<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/NCT03041103</url>
  </required_header>
  <id_info>
    <org_study_id>985880</org_study_id>
    <nct_id>NCT03041103</nct_id>
  </id_info>
  <brief_title>Acceptability and Tolerance of a Protein and Micronutrient Fortified Food</brief_title>
  <official_title>Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      Acceptability and tolerance of a new food product in adults and children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and&#xD;
      10 (40 - 60 years of age), and in children (9-13 years of age). All participants will be&#xD;
      asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while&#xD;
      the children will be asked to consume the same product every day for one week. The&#xD;
      participants will record amount of daily intake, and will be given an entry and exit surveys.&#xD;
      These surveys will include the assessment of potential gastrointestinal changes with daily&#xD;
      product intake, and will include questions on how they liked the product. Acceptability will&#xD;
      be measured as the number of servings and portion of serving completed each day over the&#xD;
      trial period.&#xD;
&#xD;
      In adults only, fasting blood samples and a spot urine will be collected towards preliminary&#xD;
      work on potential changes in the metabolome and lipidome with the inclusion of the test&#xD;
      product within the habitual diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single arm not blind</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GI function</measure>
    <time_frame>at 2 weeks</time_frame>
    <description>GI function questionnaire with categorical numerical score</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Poor Nutrition</condition>
  <arm_group>
    <arm_group_label>Adult</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food Product 1</intervention_name>
    <description>50 grams of fortified nutritious product from legumes</description>
    <arm_group_label>Adult</arm_group_label>
    <arm_group_label>Children</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        ° Inclusion Criteria:&#xD;
&#xD;
          -  Male, 40-60 years old&#xD;
&#xD;
          -  Male or Female 9-13 years old&#xD;
&#xD;
          -  Subject is willing and able to comply with the study protocols&#xD;
&#xD;
          -  Subject is willing to consume the test products&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten&#xD;
&#xD;
          -  Under current medical supervision&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Self-reported history of cardiovascular disease, stroke, cancer, renal, hepatic, or&#xD;
             thyroid disease, GI tract disorders, previous GI surgery&#xD;
&#xD;
          -  Currently taking prescription drugs or supplements&#xD;
&#xD;
          -  Daily use of aspirin and or non-steroidal anti-inflammatory medicines.&#xD;
&#xD;
          -  Indications of substance or alcohol abuse within the last 3 years&#xD;
&#xD;
          -  Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish&#xD;
             oil, and oil supplements.&#xD;
&#xD;
          -  Self-reported malabsorption&#xD;
&#xD;
          -  Current enrollee in a clinical research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl L Keen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</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>Malnutrition</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/NCT03041103
org study id: 985880
nct id: NCT03041103
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acceptability and tolerance of a new food product in adults and children.
Acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and
      10 (40 - 60 years of age), and in children (9-13 years of age). All participants will be
      asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while
      the children will be asked to consume the same product every day for one week. The
      participants will record amount of daily intake, and will be given an entry and exit surveys.
      These surveys will include the assessment of potential gastrointestinal changes with daily
      product intake, and will include questions on how they liked the product. Acceptability will
      be measured as the number of servings and portion of serving completed each day over the
      trial period.

      In adults only, fasting blood samples and a spot urine will be collected towards preliminary
      work on potential changes in the metabolome and lipidome with the inclusion of the test
      product within the habitual diet.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Single arm not blind
primary purpose: Other
masking: None (Open Label)
measure: GI function
time frame: at 2 weeks
description: GI function questionnaire with categorical numerical score
arm group label: Adult
arm group type: Experimental
description: Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks
arm group label: Children
arm group type: Experimental
description: Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks
intervention type: Other
intervention name: Food Product 1
description: 50 grams of fortified nutritious product from legumes
arm group label: Adult
arm group label: Children
criteria: 
gender: All
minimum age: 9 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carl L Keen, PhD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No