<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/NCT02186353</url>
  </required_header>
  <id_info>
    <org_study_id>P00009343</org_study_id>
    <nct_id>NCT02186353</nct_id>
  </id_info>
  <brief_title>Processing Responses of Grains (PRO-Grains) Study</brief_title>
  <official_title>Effect of Intact vs. Highly Processed Whole Grains on Insulin Sensitivity and Other Cardiometabolic Risk Factors in Hyperinsulinemic Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kansas State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <brief_summary>
    <textblock>
      The primary objective of this pilot study will be to examine the effects of consuming whole&#xD;
      grains, differing in the degree of processing, on insulin sensitivity and other&#xD;
      cardiometabolic risk factors. The overall aim will be to assess feasibility of the test diets&#xD;
      and to generate preliminary data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this pilot study, the investigators will access feasibility and generate preliminary data&#xD;
      to systematically address a major question in nutrition: Does food processing, specifically&#xD;
      with regard to whole grains (WGs), have an independent effect on outcomes related to diabetes&#xD;
      and cardiovascular disease? Whole grains are defined as intact, ground, cracked, or flaked&#xD;
      caryopsis (kernel or seed), where the principal components (bran, endosperm, germ) are&#xD;
      present in the same proportion as the intact caryopsis. In contrast, refined grains (RGs) are&#xD;
      milled to remove the bran and germ, leaving only the endosperm and resulting in lower fiber,&#xD;
      iron, and many B vitamins. Several previous studies have shown that consumption of WGs vs.&#xD;
      RGs improves insulin sensitivity and decreases risk for chronic disease. However, the effects&#xD;
      of consuming WGs may differ depending on degree of processing. While whole grain products&#xD;
      contain the three components of the kernel, we hypothesize that consuming the food containing&#xD;
      the least processed (and least pulverized) kernels may have beneficial effects on metabolism&#xD;
      that decrease disease risk through plausible physiological mechanisms.&#xD;
&#xD;
      The investigators propose a partial feeding study using a randomized 3-period crossover&#xD;
      design to compare the effects of 1) intact or minimally processed whole grains, 2) highly&#xD;
      processed whole grains, and 3) refined grains, each fed for 4 weeks. The primary outcome will&#xD;
      be change in peripheral insulin sensitivity. Secondary outcomes include hepatic insulin&#xD;
      sensitivity, components of the metabolic syndrome and other cardiometabolic risk factors,&#xD;
      arterial stiffness, gut microbiome and fecal short chain fatty acids, and ratings of hunger,&#xD;
      satiation, palatability, and acceptability (gastrointestinal symptoms).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of adequate funding&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in fasting glucose at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in fasting glucose at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in fasting glucose at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in fasting insulin at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in fasting insulin at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in fasting insulin at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in blood lipids at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in blood lipids at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in blood lipids at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in high-sensitivity C-reactive protein at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in high-sensitivity C-reactive protein at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in high-sensitivity C-reactive protein at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in alanine aminotransferase (ALT) at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in alanine aminotransferase (ALT) at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in alanine aminotransferase (ALT) at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in serum metabolomics profile at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in serum metabolomics profile at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in serum metabolomics profile at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in blood pressure at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in blood pressure at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in blood pressure at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in waist circumference at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in waist circumference at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in waist circumference at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in ratings of hunger and satiation at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in ratings of hunger and satiation at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in ratings of hunger and satiation at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in body weight at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in body weight at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in body weight at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in dietary intake at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in dietary intake at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in dietary intake at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in physical activity (assessed by accelerometry) at week 4</measure>
