<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/NCT03779971</url>
  </required_header>
  <id_info>
    <org_study_id>HS66-Lentil/Chickpea Study</org_study_id>
    <nct_id>NCT03779971</nct_id>
  </id_info>
  <brief_title>Energy Value of Lentils and Chickpeas</brief_title>
  <official_title>Energy Value of Lentils and Chickpeas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Beltsville Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Beltsville Human Nutrition Research Center</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>
      This study is being conducted to determine the digestibility of and available energy from&#xD;
      pulses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have demonstrated that the metabolizable energy (energy available to the&#xD;
      body) from tree nuts is less than predicted by the Atwater factors (the standard approach to&#xD;
      determining calorie value of a food). The Atwater approach is over 100 years old and is&#xD;
      inaccurate for some foods. This study will be conducted to determine the metabolizable energy&#xD;
      from two pulses, lentils and chickpeas. The study will be a human nutrition intervention&#xD;
      involving consumption of a controlled diet followed by collection of urine and feces.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2019</start_date>
  <completion_date type="Actual">March 23, 2020</completion_date>
  <primary_completion_date type="Actual">March 23, 2020</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>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Treatments will be color coded, and samples will be labeled only by subject number and date. Investigators and outcomes assessors will not know the treatments nor the color code until after the data analyses are complete.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Energy excreted in feces and urine</measure>
    <time_frame>Cumulative from day 10-17</time_frame>
    <description>Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy excreted in feces and urine</measure>
    <time_frame>Cumulative from day 39-46</time_frame>
    <description>Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy excreted in feces and urine</measure>
    <time_frame>Cumulative from day 57-64</time_frame>
    <description>Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nitrogen excreted in feces and urine</measure>
    <time_frame>Cumulative from day 10-17, day 39-46, day 57-64</time_frame>
    <description>Nitrogen (g) excreted in feces and urine will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat excreted in feces</measure>
    <time_frame>Cumulative from day 10-17, day 39-46, day 57-64</time_frame>
    <description>Fat (g) excreted in feces will be measured.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Adults</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo comparator will be a fully controlled diet made from typical American foods and containing no beans or pulses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lentil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The lentil arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain lentils.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chickpeas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The chickpea arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain chickpeas.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Diet</intervention_name>
    <description>Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lentil Containing Diet</intervention_name>
    <description>Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.</description>
    <arm_group_label>Lentil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chickpea Containing Diet</intervention_name>
    <description>Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.</description>
    <arm_group_label>Chickpeas</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 19 and 38 kg/m2&#xD;
&#xD;
          -  Age 25 to 75 years during intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known (self-reported) allergy or adverse reaction to study foods&#xD;
&#xD;
          -  Women who have given birth during the previous 12 months or who are pregnant/lactating&#xD;
             or who plan to become pregnant during the study&#xD;
&#xD;
          -  History of bariatric surgery or nutrient malabsorption disease (such as celiac&#xD;
             disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with&#xD;
             the study&#xD;
&#xD;
          -  History of certain cancer diagnosis or treatment in the last 3 years&#xD;
&#xD;
          -  Smoking or use of tobacco products in the past 6 months&#xD;
&#xD;
          -  Suspected or known strictures, fistulas or physiological/mechanical GI obstruction&#xD;
&#xD;
          -  Use of certain medications or supplements (prescription or over-the-counter) that may&#xD;
             interfere with the study objectives, including blood thinning medications&#xD;
&#xD;
          -  Unable or unwilling to give informed consent or communicate with study staff&#xD;
&#xD;
          -  Self-report of alcohol or substance abuse within the past 12 months and/or current&#xD;
             treatment for these problems (long-term participation in Alcoholics Anonymous is not&#xD;
             an exclusion)&#xD;
&#xD;
          -  Other medical, psychiatric, or behavioral factors that in the judgment of the&#xD;
             Principal Investigator may interfere with study participation or the ability to follow&#xD;
             the intervention protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Mirecki, MS</last_name>
    <role>Study Director</role>
    <affiliation>US Department of Agriculture</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA Beltsville Human Nutrition Research Center</name>
      <address>
        <city>Beltsville</city>
        <state>Maryland</state>
        <zip>20705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>USDA Beltsville Human Nutrition Research Center</investigator_affiliation>
    <investigator_full_name>Janet Novotny</investigator_full_name>
    <investigator_title>Research Physiologist</investigator_title>
  </responsible_party>
  <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/NCT03779971
org study id: HS66-Lentil/Chickpea Study
nct id: NCT03779971
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is being conducted to determine the digestibility of and available energy from
      pulses.
Previous studies have demonstrated that the metabolizable energy (energy available to the
      body) from tree nuts is less than predicted by the Atwater factors (the standard approach to
      determining calorie value of a food). The Atwater approach is over 100 years old and is
      inaccurate for some foods. This study will be conducted to determine the metabolizable energy
      from two pulses, lentils and chickpeas. The study will be a human nutrition intervention
      involving consumption of a controlled diet followed by collection of urine and feces.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
masking description: Treatments will be color coded, and samples will be labeled only by subject number and date. Investigators and outcomes assessors will not know the treatments nor the color code until after the data analyses are complete.
measure: Energy excreted in feces and urine
time frame: Cumulative from day 10-17
description: Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
measure: Energy excreted in feces and urine
time frame: Cumulative from day 39-46
description: Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
measure: Energy excreted in feces and urine
time frame: Cumulative from day 57-64
description: Energy (units of calories) excreted in feces and urine will be determined by bomb calorimetry.
measure: Nitrogen excreted in feces and urine
time frame: Cumulative from day 10-17, day 39-46, day 57-64
description: Nitrogen (g) excreted in feces and urine will be measured.
measure: Fat excreted in feces
time frame: Cumulative from day 10-17, day 39-46, day 57-64
description: Fat (g) excreted in feces will be measured.
arm group label: Control
arm group type: Placebo Comparator
description: The placebo comparator will be a fully controlled diet made from typical American foods and containing no beans or pulses.
arm group label: Lentil
arm group type: Experimental
description: The lentil arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain lentils.
arm group label: Chickpeas
arm group type: Experimental
description: The chickpea arm will consist of a fully controlled diet made from the same foods as the placebo arm and will also contain chickpeas.
intervention type: Other
intervention name: Control Diet
description: Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans.
arm group label: Control
intervention type: Other
intervention name: Lentil Containing Diet
description: Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.
arm group label: Lentil
intervention type: Other
intervention name: Chickpea Containing Diet
description: Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.
arm group label: Chickpeas
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roman Mirecki, MS
role: Study Director
affiliation: US Department of Agriculture
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: USDA Beltsville Human Nutrition Research Center
investigator full name: Janet Novotny
investigator title: Research Physiologist
sharing ipd: No