<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/NCT01724736</url>
  </required_header>
  <id_info>
    <org_study_id>PrCo Study</org_study_id>
    <nct_id>NCT01724736</nct_id>
  </id_info>
  <brief_title>A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Gastrointestinal Microbiome</brief_title>
  <official_title>A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Fecal Bacteroidetes: Firmicutes Ratio in Pre-Diabetic Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuMe Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NuMe Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie&#xD;
      beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the&#xD;
      Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones&#xD;
      (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and&#xD;
      satiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human gut microbiome appears to be involved in the regulation of metabolic processes,&#xD;
      including digested food components, absorption of fat, metabolism of drugs, and conversion of&#xD;
      indigestible foods or partially digested food ingredients to molecules that may signal&#xD;
      physiological host mechanisms. The gut microbiome is a complex ecosystem of liquor or chime&#xD;
      and microbiota. A change in that habitat may result in microbiota community shifts and&#xD;
      consequential changes in brain-gut regulatory interactions. NM504 is a cobiotic formulation&#xD;
      composed of 3 (generally recognized as safe; GRAS) food ingredients. One ingredient is a&#xD;
      conventional prebiotic fiber. A second ingredient can be fermented but it also is included to&#xD;
      change the viscosity of the biome while protecting the mucosal barrier. The 3rd ingredient is&#xD;
      an antioxidant with poor bioavailability that alters the redox potential of the biome,&#xD;
      selecting for some and against other microbiota growth. In a placebo-controlled&#xD;
      double-blinded intervention this trial will investigate the effect of NM504 on the intestinal&#xD;
      microbiota as well as markers of glucose regulation in 20 prediabetic adults. The&#xD;
      intervention periods last 28 days. Examination of participants will happen at the beginning,&#xD;
      weekly and at the end of intervention and will contain anthropometry; blood samples; fecal&#xD;
      samples; oral glucose tolerance test; meal tolerance test; and scales to assess appetite,&#xD;
      hunger, mood, and bowel habits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the ratio of Bacteroidetes to Firmicuites ratio in the stool comparing the baseline value to the completion of study value.</measure>
    <time_frame>4 weeks</time_frame>
    <description>Abundance of 11 different genera that are characterized in lean and obese individuals will be quantitated and the ratio of abundance of those in the Bacteriodetes phylum to Firmicutes phylum will calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity based on homeostasis model assessment (HOMA)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fasting blood glucose and insulin levels will be used to calculate HOMA-IR (insulin resistance) and to estimate insulin sensitivity at baseline and at the completion of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood glucose</measure>
    <time_frame>Weekly for 4 weeks</time_frame>
    <description>Weekly measurements of fasting blood glucose and serum insulin will be performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Weekly for 4 weeks</time_frame>
    <description>Body weight will be monitored weekly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hunger perception</measure>
    <time_frame>Weekly for 4 weeks</time_frame>
    <description>Visual analog scales to assess appetite and satiety will be used at weekly visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meal tolerance test</measure>
    <time_frame>3 weeks</time_frame>
    <description>A fixed meal will be consumed at 3 weeks. Visual analog scales (VAS) for appetite will be used to measure hunger before the meal. A VAS to assess satiety will be used at completion of the meal. Plasma ghrelin, PYY, GLP-1, glucose and insulin will be measured both before the meal and at 1 hour after consumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Chemistry</measure>
    <time_frame>4 weeks</time_frame>
    <description>Blood will be obtained at baseline and after 4-weeks of treatment to measure lipids, high-sensitivity C-reactive protein (hsCRP) and glycosylated hemoglobin (HgbA1c).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal profiling</measure>
