xD;
        without dephytinization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this clinical trial is to assess the iron absorption from plant-based protein&#xD;
        with and without the reduction of phytic acid. This study is a randomized control trial,&#xD;
        cross-over where each participant acts as their own control.&#xD;
  &#xD;
        Participants will be asked to consume test meals prepared from soy protein and chickpea flour&#xD;
        with and without dephytinization that contains isotopic iron (57Fe and 58Fe) as ferrous&#xD;
        sulfate. After 14 days of the test meal administration, participants will be given blood&#xD;
        samples to access the isotopic iron enrichment in blood.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>
      <intervention_model_description>Randomized control trial, cross-over</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Test meals will be randomized and served to participants. Participants will not know or taste the differences of dephytinization in soy protein concentrate or in chickpea.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Fractional iron absorption</measure>
      <time_frame>Baseline, 14 day after test meal administration</time_frame>
      <description>The fraction of absorbed iron from isotropic iron contain in the testmeal. This fractional iron absorption will be measure from blood sample after 14 day of test meal administration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Iron status</measure>
      <time_frame>Baseline, 14 day after test meal administration</time_frame>
      <description>Hemoglobin (Hb), plasma ferritin (PF), and serum soluble transferrin receptor (sTfR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inflammatory status</measure>
      <time_frame>Baseline, 14 day after test meal administration</time_frame>
      <description>Alpha-1-acid glycoprotein (AGP), C-reactive protein (CRP)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Iron Deficiencies</condition>
    <arm_group>
      <arm_group_label>Soy protein concentrate meat analog</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Meat analog made from soy protein concentrate contains 57Fe as ferrous sulfate. All participants will consume this test meal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Soy protein concentrate meat analog without phytic acid</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Meat analog made from soy protein concentrate that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Farinata_chickpea flour</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Farinata (thin pancake) made from chickpea flour contains 57Fe as ferrous sulfate. All participants will consume this test meal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Farinata_chickpea flour without phytic acid</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Farinata (thin pancake) made from chickpea flour that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>soy protein concentrate-meat analog</intervention_name>
      <description>Baked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate</description>
      <arm_group_label>Soy protein concentrate meat analog</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>soy protein concentrate-meat analog_dephytinization</intervention_name>
      <description>Baked dephytinized_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate</description>
      <arm_group_label>Soy protein concentrate meat analog without phytic acid</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Farinata</intervention_name>
      <description>Pancake made from chickpea flour contains 57Fe as ferrous sulfate</description>
      <arm_group_label>Farinata_chickpea flour</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Farinata_dephytinization</intervention_name>
      <description>Pancake made from dephytinized chickpea flour contains 58Fe as ferrous sulfate.</description>
      <arm_group_label>Farinata_chickpea flour without phytic acid</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female aged between 18-45 y old&#xD;
  &#xD;
            -  Plasma ferritin &lt; 30 microgram/L&#xD;
  &#xD;
            -  BMI 18.5-25.0&#xD;
  &#xD;
            -  Weight &lt; 65 kg&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Anemic (Hb &lt; 12 g/dL)&#xD;
  &#xD;
            -  Inflammation (CRP &gt; 5 mg/L)&#xD;
  &#xD;
            -  Chronic digestive, renal and/or metabolic disease&#xD;
  &#xD;
            -  Chronic medications (except for oral contraceptives)&#xD;
  &#xD;
            -  Use of vitamin, mineral, and pre-and/or probiotic supplements in the previous 2 weeks&#xD;
               and during the study&#xD;
  &#xD;
            -  Blood transfusion, blood donation, or significant blood loss (&gt; 400 ml) over the past&#xD;
               4 months&#xD;
  &#xD;
            -  Difficulty with blood withdrawal&#xD;
  &#xD;
            -  Antibiotic treatment in the 4 weeks preceding the start of the study and during the&#xD;
               study&#xD;
  &#xD;
            -  Pregnancy (tested in serum at screening) or intention to become pregnant during the&#xD;
               course of the study&#xD;
  &#xD;
            -  Lactation&#xD;
  &#xD;
            -  Earlier participation in a study using stable isotopes or participation in any&#xD;
               clinical study within the last 30 days&#xD;
  &#xD;
            -  Participants who cannot be expected to comply with the study protocol (e.g. not&#xD;
               available on certain study appointments)&#xD;
  &#xD;
            -  Inability to understand the information sheet and the informed consent form due to&#xD;
               cognitive or language reasons&#xD;
  &#xD;
            -  Smoking&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Women are vulnerable to developing iron deficiency. Thus, this study aims to study in female population according to sex.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Diego Moretti, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>FFHS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pornpimol Scheuchzer, Ph.D</last_name>
      <phone>+41 44 512 09 75</phone>
      <email>pornpimol.scheuchzer@ffhs.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Diego Moretti, Ph.D</last_name>
      <phone>+41445120920</phone>
      <email>diego.moretti@ffhs.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fernfachhochschule Schweiz (FFHS) - Campus Gleisarena</name>
        <address>
          <city>Zürich</city>
          <zip>8005</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Diego Moretti, Ph.D</last_name>
        <phone>+41445120920</phone>
        <email>diego.moretti@ffhs.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Swiss Distance University of Applied Sciences</investigator_affiliation>
      <investigator_full_name>Diego Moretti</investigator_full_name>
      <investigator_title>Prof.Dr. Diego Moretti</investigator_title>
    </responsible_party>
    <keyword>plant based meat alternative</keyword>
    <keyword>iron absorption</keyword>
    <keyword>soy protein</keyword>
    <keyword>phytic acid</keyword>
    <keyword>dephytinization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Iron Deficiencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032832
  org study id: Iron_LINDA_2023
  nct id: NCT06032832
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Consumption of less meat and more plant-based protein can greatly reduce the negative impact
        of food production on the environment. Studies show that vegan diets can decrease greenhouse
        gas emissions, land use, and water. However, it is important to consider the nutritional
        value of alternatives, as meat is a key source of nutrients like iron. Iron deficiency anemia
        (IDA) is estimated to be the top 5 leading causes of years lived with disability burden
        globally and the first cause in women. Nutritional iron deficiency anemia is often caused by
        low iron content and low dietary iron bioavailability. As meat, fish, and poultry are
        excellent sources of bioavailable iron, shifting or maintaining a predominantly plant-based
        diet can increase the risk of iron deficiency (ID).
  
