<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/NCT03801486</url>
  </required_header>
  <id_info>
    <org_study_id>15-16-133</org_study_id>
    <nct_id>NCT03801486</nct_id>
  </id_info>
  <brief_title>Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation</brief_title>
  <official_title>The Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montclair State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montclair State University</source>
  <oversight_info>
    <has_dmc>No</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>
      The investigators examined the effects on post-digestion brachial artery flow mediated&#xD;
      dilation (FMD) and in vitro antioxidant capacity of 40% semolina flour replacement with&#xD;
      sprouted chickpea flour.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the current study was to examine in-vitro and in-vivo effects of replacing 40%&#xD;
      of semolina flour with sprouted chickpea flour for the use in pasta. Antioxidant capacity&#xD;
      in-vitro was measured by Trolox Equivalent Antioxidant Capacity. Brachial artery&#xD;
      flow-mediated dilation, a test of in-vivo endothelial function, was performed for assessment&#xD;
      of effects on post-digestion endothelial function. The investigators hypothesized that FMD&#xD;
      would be higher after consuming 40% of semolina flour with sprouted chickpea flour pasta vs.&#xD;
      100% of semolina flour pasta.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2016</start_date>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">May 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post-digestion flow mediated dilation</measure>
    <time_frame>Two hours following meal</time_frame>
    <description>Post meal</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>Experimental (SCF40)</arm_group_label>
    <description>At the experimental data collection visits participants consumed 255g of pasta made with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (SEM100)</arm_group_label>
    <description>At the control data collection visits participants consumed 255g of pasta made with 100% semolina flour (SEM100) with butter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental: Sprouted Chickpea Flour</intervention_name>
    <description>255g of pasta with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.</description>
    <arm_group_label>Experimental (SCF40)</arm_group_label>
    <other_name>SCF40</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control: Semolina Flour</intervention_name>
    <description>255g of pasta with 100% semolina flour (SEM100) with butter.</description>
    <arm_group_label>Control (SEM100)</arm_group_label>
    <other_name>SEM100</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adult&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have diabetes mellitus, kidney disease, a history of cancer, cardiac issues, pulmonary&#xD;
             disease, history of a stroke, obesity (for most people this means a body mass index&#xD;
             greater than 30), or any life threatening chronic conditions.&#xD;
&#xD;
          -  food allergies relevant to wheat, gluten, chickpea, and pasta sauce.&#xD;
&#xD;
          -  are currently being treated for infectious mononucleosis, hepatitis, pneumonia, or&#xD;
             other infectious diseases.&#xD;
&#xD;
          -  are unable or unwilling to refrain from recreational drug (marijuana, cocaine, etc.)&#xD;
             or alcohol use during the 24 hours prior to your exercise session.&#xD;
&#xD;
          -  use nicotine products, or non-contraceptive hormonal therapy (birth control is okay).&#xD;
&#xD;
          -  are pregnant or trying to become pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</mesh_term>
  </condition_browse>
  <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/NCT03801486
org study id: 15-16-133
nct id: NCT03801486
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators examined the effects on post-digestion brachial artery flow mediated
      dilation (FMD) and in vitro antioxidant capacity of 40% semolina flour replacement with
      sprouted chickpea flour.
The purpose of the current study was to examine in-vitro and in-vivo effects of replacing 40%
      of semolina flour with sprouted chickpea flour for the use in pasta. Antioxidant capacity
      in-vitro was measured by Trolox Equivalent Antioxidant Capacity. Brachial artery
      flow-mediated dilation, a test of in-vivo endothelial function, was performed for assessment
      of effects on post-digestion endothelial function. The investigators hypothesized that FMD
      would be higher after consuming 40% of semolina flour with sprouted chickpea flour pasta vs.
      100% of semolina flour pasta.
observational model: Case-Crossover
time perspective: Prospective
measure: Post-digestion flow mediated dilation
time frame: Two hours following meal
description: Post meal
arm group label: Experimental (SCF40)
description: At the experimental data collection visits participants consumed 255g of pasta made with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.
arm group label: Control (SEM100)
description: At the control data collection visits participants consumed 255g of pasta made with 100% semolina flour (SEM100) with butter.
intervention type: Other
intervention name: Experimental: Sprouted Chickpea Flour
description: 255g of pasta with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.
arm group label: Experimental (SCF40)
other name: SCF40
intervention type: Other
intervention name: Control: Semolina Flour
description: 255g of pasta with 100% semolina flour (SEM100) with butter.
arm group label: Control (SEM100)
other name: SEM100
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Dilatation, Pathologic
sharing ipd: No