<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/NCT03794232</url>
  </required_header>
  <id_info>
    <org_study_id>S-749</org_study_id>
    <nct_id>NCT03794232</nct_id>
  </id_info>
  <brief_title>Effect of Inulin-type Fructose Extracted From Jerusalem Artichoke on Improving Prediabetic State of Type 2 Diabetes</brief_title>
  <official_title>Study on the Mechanisms of Soluble Dietary Fiber Extracted From Jerusalem Artichoke in the Treatment of Pre-type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inuling (Bei Jing) Science and Technology Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Proswell Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Inuling (Bei Jing) Science and Technology Co. Ltd</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>
      The trial was a multicenter, randomized, double-blind, placebo-controlled,&#xD;
      parallel-controlled, exploratory clinical study.Through the intervention of soluble dietary&#xD;
      fiber in the pre-type 2 diabetic population, the change of blood glucose spectrum before and&#xD;
      after intervention can show the effect of this intervention on the outcome, and further&#xD;
      elucidate the effect of soluble dietary fiber intervention on the level of insulin resistance&#xD;
      and its effect on outcome. Helps to prevent the more scientific and effective prevention of&#xD;
      type 2 diabetes from pre-diabetes.&#xD;
&#xD;
      Subjects who met the criteria were randomly divided into the experimental group and the&#xD;
      control group, after 24 weeks of intervention, the incidence of blood sugar reversion to&#xD;
      normal was main observed.The main purpose of this study was to investigate the effect of&#xD;
      soluble dietary fiber treatment regimens on the conversion rate of pre-type 2 diabetes&#xD;
      (converted to normal blood glucose, type 2 diabetes, or stable in the stage of impaired&#xD;
      glucose tolerance). The secondary objective was to study the improvement of insulin&#xD;
      resistance and changes in intestinal flora after intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The soluble dietary fiber (NIUCHANG®) and placebo used in the trial were exclusively produced&#xD;
      by Inuling (Beijing) Technology Co., Ltd. and provided free of charge. During the treatment&#xD;
      period, the treatment group was given oral &quot;NIUCHANG®&quot; (once 15g,once a day)and the control&#xD;
      group was given oral placebo (once15 g, once a day) for 24 weeks.&#xD;
&#xD;
      The test was performed for 12 weeks as a course of treatment。At the end of one course of&#xD;
      treatment, if the glucose tolerance was changed to normal or the blood glucose was stable in&#xD;
      the pre-diabetes phase, the original dose was maintained and continued for 12 weeks. At 24&#xD;
      weeks, patients with normal blood glucose and glucose tolerance tests were followed up for 48&#xD;
      weeks. At the end of one course of treatment, if the blood glucose progresses to the stage of&#xD;
      diabetes, the test is withdrawn and treated according to clinical routine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2016</start_date>
  <completion_date type="Actual">April 4, 2018</completion_date>
  <primary_completion_date type="Actual">April 4, 2018</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of blood sugar reversal to normal after intervention</measure>
    <time_frame>Day 0, Week 24</time_frame>
    <description>Through the intervention of soluble dietary fiber in the pre-diabetic population, the change of blood glucose spectrum before and after intervention can show the effect of this intervention on the outcome, and further elucidate the effect of soluble dietary fiber intervention on the level of insulin resistance and its effect on outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in insulin resistance index</measure>
    <time_frame>Day 0, Week 24</time_frame>
    <description>the incidence of blood sugar reversion to normal was main observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in intestinal flora</measure>
    <time_frame>Day 0, Week1，Week4，Week12，Week 24</time_frame>
    <description>If the subject has had diarrhea or taking antibiotics 2 days before and after the fecal specimen should be taken, wait for the stagnation for 1 week before taking the stool specimen to reduce the interference of external factors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of blood glucose stabilization in pre-diabetes after intervention</measure>
    <time_frame>Day 0, Week12，Week 24</time_frame>
    <description>blood glucose becomes stable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of blood glucose progression to diabetes after intervention</measure>
