<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/NCT04490460</url>
  </required_header>
  <id_info>
    <org_study_id>WB01-501</org_study_id>
    <nct_id>NCT04490460</nct_id>
  </id_info>
  <brief_title>Effects on Glycemic Control of WBF-0031 in Subjects With Abnormal Glucose Tolerance</brief_title>
  <official_title>Evaluation of the Safety and Effects on Glycemic Control of Medical Food Formulation WBF-0031 in Subjects With Abnormal Glucose Tolerance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eden Miller</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pendulum Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Diabetes and Obesity Care</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031&#xD;
      in subjects with abnormal glucose control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study aims to investigate if altering the microbiome though Pendulum Glucose&#xD;
      Control supplementation can have implications aimed at maintaining normal blood glucose&#xD;
      levels that are critical for preventing diabetes and its metabolic complications. The&#xD;
      experimental design consists of two-12 week treatment periods in subjects with prediabetes,&#xD;
      as defined by the National Diabetes Prevention Program (DPP) criteria.&#xD;
&#xD;
      The first study period of 12 weeks will be double-blinded, placebo-controlled. The Pendulum&#xD;
      Glucose control and placebo will be in a capsule form and identical in appearance, and&#xD;
      dispensed to each participant according to the randomization schedule in the first 12 weeks.&#xD;
      All subjects will receive the active product (Pendulum Glucose Control) in the second,&#xD;
      subsequent 12 week period.&#xD;
&#xD;
      Fasting total cholesterol, triglycerides, LDL, and HDL cholesterol, Fasting insulin and&#xD;
      Glucose, High sensitivity C Reactive Protein (hsCRP), Chemistry 14, and HbA1c will be&#xD;
      obtained at baseline, and during first and second study period, as well as vital signs of&#xD;
      weight, BP, and waist circumference.&#xD;
&#xD;
      In addition, CGM (Abbott System Freestyle Libre Pro) data collection will be done three times&#xD;
      during the study as noted in Schedule of Events. Baseline Blinded CGM will be performed for&#xD;
      approximately 14 days prior to starting the intervention with Pendulum Glucose Control.&#xD;
      Second Blinded CGM period for approximately 14 days will occur mid-way through the&#xD;
      intervention (weeks 5 and 6) and a third period of Blinded CGM wear will occur during the&#xD;
      last 2 weeks of the intervention (weeks 11 and 12). During the Baseline, study period one and&#xD;
      period 2 a mixed meal tolerance consisting of 2 Boost Shakes will be given on day 5 of each&#xD;
      sensor wear.&#xD;
&#xD;
      At the completion of the study, analysis of the vital signs, laboratory values, CGM data for&#xD;
      average glucose, standard deviation, TIR (time in range), as well as glycemic results of MMT&#xD;
      for each time interval; baseline, study period one, and two.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">February 28, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>Balanced randomization first arm, formulation WBF-0031 and placebo. Second arm all subjects formulation WBF-0031.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Study product was provided for each arm in identical capsules.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Assessment of Adverse Events</measure>
    <time_frame>30 weeks</time_frame>
    <description>Safety assessed via spontaneous adverse events reported during the study period and changes in chemistry 14 panel</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time spent in target blood glucose</measure>
    <time_frame>Three 14 day intervals</time_frame>
    <description>Difference in daily glucose levels as measured by the amount of time spent in target blood glucose for each CGM wear period. Adjustable glucose thresholds will be set as follows:&lt;60 mg/dL, &lt;70 mg/dL, &gt;140 mg/dL, &gt;180 mg/dL and &gt;240 mg/dL. The percent of values above, below, and between these points will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Glucose Area Under the Curve (AUC) from baseline</measure>
    <time_frame>24 weeks</time_frame>
    <description>Twelve and 24 week difference from baseline in total Glucose AUC during a standard Meal Tolerance Test (MMT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental Glucose Area Under the Curve (AUC) from baseline</measure>
    <time_frame>24 weeks</time_frame>
    <description>Twelve and 24 week difference from baseline in incremental Glucose AUC during a standard Meal Tolerance Test (MMT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose peaks</measure>
    <time_frame>30 weeks</time_frame>
    <description>Mean and standard deviation of post-prandial peak glucose and time to peak for each meal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A1c</measure>
    <time_frame>Week 0, Week 12, Week 24</time_frame>
    <description>Improvement in A1c measured as a change in A1c levels from baseline at 12 and 24 weeks. Subjects enrolled in the study will have fasting A1c measurements at the time of enrollment and weeks, 0, 12 and 24 weeks.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Questionnaire</measure>
    <time_frame>Week 0, Week 12, Week 24</time_frame>
    <description>Quality of life questionnaire responses measured at 0, 12 and 24 weeks.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Abnormal Glucose Tolerance</condition>
  <arm_group>
    <arm_group_label>First 12 Weeks</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 capsule administered twice daily with morning and evening meal for 12 weeks. Double blind 50% Placebo capsules identical to those containing WB-0031 and 50% WB-0031</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second 12 Weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 capsule administered twice daily with morning and evening meal for 12 weeks. All participants receiving WB-0031.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>WBF-0031</intervention_name>
    <description>Medical food formulation WBF-0031</description>
    <arm_group_label>First 12 Weeks</arm_group_label>
    <arm_group_label>Second 12 Weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 18-80 years of age&#xD;
&#xD;
          2. BMI &lt; 45 kg/m2&#xD;
&#xD;
          3. Eligible based on a recent (within the past year) blood test meeting one of these&#xD;
             specifications:&#xD;
&#xD;
               1. Fasting glucose of 100 to 125 mg/dl&#xD;
&#xD;
               2. Plasma glucose measured 2 hours after a 75-gram glucose load of 140 to 199 mg/dl&#xD;
&#xD;
               3. A1c of 5.7 to 6.4%&#xD;
&#xD;
               4. Clinically diagnosed gestational diabetes mellitus (GDM) during a previous&#xD;
                  pregnancy (may be self-reported)&#xD;
&#xD;
          4. Willing to comply with study requirements&#xD;
&#xD;
          5. Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known diagnosis of diabetes / taking any medication for the treatment of diabetes&#xD;
             including the off-label use of a GLP-1 receptor agonist, SGLT-2, or metformin) within&#xD;
             the last 3 months for weight loss.&#xD;
&#xD;
          2. Active participation in another lifestyle or behavior change education or research&#xD;
             program (DPP or weight loss program)&#xD;
&#xD;
          3. Current treatment with systemic corticosteroids (topical and nasal steroids are&#xD;
             allowed)&#xD;
&#xD;
          4. Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral&#xD;
             treatment within 30 days prior to study entry&#xD;
&#xD;
          5. Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eden Miller, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diabetes and Obesity Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetes and Obesity Care</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Diabetes and Obesity Care</investigator_affiliation>
    <investigator_full_name>Eden Miller</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>Glucose Intolerance</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/NCT04490460
org study id: WB01-501
nct id: NCT04490460
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031
      in subjects with abnormal glucose control.
The current study aims to investigate if altering the microbiome though Pendulum Glucose
      Control supplementation can have implications aimed at maintaining normal blood glucose
      levels that are critical for preventing diabetes and its metabolic complications. The
      experimental design consists of two-12 week treatment periods in subjects with prediabetes,
      as defined by the National Diabetes Prevention Program (DPP) criteria.

