<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/NCT01708694</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 12009</org_study_id>
    <secondary_id>R01DK092575</secondary_id>
    <nct_id>NCT01708694</nct_id>
  </id_info>
  <brief_title>Role of Slowly Digesible Starch on Diabetes Risk Factors</brief_title>
  <acronym>STARCH</acronym>
  <official_title>Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of a slowly digesting starch on gut&#xD;
      bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with&#xD;
      pre-diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a double blind randomized controlled clinical trial, the investigators will test the&#xD;
      effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk&#xD;
      factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with&#xD;
      pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either&#xD;
      the experimental or placebo starch daily for 3 months. The investigators will test the&#xD;
      hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will&#xD;
      improve risk factors for the development of type 2 diabetes (insulin sensitivity and&#xD;
      secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a&#xD;
      change in colonic microbial populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin Sensitivity and Secretion</measure>
    <time_frame>3 months</time_frame>
    <description>Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>3 months</time_frame>
    <description>DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut Microbiota</measure>
    <time_frame>3 months</time_frame>
    <description>Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satiety</measure>
    <time_frame>3 months</time_frame>
    <description>Satiety hormones will be measured following ingestion of a standardized smoothie (Standard Meal Test). Satiety will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hunger</measure>
    <time_frame>3 months</time_frame>
    <description>Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Placebo Starch</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Yogurt with about 45 g/day of placebo starch (amylopectin).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Starch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yogurt with about 45 g/day of slowly digestible starch (amylose).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Amylose</intervention_name>
    <description>One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.</description>
    <arm_group_label>Placebo Starch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Amylopectin</intervention_name>
    <description>The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the &quot;placebo&quot;) for 3 months.</description>
    <arm_group_label>Experimental Starch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Have a body mass index between 30 and 44.9 kg/m2&#xD;
&#xD;
          -  Are 35-65 years of age&#xD;
&#xD;
          -  Have pre-diabetes, which means impaired fasting glucose (IFG)&#xD;
&#xD;
          -  Are willing to complete nutritional and activity questionnaires and 2-3 weeks of&#xD;
             baseline testing&#xD;
&#xD;
          -  Are willing to enroll in the 3-month intervention and maintain the same level of&#xD;
             exercise during the study&#xD;
&#xD;
          -  Are willing to maintain weight throughout the study&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis&#xD;
             (gallstones), or cancer&#xD;
&#xD;
          -  Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL&#xD;
&#xD;
          -  Have an average screening blood pressure &gt; 150/100 mm Hg&#xD;
&#xD;
          -  Are a pre-menopausal woman but do not have a regular menstrual cycle&#xD;
&#xD;
          -  Are pregnant or breastfeeding&#xD;
&#xD;
          -  Chronically use medications including diuretics, steroids, and adrenergic-stimulating&#xD;
             agents&#xD;
&#xD;
          -  Have emotional problems such as clinical depression or other diagnosed psychological&#xD;
             conditions&#xD;
&#xD;
          -  Use hormonal contraceptives, oral or parenteral glucocorticoids, or any other&#xD;
             medication known to influence glucose or insulin homeostasis (balance), within 1 month&#xD;
             of study&#xD;
&#xD;
          -  Have a clinically significant gastrointestinal malabsorption syndrome, chronic&#xD;
             diarrhea, or use antibiotics within one month of study&#xD;
&#xD;
          -  Have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or&#xD;
             hematocrit below the lower limit of normal)&#xD;
&#xD;
          -  Chronically consume alcohol (&gt; 4 servings per day) or actively smoke cigarettes (&gt; 1/4&#xD;
             pack per day)&#xD;
&#xD;
          -  Are on any chronic medication that has not had a stable dose for 1 month or longer&#xD;
&#xD;
          -  Are required to perform of any kind of heavy physical activity&#xD;
&#xD;
          -  Have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Eric Ravussin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</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/NCT01708694
org study id: PBRC 12009
secondary id: R01DK092575
nct id: NCT01708694
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the effect of a slowly digesting starch on gut
      bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with
      pre-diabetes.
In a double blind randomized controlled clinical trial, the investigators will test the
      effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk
      factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with
      pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either
      the experimental or placebo starch daily for 3 months. The investigators will test the
      hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will
      improve risk factors for the development of type 2 diabetes (insulin sensitivity and
      secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a
      change in colonic microbial populations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Insulin Sensitivity and Secretion
time frame: 3 months
description: Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
measure: Body Composition
time frame: 3 months
description: DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.
measure: Gut Microbiota
time frame: 3 months
description: Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
measure: Satiety
time frame: 3 months
description: Satiety hormones will be measured following ingestion of a standardized smoothie (Standard Meal Test). Satiety will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
measure: Hunger
time frame: 3 months
description: Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
arm group label: Placebo Starch
arm group type: Placebo Comparator
description: Yogurt with about 45 g/day of placebo starch (amylopectin).
arm group label: Experimental Starch
arm group type: Experimental
description: Yogurt with about 45 g/day of slowly digestible starch (amylose).
intervention type: Dietary Supplement
intervention name: Amylose
description: One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
arm group label: Placebo Starch
intervention type: Dietary Supplement
intervention name: Amylopectin
description: The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
arm group label: Experimental Starch
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Eric Ravussin
investigator title: Principal Investigator
mesh term: Prediabetic State