    <time_frame>Day 0, Week12，Week 24</time_frame>
    <description>reduce incidence of blood glucose progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1C、Glycated Albumin</measure>
    <time_frame>Day 0, Week 24</time_frame>
    <description>Changes of Hemoglobin A1C and Glycated Albumin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The levels of serum insulin</measure>
    <time_frame>Day 0, Week 24</time_frame>
    <description>Insulin levels were measured on an empty stomach, 30 minutes, 60 minutes and 120 minutes after oral administration of 75 g of glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The levels of serum C-peptid</measure>
    <time_frame>Day 0, Week 24</time_frame>
    <description>C-peptide levels were measured on an empty stomach, 30 minutes, 60 minutes and 120 minutes after oral administration of 75 g of glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Day 0, Week12，Week 24</time_frame>
    <description>Changes of body weight.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">246</enrollment>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NIUCHANG（Soluble dietary fiber + prebiotics）：Oral, 1 bag (15g) once a day, taking 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo（inactive drug ingredient）：Oral, 1 bag (15g) once a day, taking 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>NIUCHANG</intervention_name>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The following various situations need to be met at the same time in order to be selected:&#xD;
&#xD;
          -  According to the diagnostic criteria for impaired glucose tolerance in the WHO&#xD;
             Diabetes Diagnosis and Classification Standard in 1999: fasting blood glucose&#xD;
             ≥6.1mmol/L and &lt;7.0mmol/L, blood glucose 2 hours after oral administration of 75g&#xD;
             glucose ≥7.8mmol/L and &lt; 11.1mmol/L;&#xD;
&#xD;
          -  BMI：20kg/㎡ ≤ BMI ≤ 35kg/㎡；&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 70 years old, gender is not limited;&#xD;
&#xD;
          -  Voluntarily participate in the trial and sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any of the following circumstances should be excluded and cannot be selected:&#xD;
&#xD;
          -  Acute cardiovascular and cerebrovascular events or myocardial infarction within 6&#xD;
             months;&#xD;
&#xD;
          -  Laboratory examination: liver function AST or ALT ≥ 2.5 × ULN; renal function Cr &gt; 1.2&#xD;
             × ULN;&#xD;
&#xD;
          -  Those with severe gastrointestinal diseases, such as active peptic ulcer, intestinal&#xD;
             obstruction, etc.; those who have changed the history of normal structure of the&#xD;
             gastrointestinal tract;&#xD;
&#xD;
          -  Hypertensive patients with poor blood pressure control (blood pressure SBP ≥ 160 mmHg&#xD;
             and / or DBP ≥ 100 mmHg);&#xD;
&#xD;
          -  Those with severe blood system diseases;&#xD;
&#xD;
          -  Those with other endocrine system diseases, such as hyperthyroidism or&#xD;
             hypercortisolism;&#xD;
&#xD;
          -  Those who have a stress state or have secondary blood glucose elevation factors (such&#xD;
             as those who take glucocorticoids);&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding, who are planning to be pregnant or who are&#xD;
             not willing to contraception during the study;&#xD;
&#xD;
          -  Drug or other drug abusers;&#xD;
&#xD;
          -  Those who may be allergic to the test drug;&#xD;
&#xD;
          -  Those who have participated in other drug trials within 3 months;&#xD;
&#xD;
          -  Those who are unable to cooperate with mental illness;&#xD;
&#xD;
          -  Other circumstances The investigator believes that it is not suitable for the group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inulin</keyword>
  <keyword>Soluble dietary fiber</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>
  <!-- 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/NCT03794232
org study id: S-749
nct id: NCT03794232
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The trial was a multicenter, randomized, double-blind, placebo-controlled,
      parallel-controlled, exploratory clinical study.Through the intervention of soluble dietary
      fiber in the pre-type 2 diabetic population, the change of blood glucose spectrum before and
      after intervention can show the effect of this intervention on the outcome, and further
      elucidate the effect of soluble dietary fiber intervention on the level of insulin resistance
      and its effect on outcome. Helps to prevent the more scientific and effective prevention of
      type 2 diabetes from pre-diabetes.