    <time_frame>Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in physical activity (assessed by accelerometry) at week 8</measure>
    <time_frame>Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 0 in physical activity (assessed by accelerometry) at week 12</measure>
    <time_frame>Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Insulin Resistance</condition>
  <condition>Cardiovascular Disease</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Intact/minimally processed whole grains</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Partial feeding study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Highly processed whole grains</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Partial feeding study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Refined grains</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Partial feeding study</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Partial feeding study</intervention_name>
    <description>Provision of all grain foods where only the processing of kernels used to produce the grain foods will differ among test diets. Each participant will be assigned to complete the three 4-week test diets in random sequence.</description>
    <arm_group_label>Highly processed whole grains</arm_group_label>
    <arm_group_label>Intact/minimally processed whole grains</arm_group_label>
    <arm_group_label>Refined grains</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 to 35 years&#xD;
&#xD;
          -  Body mass index ≥ 25 and &lt;40 kg/m2&#xD;
&#xD;
          -  Serum fasting insulin &gt;10 uIU/mL and one of the following metabolic syndrome&#xD;
             components: waist circumference, men: ≥102 cm, women: ≥88 cm; triglycerides, ≥150&#xD;
             mg/dL; HDL-C, men: &lt;40 mg/dL , women: &lt;50 mg/dL; systolic blood pressure ≥130 or&#xD;
             diastolic blood pressure ≥85 mmHg; or fasting glucose, ≥100 mg/dL&#xD;
&#xD;
          -  Medical clearance from a primary care provider to rule out any major medical illness,&#xD;
             disability, or disorder (e.g., liver disease, renal failure, cancer)&#xD;
&#xD;
          -  Access to a working telephone or cell phone&#xD;
&#xD;
          -  Willingness to eat the grain foods provided during participation&#xD;
&#xD;
          -  If female, regular menstrual cycles (defined as 26-30 days, ±1 day full flow, i.e. 26&#xD;
             to 30 days between cycles; no more than one day variation in the duration of menstrual&#xD;
             flow)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing major medical illness by medical history or laboratory screening tests&#xD;
&#xD;
          -  Allergy or sensitivity to gluten (self-reported or physician diagnosed)&#xD;
&#xD;
          -  &gt;5% change in weight within previous 6 months&#xD;
&#xD;
          -  Current smoking (1 cigarette in the past week)&#xD;
&#xD;
          -  Major surgery within the previous 6 months&#xD;
&#xD;
          -  Physical, mental, or cognitive handicaps that prevent participation.&#xD;
&#xD;
          -  Alcohol intake &gt;7 drinks per week&#xD;
&#xD;
          -  Use of medications that may affect study outcomes&#xD;
&#xD;
          -  Use of antibiotics within the previous 3 months (in those who agree to complete the&#xD;
             analyses of gut microbiome and fecal short chain fatty acids)&#xD;
&#xD;
          -  Use of illegal drugs&#xD;
&#xD;
          -  Plans to be away from home for 1 week or longer during the study period (e.g.,&#xD;
             vacation, relocation)&#xD;
&#xD;
          -  Another member of the family (first degree relative) or household participating in the&#xD;
             study&#xD;
&#xD;
          -  If female, pregnancy or lactation during prior 12 months, plans to become pregnant&#xD;
             during the study period, change in oral contraceptives within 3 months, or irregular&#xD;
             menstrual cycle frequency (&lt;10 bleeds/year)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia MW Wong, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David S Ludwig, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cara B Ebbeling, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>June 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Julia Wong</investigator_full_name>
    <investigator_title>Instructor in Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Whole grains</keyword>
  <keyword>Food processing</keyword>
  <keyword>Cardiometabolic risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <!-- 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/NCT02186353
org study id: P00009343
nct id: NCT02186353
lead sponsor: 
collaborator: 
The primary objective of this pilot study will be to examine the effects of consuming whole
      grains, differing in the degree of processing, on insulin sensitivity and other
      cardiometabolic risk factors. The overall aim will be to assess feasibility of the test diets
      and to generate preliminary data.
