<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/NCT03783637</url>
  </required_header>
  <id_info>
    <org_study_id>HS62 - Single Grain</org_study_id>
    <nct_id>NCT03783637</nct_id>
  </id_info>
  <brief_title>Measuring Single-Serving Grain Intake</brief_title>
  <official_title>Measuring Single-Serving Grain Intake</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>
      The primary objective of this study is to identify markers of a single meal of whole grain&#xD;
      oat and whole grain wheat intake in humans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to identify compounds that are found in blood and urine and are&#xD;
      derived from a single meal of whole grain oat or whole grain wheat intake so that&#xD;
      epidemiological studies can be conducted to provide more accurate associations between whole&#xD;
      grain intake and health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2019</start_date>
  <completion_date type="Actual">June 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 19, 2019</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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of unknown biomarkers of grain intake immediately after grain consumption</measure>
    <time_frame>Day 8</time_frame>
    <description>Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of unknown biomarkers of grain intake a day after grain consumption</measure>
    <time_frame>Day 9</time_frame>
    <description>Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of unknown biomarkers of grain intake 2 days after grain consumption</measure>
    <time_frame>Day 10</time_frame>
    <description>Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of unknown biomarkers of grain intake immediately after grain consumption</measure>
    <time_frame>Day 34</time_frame>
    <description>Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of unknown biomarkers of grain intake a day after grain consumption</measure>
    <time_frame>Day 35</time_frame>
    <description>Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of unknown biomarkers of grain intake 2 days after grain consumption</measure>
    <time_frame>Day 36</time_frame>
    <description>Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>Days 8 and 34</time_frame>
    <description>Blood glucose will be measured. Blood glucose is reported in mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum insulin</measure>
    <time_frame>Days 8 and 34</time_frame>
    <description>Serum insulin will be measured. Serum insulin is reported in mIU/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum c-peptide</measure>
    <time_frame>Days 8 and 34</time_frame>
    <description>Serum c-peptide will be measured. Serum c-peptide is reported in ng/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-esterified fatty acids in blood</measure>
    <time_frame>Days 8 and 34</time_frame>
    <description>Non-esterified fatty acids will be measured in blood. Non-esterified fatty acids are reported as mEQ/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides in blood</measure>
    <time_frame>Days 8 and 34</time_frame>
    <description>Triglycerides will be measured. Triglycerides are reported as mmol/L.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Whole Grain Oat</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Volunteers will consume a breakfast meal containing whole grain oats after 7 days of a whole grain free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole Grain Wheat</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Volunteers will consume a breakfast meal containing whole grain wheat after 7 days of a whole grain free diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole grain oats</intervention_name>
    <description>A meal containing whole grain oats</description>
    <arm_group_label>Whole Grain Oat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole grain wheat</intervention_name>
    <description>A meal containing whole grain wheat</description>
    <arm_group_label>Whole Grain Wheat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  21 to 75 years of age&#xD;
&#xD;
          -  Voluntarily agree to participate and sign an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body weight less than 110 lbs.&#xD;
&#xD;
          -  Have a body mass index below 19 or above 38 kg/m2&#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>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>USDA-ARS 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>July 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</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/NCT03783637
org study id: HS62 - Single Grain
nct id: NCT03783637
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to identify markers of a single meal of whole grain
      oat and whole grain wheat intake in humans.
The aim of this study is to identify compounds that are found in blood and urine and are
      derived from a single meal of whole grain oat or whole grain wheat intake so that
      epidemiological studies can be conducted to provide more accurate associations between whole
      grain intake and health.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Identification of unknown biomarkers of grain intake immediately after grain consumption
time frame: Day 8
description: Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
measure: Identification of unknown biomarkers of grain intake a day after grain consumption
time frame: Day 9
description: Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
measure: Identification of unknown biomarkers of grain intake 2 days after grain consumption
time frame: Day 10
description: Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
measure: Identification of unknown biomarkers of grain intake immediately after grain consumption
time frame: Day 34
description: Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
measure: Identification of unknown biomarkers of grain intake a day after grain consumption
time frame: Day 35
description: Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
measure: Identification of unknown biomarkers of grain intake 2 days after grain consumption
time frame: Day 36
description: Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
measure: Blood glucose
time frame: Days 8 and 34
description: Blood glucose will be measured. Blood glucose is reported in mmol/L.
measure: Serum insulin
time frame: Days 8 and 34
description: Serum insulin will be measured. Serum insulin is reported in mIU/L.
measure: Serum c-peptide
time frame: Days 8 and 34
description: Serum c-peptide will be measured. Serum c-peptide is reported in ng/ml.
measure: Non-esterified fatty acids in blood
time frame: Days 8 and 34
description: Non-esterified fatty acids will be measured in blood. Non-esterified fatty acids are reported as mEQ/L.
measure: Triglycerides in blood
time frame: Days 8 and 34
description: Triglycerides will be measured. Triglycerides are reported as mmol/L.
arm group label: Whole Grain Oat
arm group type: Other
description: Volunteers will consume a breakfast meal containing whole grain oats after 7 days of a whole grain free diet.
arm group label: Whole Grain Wheat
arm group type: Other
description: Volunteers will consume a breakfast meal containing whole grain wheat after 7 days of a whole grain free diet.
intervention type: Other
intervention name: Whole grain oats
description: A meal containing whole grain oats
arm group label: Whole Grain Oat
intervention type: Other
intervention name: Whole grain wheat
description: A meal containing whole grain wheat
arm group label: Whole Grain Wheat
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
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