      Subjects who met the criteria were randomly divided into the experimental group and the
      control group, after 24 weeks of intervention, the incidence of blood sugar reversion to
      normal was main observed.The main purpose of this study was to investigate the effect of
      soluble dietary fiber treatment regimens on the conversion rate of pre-type 2 diabetes
      (converted to normal blood glucose, type 2 diabetes, or stable in the stage of impaired
      glucose tolerance). The secondary objective was to study the improvement of insulin
      resistance and changes in intestinal flora after intervention.
The soluble dietary fiber (NIUCHANG®) and placebo used in the trial were exclusively produced
      by Inuling (Beijing) Technology Co., Ltd. and provided free of charge. During the treatment
      period, the treatment group was given oral "NIUCHANG®" (once 15g,once a day)and the control
      group was given oral placebo (once15 g, once a day) for 24 weeks.

      The test was performed for 12 weeks as a course of treatment。At the end of one course of
      treatment, if the glucose tolerance was changed to normal or the blood glucose was stable in
      the pre-diabetes phase, the original dose was maintained and continued for 12 weeks. At 24
      weeks, patients with normal blood glucose and glucose tolerance tests were followed up for 48
      weeks. At the end of one course of treatment, if the blood glucose progresses to the stage of
      diabetes, the test is withdrawn and treated according to clinical routine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Incidence of blood sugar reversal to normal after intervention
time frame: Day 0, Week 24
description: Through the intervention of soluble dietary fiber in the pre-diabetic population, the change of blood glucose spectrum before and after intervention can show the effect of this intervention on the outcome, and further elucidate the effect of soluble dietary fiber intervention on the level of insulin resistance and its effect on outcome.
measure: Changes in insulin resistance index
time frame: Day 0, Week 24
description: the incidence of blood sugar reversion to normal was main observed
measure: Changes in intestinal flora
time frame: Day 0, Week1，Week4，Week12，Week 24
description: If the subject has had diarrhea or taking antibiotics 2 days before and after the fecal specimen should be taken, wait for the stagnation for 1 week before taking the stool specimen to reduce the interference of external factors.
measure: Incidence of blood glucose stabilization in pre-diabetes after intervention
time frame: Day 0, Week12，Week 24
description: blood glucose becomes stable
measure: Incidence of blood glucose progression to diabetes after intervention
time frame: Day 0, Week12，Week 24
description: reduce incidence of blood glucose progression
measure: Hemoglobin A1C、Glycated Albumin
time frame: Day 0, Week 24
description: Changes of Hemoglobin A1C and Glycated Albumin.
measure: The levels of serum insulin
time frame: Day 0, Week 24
description: Insulin levels were measured on an empty stomach, 30 minutes, 60 minutes and 120 minutes after oral administration of 75 g of glucose.
measure: The levels of serum C-peptid
time frame: Day 0, Week 24
description: C-peptide levels were measured on an empty stomach, 30 minutes, 60 minutes and 120 minutes after oral administration of 75 g of glucose.
measure: Body weight
time frame: Day 0, Week12，Week 24
description: Changes of body weight.
arm group label: Test group
arm group type: Experimental
description: NIUCHANG（Soluble dietary fiber + prebiotics）：Oral, 1 bag (15g) once a day, taking 24 weeks
arm group label: Control group
arm group type: Placebo Comparator
description: Placebo（inactive drug ingredient）：Oral, 1 bag (15g) once a day, taking 24 weeks
intervention type: Dietary Supplement
intervention name: NIUCHANG
arm group label: Test group
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Prediabetic State
mesh term: Glucose Intolerance