In this pilot study, the investigators will access feasibility and generate preliminary data
      to systematically address a major question in nutrition: Does food processing, specifically
      with regard to whole grains (WGs), have an independent effect on outcomes related to diabetes
      and cardiovascular disease? Whole grains are defined as intact, ground, cracked, or flaked
      caryopsis (kernel or seed), where the principal components (bran, endosperm, germ) are
      present in the same proportion as the intact caryopsis. In contrast, refined grains (RGs) are
      milled to remove the bran and germ, leaving only the endosperm and resulting in lower fiber,
      iron, and many B vitamins. Several previous studies have shown that consumption of WGs vs.
      RGs improves insulin sensitivity and decreases risk for chronic disease. However, the effects
      of consuming WGs may differ depending on degree of processing. While whole grain products
      contain the three components of the kernel, we hypothesize that consuming the food containing
      the least processed (and least pulverized) kernels may have beneficial effects on metabolism
      that decrease disease risk through plausible physiological mechanisms.

      The investigators propose a partial feeding study using a randomized 3-period crossover
      design to compare the effects of 1) intact or minimally processed whole grains, 2) highly
      processed whole grains, and 3) refined grains, each fed for 4 weeks. The primary outcome will
      be change in peripheral insulin sensitivity. Secondary outcomes include hepatic insulin
      sensitivity, components of the metabolic syndrome and other cardiometabolic risk factors,
      arterial stiffness, gut microbiome and fecal short chain fatty acids, and ratings of hunger,
      satiation, palatability, and acceptability (gastrointestinal symptoms).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in peripheral insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in hepatic insulin sensitivity (assessed by frequently-sampled oral glucose tolerance test) at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in fasting glucose at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in fasting glucose at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in fasting glucose at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in fasting insulin at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in fasting insulin at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in fasting insulin at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in blood lipids at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in blood lipids at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in blood lipids at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in high-sensitivity C-reactive protein at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in high-sensitivity C-reactive protein at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in high-sensitivity C-reactive protein at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in plasminogen activator inhibitor-1 (PAI-1) at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in alanine aminotransferase (ALT) at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in alanine aminotransferase (ALT) at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in alanine aminotransferase (ALT) at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in serum metabolomics profile at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in serum metabolomics profile at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in serum metabolomics profile at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in blood pressure at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in blood pressure at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in blood pressure at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in waist circumference at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in waist circumference at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in waist circumference at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in arterial stiffness (assessed by carotid-femoral pulse wave velocity) at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in gut microbiome composition (16s rRNA sequencing) and fecal short chain fatty acids at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in ratings of hunger and satiation at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in ratings of hunger and satiation at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in ratings of hunger and satiation at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in ratings of palatability and acceptability (gastrointestinal symptoms) at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in body weight at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in body weight at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in body weight at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in dietary intake at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in dietary intake at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in dietary intake at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in physical activity (assessed by accelerometry) at week 4
time frame: Week 0, Week 4 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in physical activity (assessed by accelerometry) at week 8
time frame: Week 0, Week 8 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
measure: Change from week 0 in physical activity (assessed by accelerometry) at week 12
time frame: Week 0, Week 12 (End of 4-week diet of intact/minimally processed whole grains OR highly processed whole grains OR refined grains)
arm group label: Intact/minimally processed whole grains
arm group type: Experimental
description: Partial feeding study
arm group label: Highly processed whole grains
arm group type: Experimental
description: Partial feeding study
arm group label: Refined grains
arm group type: Active Comparator
description: Partial feeding study
intervention type: Behavioral
intervention name: Partial feeding study
description: Provision of all grain foods where only the processing of kernels used to produce the grain foods will differ among test diets. Each participant will be assigned to complete the three 4-week test diets in random sequence.
arm group label: Highly processed whole grains
arm group label: Intact/minimally processed whole grains
arm group label: Refined grains
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julia MW Wong, PhD, RD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: David S Ludwig, MD, PhD
role: Study Chair
affiliation: Boston Children's Hospital
last name: Cara B Ebbeling, PhD
role: Study Chair
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Julia Wong
investigator title: Instructor in Pediatrics
mesh term: Cardiovascular Diseases
mesh term: Insulin Resistance