<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/NCT04428606</url>
  </required_header>
  <id_info>
    <org_study_id>20-000879</org_study_id>
    <nct_id>NCT04428606</nct_id>
  </id_info>
  <brief_title>Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes</brief_title>
  <acronym>Rheostat</acronym>
  <official_title>Placebo Controlled Pilot Trial to Determine the Effect of Metabolic Rheostat™ and Butyrate Ultra on Hemoglobin A1C and Blood Glucose Levels in Patients With Pre-diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhaoping Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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 aim of this study is to examine the effect of Metabolic Rheostat™ and Butyrate Ultra on&#xD;
      blood glucose levels after a liquid meal challenge in patients with prediabetes. In addition,&#xD;
      the study also aims to look at the effect of Metabolic Rheostat™ and Butyrate Ultra on&#xD;
      weight, HgbA1c, fasting glucose, cholesterol, triglycerides, inflammation markers, and&#xD;
      hormones.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blinded, pilot placebo-controlled trial of two interventions compared to&#xD;
      placebo to determine the effects individually of Metabolic Rheostat™ and Butyrate Ultra daily&#xD;
      consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The entire study&#xD;
      will last 10 weeks including screen. The study will include 20 subjects with prediabetes&#xD;
      treated with Metabolic Rheostat™; 20 subjects with prediabetes treated with Butyrate Ultra&#xD;
      and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules&#xD;
      daily, two capsules three times per day 30 minutes prior to each meal for 56 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</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>
    <intervention_model_description>This is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of Metabolic Rheostat™ and Butyrate Ultra daily consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The study will include 20 subjects with prediabetes treated with Metabolic Rheostat™; 20 subjects with prediabetes treated with Butyrate Ultra and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules daily, two capsules three times per day 30 minutes prior to each meal for 56 days.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra</measure>
    <time_frame>2 hours</time_frame>
    <description>Determine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic impact of Metabolic Rheostat and Butyrate Ultra</measure>
    <time_frame>8 weeks</time_frame>
    <description>Determining the effects of Metabolic Rheostat™ and Butyrate Ultra on gut hormones/incretins (including insulin, C-peptide, glucagon, CCK, GLP-1, GIP, and PYY) using Luminex bead-based technology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings</measure>
    <time_frame>8 weeks</time_frame>
    <description>Exploratory of Food Addiction (FA) using the Yale Food Addiction Scale (0 symptoms to 11 symptoms). Scale indications are: mild = 2-3 symptoms plus impairment or distress, moderate = 4-5 symptoms plus impairment or distress, severe = 6 or more symptoms plus impairment or distress).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>Metabolic Rheostat™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take 6 capsules of Rheostat daily, two capsules three times per day 30 minutes prior to each meal for 56 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Butyrate Ultra</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take 6 capsules Butyrate Ultra daily, two capsules three times per day 30 minutes prior to each meal for 56 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Metabolic Rheostat</intervention_name>
    <description>Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder</description>
    <arm_group_label>Metabolic Rheostat™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Butyrate Ultra</intervention_name>
    <description>An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.</description>
    <arm_group_label>Butyrate Ultra</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects with pre-diabetes.&#xD;
&#xD;
          2. Age&gt; 18 years&#xD;
&#xD;
          3. Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
          4. Willing and able to comply with trial protocol and follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current use of any other investigational agent.&#xD;
&#xD;
          2. Current use of any agent for treatment of diabetes.&#xD;
&#xD;
          3. History of adverse effects, intolerance, or allergic reactions attributed to any&#xD;
             medications.&#xD;
&#xD;
          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          5. Abnormal blood analysis for complete blood count (CBC), hepatic and renal injury&#xD;
             tests.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UCLA Center for Human Nutrition, 1000 Veteran Ave.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Zhaoping Li</investigator_full_name>
    <investigator_title>Chief / Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>glucose control</keyword>
  <keyword>microbiome</keyword>
  <keyword>prediabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04428606
org study id: 20-000879
nct id: NCT04428606
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to examine the effect of Metabolic Rheostat™ and Butyrate Ultra on
      blood glucose levels after a liquid meal challenge in patients with prediabetes. In addition,
      the study also aims to look at the effect of Metabolic Rheostat™ and Butyrate Ultra on
      weight, HgbA1c, fasting glucose, cholesterol, triglycerides, inflammation markers, and
      hormones.
This is a double blinded, pilot placebo-controlled trial of two interventions compared to
      placebo to determine the effects individually of Metabolic Rheostat™ and Butyrate Ultra daily
      consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The entire study
      will last 10 weeks including screen. The study will include 20 subjects with prediabetes
      treated with Metabolic Rheostat™; 20 subjects with prediabetes treated with Butyrate Ultra
      and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules
      daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of Metabolic Rheostat™ and Butyrate Ultra daily consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The study will include 20 subjects with prediabetes treated with Metabolic Rheostat™; 20 subjects with prediabetes treated with Butyrate Ultra and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra
time frame: 2 hours
description: Determine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes.
measure: Metabolic impact of Metabolic Rheostat and Butyrate Ultra
time frame: 8 weeks
description: Determining the effects of Metabolic Rheostat™ and Butyrate Ultra on gut hormones/incretins (including insulin, C-peptide, glucagon, CCK, GLP-1, GIP, and PYY) using Luminex bead-based technology.
measure: Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings
time frame: 8 weeks
description: Exploratory of Food Addiction (FA) using the Yale Food Addiction Scale (0 symptoms to 11 symptoms). Scale indications are: mild = 2-3 symptoms plus impairment or distress, moderate = 4-5 symptoms plus impairment or distress, severe = 6 or more symptoms plus impairment or distress).
arm group label: Metabolic Rheostat™
arm group type: Experimental
description: Participants will take 6 capsules of Rheostat daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
arm group label: Butyrate Ultra
arm group type: Experimental
description: Participants will take 6 capsules Butyrate Ultra daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
intervention type: Dietary Supplement
intervention name: Metabolic Rheostat
description: Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder
arm group label: Metabolic Rheostat™
intervention type: Dietary Supplement
intervention name: Butyrate Ultra
description: An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.
arm group label: Butyrate Ultra
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Zhaoping Li
investigator title: Chief / Professor of Medicine
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: Undecided