      The first study period of 12 weeks will be double-blinded, placebo-controlled. The Pendulum
      Glucose control and placebo will be in a capsule form and identical in appearance, and
      dispensed to each participant according to the randomization schedule in the first 12 weeks.
      All subjects will receive the active product (Pendulum Glucose Control) in the second,
      subsequent 12 week period.

      Fasting total cholesterol, triglycerides, LDL, and HDL cholesterol, Fasting insulin and
      Glucose, High sensitivity C Reactive Protein (hsCRP), Chemistry 14, and HbA1c will be
      obtained at baseline, and during first and second study period, as well as vital signs of
      weight, BP, and waist circumference.

      In addition, CGM (Abbott System Freestyle Libre Pro) data collection will be done three times
      during the study as noted in Schedule of Events. Baseline Blinded CGM will be performed for
      approximately 14 days prior to starting the intervention with Pendulum Glucose Control.
      Second Blinded CGM period for approximately 14 days will occur mid-way through the
      intervention (weeks 5 and 6) and a third period of Blinded CGM wear will occur during the
      last 2 weeks of the intervention (weeks 11 and 12). During the Baseline, study period one and
      period 2 a mixed meal tolerance consisting of 2 Boost Shakes will be given on day 5 of each
      sensor wear.

      At the completion of the study, analysis of the vital signs, laboratory values, CGM data for
      average glucose, standard deviation, TIR (time in range), as well as glycemic results of MMT
      for each time interval; baseline, study period one, and two.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Balanced randomization first arm, formulation WBF-0031 and placebo. Second arm all subjects formulation WBF-0031.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Study product was provided for each arm in identical capsules.
measure: Safety Assessment of Adverse Events
time frame: 30 weeks
description: Safety assessed via spontaneous adverse events reported during the study period and changes in chemistry 14 panel
measure: Time spent in target blood glucose
time frame: Three 14 day intervals
description: Difference in daily glucose levels as measured by the amount of time spent in target blood glucose for each CGM wear period. Adjustable glucose thresholds will be set as follows:<60 mg/dL, <70 mg/dL, >140 mg/dL, >180 mg/dL and >240 mg/dL. The percent of values above, below, and between these points will be calculated.
measure: Total Glucose Area Under the Curve (AUC) from baseline
time frame: 24 weeks
description: Twelve and 24 week difference from baseline in total Glucose AUC during a standard Meal Tolerance Test (MMT)
measure: Incremental Glucose Area Under the Curve (AUC) from baseline
time frame: 24 weeks
description: Twelve and 24 week difference from baseline in incremental Glucose AUC during a standard Meal Tolerance Test (MMT)
measure: Glucose peaks
time frame: 30 weeks
description: Mean and standard deviation of post-prandial peak glucose and time to peak for each meal
measure: A1c
time frame: Week 0, Week 12, Week 24
description: Improvement in A1c measured as a change in A1c levels from baseline at 12 and 24 weeks. Subjects enrolled in the study will have fasting A1c measurements at the time of enrollment and weeks, 0, 12 and 24 weeks.
measure: Questionnaire
time frame: Week 0, Week 12, Week 24
description: Quality of life questionnaire responses measured at 0, 12 and 24 weeks.
arm group label: First 12 Weeks
arm group type: Placebo Comparator
description: 1 capsule administered twice daily with morning and evening meal for 12 weeks. Double blind 50% Placebo capsules identical to those containing WB-0031 and 50% WB-0031
arm group label: Second 12 Weeks
arm group type: Active Comparator
description: 1 capsule administered twice daily with morning and evening meal for 12 weeks. All participants receiving WB-0031.
intervention type: Dietary Supplement
intervention name: WBF-0031
description: Medical food formulation WBF-0031
arm group label: First 12 Weeks
arm group label: Second 12 Weeks
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eden Miller, D.O.
role: Principal Investigator
affiliation: Diabetes and Obesity Care
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Diabetes and Obesity Care
investigator full name: Eden Miller
investigator title: Principal Investigator
mesh term: Glucose Intolerance
sharing ipd: No