<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/NCT02999867</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-ZS-1048</org_study_id>
    <nct_id>NCT02999867</nct_id>
  </id_info>
  <brief_title>Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes</brief_title>
  <official_title>Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Metabolic and Nutritional Status of Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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 study is designed to evaluate short term effect of triticale, mung bean and adzuki bean&#xD;
      intervention for health improvement in patients with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and&#xD;
      nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients&#xD;
      will be assigned to control or intervention group (A diet including triticale and mung bean;&#xD;
      B diet including adzuki bean). Blood and urine samples will be collected at baseline and&#xD;
      after 30 days of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">April 15, 2017</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response to the dietary intervention by the change from baseline in blood glucose at 30-day</measure>
    <time_frame>baseline and 30 d</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>response to the dietary intervention by the change from baseline in lipid profile at 30-day</measure>
    <time_frame>baseline and 30 d</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>response to the dietary intervention by the change from baseline in insulin resistance at 30-day</measure>
    <time_frame>baseline and 30 d</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>response to the dietary intervention by the change from baseline in renal function at 30-day</measure>
    <time_frame>baseline and 30 d</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response to the dietary intervention by the change from baseline in liver function at 30-day</measure>
    <time_frame>baseline and 30 d</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response to the dietary intervention by the change from baseline in inflammation result at 30-day</measure>
    <time_frame>baseline and 30 d</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response to the dietary intervention by the change from baseline in folic acid absorption at 30-day</measure>
    <time_frame>baseline and 30 d</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response to the dietary intervention by the change from baseline in iron absorption at 30-day</measure>
    <time_frame>baseline and 30 d</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>M1 triticale and mung bean</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>M1: triticale and mung bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M2 adzuki bean</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>M2: adzuki bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>triticale and mung bean</intervention_name>
    <description>subjects are assigned to intake of triticale and mung bean for 30 days</description>
    <arm_group_label>M1 triticale and mung bean</arm_group_label>
    <other_name>M1 triticale and mung bean</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>adzuki bean</intervention_name>
    <description>subjects are assigned to intake of adzuki bean for 30 days</description>
    <arm_group_label>M2 adzuki bean</arm_group_label>
    <other_name>M2 adzuki bean</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients between the ages of 30 and 65 years&#xD;
&#xD;
          2. patients has been diagnosed as type 2 diabetes mellitus&#xD;
&#xD;
          3. Patients who like to be followed up for 2 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women in pregnancy or lactation.&#xD;
&#xD;
          2. Individuals with a history of severe kidney disease, cardiovascular disease, stroke,&#xD;
             cancer, or psychological disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanping Liu, master</last_name>
    <role>Study Director</role>
    <affiliation>Department of Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</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>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/NCT02999867
org study id: PUMCH-ZS-1048
nct id: NCT02999867
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean
      intervention for health improvement in patients with type 2 diabetes.
The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and
      nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients
      will be assigned to control or intervention group (A diet including triticale and mung bean;
      B diet including adzuki bean). Blood and urine samples will be collected at baseline and
      after 30 days of intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: response to the dietary intervention by the change from baseline in blood glucose at 30-day
time frame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in lipid profile at 30-day
time frame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in insulin resistance at 30-day
time frame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in renal function at 30-day
time frame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in liver function at 30-day
time frame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in inflammation result at 30-day
time frame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in folic acid absorption at 30-day
time frame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in iron absorption at 30-day
time frame: baseline and 30 d
arm group label: M1 triticale and mung bean
arm group type: Experimental
description: M1: triticale and mung bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.
arm group label: M2 adzuki bean
arm group type: Experimental
description: M2: adzuki bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.
intervention type: Dietary Supplement
intervention name: triticale and mung bean
description: subjects are assigned to intake of triticale and mung bean for 30 days
arm group label: M1 triticale and mung bean
other name: M1 triticale and mung bean
intervention type: Dietary Supplement
intervention name: adzuki bean
description: subjects are assigned to intake of adzuki bean for 30 days
arm group label: M2 adzuki bean
other name: M2 adzuki bean
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yanping Liu, master
role: Study Director
affiliation: Department of Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided