<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/NCT04413357</url>
  </required_header>
  <id_info>
    <org_study_id>19.01.US.HCN</org_study_id>
    <nct_id>NCT04413357</nct_id>
  </id_info>
  <brief_title>Glycemic Response in Persons With Type 2 Diabetes</brief_title>
  <official_title>Plasma Glucose and Insulin Response in Persons With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</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 will be a randomized crossover design with nutrition supplement interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a randomized crossover design with three oral nutrition supplement&#xD;
      interventions. The subjects will be randomized to one of three interventions on three&#xD;
      separate study days, one week apart.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2020</start_date>
  <completion_date type="Actual">August 11, 2020</completion_date>
  <primary_completion_date type="Actual">June 11, 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>
    <intervention_model_description>This will be a randomized crossover design. The subjects will be randomized to one of three interventions on three separate study days, one week apart.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the blood glucose curve</measure>
    <time_frame>Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes</time_frame>
    <description>Area under the blood glucose curve (AUC 0-240 minutes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the insulin curves</measure>
    <time_frame>Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes</time_frame>
    <description>Area under the insulin curves (AUC 0-240)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulinogenic index</measure>
    <time_frame>Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes</time_frame>
    <description>Insulinogenic index [Change in Ins30/Change in Glu30]</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Balanced Nutritional Drink</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balanced Nutritional Drink - DMA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balanced Nutritional Drink - DMB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balanced Nutritional Drink</intervention_name>
    <description>Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.</description>
    <arm_group_label>Balanced Nutritional Drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diabetes Specific, Balanced Nutritional Drink (DMA)</intervention_name>
    <description>Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.</description>
    <arm_group_label>Balanced Nutritional Drink - DMA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diabetes Specific, Balanced Nutritional Drink DMB</intervention_name>
    <description>Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.</description>
    <arm_group_label>Balanced Nutritional Drink - DMB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20-75 years&#xD;
&#xD;
          -  Type 2 diabetes controlled with diet or diet and metformin (Glucophage)&#xD;
&#xD;
          -  Hemoglobin A1C less than 9.0%&#xD;
&#xD;
          -  Fasting blood glucose less than 180 mg&#xD;
&#xD;
          -  Hematocrit levels within normal limits&#xD;
&#xD;
          -  Having obtained his/her informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal thyroid function&#xD;
&#xD;
          -  Creatinine &gt;2.0 mg/dl&#xD;
&#xD;
          -  Potassium &lt;3.5 mEq/l&#xD;
&#xD;
          -  Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting&#xD;
&#xD;
          -  Currently unstable diabetes or under treatment for cancer, heart disease, renal&#xD;
             disease&#xD;
&#xD;
          -  Unable to give informed consent or follow instructions&#xD;
&#xD;
          -  Current insulin therapy or insulin therapy within the past month&#xD;
&#xD;
          -  Patient who are pregnant&#xD;
&#xD;
          -  Allergies to milk, soy or any component of the test product&#xD;
&#xD;
          -  Patient who in the investigators assessment cannot be expected to comply with&#xD;
             treatment&#xD;
&#xD;
          -  Currently participating or having participated in another clinical trial&#xD;
&#xD;
          -  Patients with anemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Krysmaru Araujo Torres, MD</last_name>
    <role>Study Director</role>
    <affiliation>Nestle Health Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orange County Research Center</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413357
org study id: 19.01.US.HCN
nct id: NCT04413357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This will be a randomized crossover design with nutrition supplement interventions.
This will be a randomized crossover design with three oral nutrition supplement
      interventions. The subjects will be randomized to one of three interventions on three
      separate study days, one week apart.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.
measure: Area under the blood glucose curve
time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
description: Area under the blood glucose curve (AUC 0-240 minutes)
measure: Area under the insulin curves
time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
description: Area under the insulin curves (AUC 0-240)
measure: Insulinogenic index
time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
description: Insulinogenic index [Change in Ins30/Change in Glu30]
arm group label: Balanced Nutritional Drink
arm group type: Active Comparator
description: The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.
arm group label: Balanced Nutritional Drink - DMA
arm group type: Active Comparator
description: The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.
arm group label: Balanced Nutritional Drink - DMB
arm group type: Active Comparator
description: The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.
intervention type: Other
intervention name: Balanced Nutritional Drink
description: Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.
arm group label: Balanced Nutritional Drink
intervention type: Other
intervention name: Diabetes Specific, Balanced Nutritional Drink (DMA)
description: Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.
arm group label: Balanced Nutritional Drink - DMA
intervention type: Other
intervention name: Diabetes Specific, Balanced Nutritional Drink DMB
description: Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.
arm group label: Balanced Nutritional Drink - DMB
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Krysmaru Araujo Torres, MD
role: Study Director
affiliation: Nestle Health Science
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No