    <time_frame>4 weeks</time_frame>
    <description>Feces will be collected at baseline and after 4 weeks to measure pH, short chain fatty acids, pathogens, branched chain fatty acids and triglycerides to assess changes in the GI microbiome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity based on Oral Glucose Tolerance Testing</measure>
    <time_frame>4 weeks</time_frame>
    <description>An oral glucose tolerance test will be performed at baseline and at the completion of the study to estimate insulin sensitivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>4 weeks</time_frame>
    <description>A standardized mood instrument will be used at baseline and at 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>A survey to measure GI symptoms, changes in bowel habits and changes in stool characteristics will be performed on weekly visits for 4 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Pre Diabetic</condition>
  <arm_group>
    <arm_group_label>Placebo Comparator:</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Celluose 10g - Matches the total dietary fiber content of NM504 as well as the color and taste. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NM504:</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cobiotic formula of GRAS ingredients with a total dietary fiber content of 10g. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Celluose 10g - Matches the total dietary fiber content of NM504 as well as the color and taste. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.</description>
    <arm_group_label>NM504:</arm_group_label>
    <arm_group_label>Placebo Comparator:</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NM504:</intervention_name>
    <description>Cobiotic formula of GRAS ingredients with a total dietary fiber content of 10g. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.</description>
    <arm_group_label>NM504:</arm_group_label>
    <arm_group_label>Placebo Comparator:</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female.&#xD;
&#xD;
          -  Stable body weight.&#xD;
&#xD;
          -  Stable body weight (+ 11 pounds) in the 3 months prior to the study. Between 18 and 70&#xD;
             years of age, inclusive.&#xD;
&#xD;
          -  BMI between 25 and 45 Kg/m2, inclusive. BMI is a measure of your height to weight&#xD;
             ratio. (Body Mass Index).&#xD;
&#xD;
          -  Fasting blood glucose between 100 and 200 mg/dL, inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing.&#xD;
&#xD;
          -  Diabetes or diseases of the liver, pancreas or gastrointestinal tract (except surgery&#xD;
             like cholecystectomy, appendectomy or hiatus hernia repair).&#xD;
&#xD;
          -  Taking a medication for diabetes, or a medication like systemic glucocorticoids that&#xD;
             can affect blood insulin, or a mediation like atypical antipsychotics that alters&#xD;
             affect blood sugar or blood insulin, or a medication like atypical antipsychotics that&#xD;
             alters body weight, or a medication like antibiotics that can change intestinal&#xD;
             bacterial flora, or a medication that alters blood lipids.&#xD;
&#xD;
          -  Past history of Bariatric surgery.&#xD;
&#xD;
          -  Chronic use of proton pump inhibitors or bulk laxatives.&#xD;
&#xD;
          -  Active dependence on alcohol (&gt;14 drinks/week) or illegal drugs.&#xD;
&#xD;
          -  following a weight loss regimen.&#xD;
&#xD;
          -  Body weight over 350 pounds (.160 kg).&#xD;
&#xD;
          -  Any chronic medication [for example: for treatment of conditions like hypothyroidism&#xD;
             (like thyroxine), gout (like allopurinol) or hypertension (like propranolol)] that has&#xD;
             not had a stable dose for 1 month or longer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>July 2014</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microbiome</keyword>
  <keyword>prebiotic</keyword>
  <keyword>cobiotic</keyword>
  <keyword>NM504</keyword>
  <keyword>GI microbiome</keyword>
  <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/NCT01724736
org study id: PrCo Study
nct id: NCT01724736
lead sponsor: 
has dmc: No
This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie
      beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the
      Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones
      (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and
      satiety.