        Phytic acid, the main phosphorus storage compound in plants, can hinder iron absorption and
        other divalent minerals. Phytase is an enzyme that breaks down phytic acid, which lessens its
        ability to bind with minerals like iron. This enzyme is present in various plant tissues,
        with particularly high amounts found in wheat and rye.
  
        There is limited clinical evidence regarding iron absorption from plant-based meat. Thus, it
        is important to measure iron absorption from plant-based foods before and after treatment to
        remove phytic acid (dephytinization). This study compares the fractional iron absorption
        (FIA) of the 1) soy protein concentrate meat analog and 2) Farinata made from chickpea flour,
        both with and without dephytinization.
  
        The aim of this study is to determine the effect of phytic acid reduction on iron absorption.
        FIA of the soy protein concentrates meat analog with phytic acid will be compared with FIA
        from soy protein concentrate without dephytinization. In addition, this study will compare
        the FIA in Farinata, a traditional Italian dish prepared using chickpea flour, both with and
        without dephytinization.
  The goal of this clinical trial is to assess the iron absorption from plant-based protein
        with and without the reduction of phytic acid. This study is a randomized control trial,
        cross-over where each participant acts as their own control.
  
        Participants will be asked to consume test meals prepared from soy protein and chickpea flour
        with and without dephytinization that contains isotopic iron (57Fe and 58Fe) as ferrous
        sulfate. After 14 days of the test meal administration, participants will be given blood
        samples to access the isotopic iron enrichment in blood.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomized control trial, cross-over
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: Test meals will be randomized and served to participants. Participants will not know or taste the differences of dephytinization in soy protein concentrate or in chickpea.
  measure: Fractional iron absorption
  time frame: Baseline, 14 day after test meal administration
  description: The fraction of absorbed iron from isotropic iron contain in the testmeal. This fractional iron absorption will be measure from blood sample after 14 day of test meal administration
  measure: Iron status
  time frame: Baseline, 14 day after test meal administration
  description: Hemoglobin (Hb), plasma ferritin (PF), and serum soluble transferrin receptor (sTfR)
  measure: Inflammatory status
  time frame: Baseline, 14 day after test meal administration
  description: Alpha-1-acid glycoprotein (AGP), C-reactive protein (CRP)
  arm group label: Soy protein concentrate meat analog
  arm group type: Experimental
  description: Meat analog made from soy protein concentrate contains 57Fe as ferrous sulfate. All participants will consume this test meal.
  arm group label: Soy protein concentrate meat analog without phytic acid
  arm group type: Experimental
  description: Meat analog made from soy protein concentrate that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal.
  arm group label: Farinata_chickpea flour
  arm group type: Experimental
  description: Farinata (thin pancake) made from chickpea flour contains 57Fe as ferrous sulfate. All participants will consume this test meal.
  arm group label: Farinata_chickpea flour without phytic acid
  arm group type: Experimental
  description: Farinata (thin pancake) made from chickpea flour that was removed phytic acid (dephytinization) contains 58Fe as ferrous sulfate. All participants will consume this test meal.
  intervention type: Other
  intervention name: soy protein concentrate-meat analog
  description: Baked Meat analogs-soy protein concentrate containing 57Fe as ferrous sulfate
  arm group label: Soy protein concentrate meat analog
  intervention type: Other
  intervention name: soy protein concentrate-meat analog_dephytinization
  description: Baked dephytinized_Meat analogs-soy protein concentrate containing 58Fe as ferrous sulfate
  arm group label: Soy protein concentrate meat analog without phytic acid
  intervention type: Other
  intervention name: Farinata
  description: Pancake made from chickpea flour contains 57Fe as ferrous sulfate
  arm group label: Farinata_chickpea flour
  intervention type: Other
  intervention name: Farinata_dephytinization
  description: Pancake made from dephytinized chickpea flour contains 58Fe as ferrous sulfate.
  arm group label: Farinata_chickpea flour without phytic acid
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Women are vulnerable to developing iron deficiency. Thus, this study aims to study in female population according to sex.
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Diego Moretti, Ph.D
  role: Principal Investigator
  affiliation: FFHS
  last name: Pornpimol Scheuchzer, Ph.D
  phone: +41 44 512 09 75
  email: pornpimol.scheuchzer@ffhs.ch
  last name: Diego Moretti, Ph.D
  phone: +41445120920
  email: diego.moretti@ffhs.ch
  facility: 
  contact: 
  country: Switzerland
  responsible party type: Sponsor-Investigator
  investigator affiliation: Swiss Distance University of Applied Sciences
  investigator full name: Diego Moretti
  investigator title: Prof.Dr. Diego Moretti
  mesh term: Iron Deficiencies
  sharing ipd: No