Human gut microbiome appears to be involved in the regulation of metabolic processes,
      including digested food components, absorption of fat, metabolism of drugs, and conversion of
      indigestible foods or partially digested food ingredients to molecules that may signal
      physiological host mechanisms. The gut microbiome is a complex ecosystem of liquor or chime
      and microbiota. A change in that habitat may result in microbiota community shifts and
      consequential changes in brain-gut regulatory interactions. NM504 is a cobiotic formulation
      composed of 3 (generally recognized as safe; GRAS) food ingredients. One ingredient is a
      conventional prebiotic fiber. A second ingredient can be fermented but it also is included to
      change the viscosity of the biome while protecting the mucosal barrier. The 3rd ingredient is
      an antioxidant with poor bioavailability that alters the redox potential of the biome,
      selecting for some and against other microbiota growth. In a placebo-controlled
      double-blinded intervention this trial will investigate the effect of NM504 on the intestinal
      microbiota as well as markers of glucose regulation in 20 prediabetic adults. The
      intervention periods last 28 days. Examination of participants will happen at the beginning,
      weekly and at the end of intervention and will contain anthropometry; blood samples; fecal
      samples; oral glucose tolerance test; meal tolerance test; and scales to assess appetite,
      hunger, mood, and bowel habits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in the ratio of Bacteroidetes to Firmicuites ratio in the stool comparing the baseline value to the completion of study value.
time frame: 4 weeks
description: Abundance of 11 different genera that are characterized in lean and obese individuals will be quantitated and the ratio of abundance of those in the Bacteriodetes phylum to Firmicutes phylum will calculated.
measure: Insulin sensitivity based on homeostasis model assessment (HOMA)
time frame: 4 weeks
description: Fasting blood glucose and insulin levels will be used to calculate HOMA-IR (insulin resistance) and to estimate insulin sensitivity at baseline and at the completion of the study.
measure: Fasting blood glucose
time frame: Weekly for 4 weeks
description: Weekly measurements of fasting blood glucose and serum insulin will be performed.
measure: Body weight
time frame: Weekly for 4 weeks
description: Body weight will be monitored weekly.
measure: Hunger perception
time frame: Weekly for 4 weeks
description: Visual analog scales to assess appetite and satiety will be used at weekly visits.
measure: Meal tolerance test
time frame: 3 weeks
description: A fixed meal will be consumed at 3 weeks. Visual analog scales (VAS) for appetite will be used to measure hunger before the meal. A VAS to assess satiety will be used at completion of the meal. Plasma ghrelin, PYY, GLP-1, glucose and insulin will be measured both before the meal and at 1 hour after consumption.
measure: Clinical Chemistry
time frame: 4 weeks
description: Blood will be obtained at baseline and after 4-weeks of treatment to measure lipids, high-sensitivity C-reactive protein (hsCRP) and glycosylated hemoglobin (HgbA1c).
measure: Fecal profiling
time frame: 4 weeks
description: Feces will be collected at baseline and after 4 weeks to measure pH, short chain fatty acids, pathogens, branched chain fatty acids and triglycerides to assess changes in the GI microbiome.
measure: Insulin sensitivity based on Oral Glucose Tolerance Testing
time frame: 4 weeks
description: An oral glucose tolerance test will be performed at baseline and at the completion of the study to estimate insulin sensitivity.
measure: Mood
time frame: 4 weeks
description: A standardized mood instrument will be used at baseline and at 4 weeks.
measure: Gastrointestinal Symptoms
time frame: 4 weeks
description: A survey to measure GI symptoms, changes in bowel habits and changes in stool characteristics will be performed on weekly visits for 4 weeks.
arm group label: Placebo Comparator:
arm group type: Placebo Comparator
description: Celluose 10g - Matches the total dietary fiber content of NM504 as well as the color and taste. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.
arm group label: NM504:
arm group type: Active Comparator
description: Cobiotic formula of GRAS ingredients with a total dietary fiber content of 10g. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.
intervention type: Drug
intervention name: Placebo
description: Celluose 10g - Matches the total dietary fiber content of NM504 as well as the color and taste. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.
arm group label: NM504:
arm group label: Placebo Comparator:
intervention type: Drug
intervention name: NM504:
description: Cobiotic formula of GRAS ingredients with a total dietary fiber content of 10g. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.
arm group label: NM504:
arm group label: Placebo Comparator:
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prediabetic State