<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/NCT03299153</url>
  </required_header>
  <id_info>
    <org_study_id>1534</org_study_id>
    <nct_id>NCT03299153</nct_id>
  </id_info>
  <brief_title>The Effects of Barberry Juice Consumption in Patients With Type 2 Diabetes</brief_title>
  <official_title>The Effects of Barberry Juice Consumption on Glycaemic Control, Lipid Profile, Blood Pressure and Oxidative Stress in Patients With Type 2 Diabetes: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Nutrition and Food Technology Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Nutrition and Food Technology Institute</source>
  <oversight_info>
    <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 was to investigate the effect of barberry juice (BJ) as a natural&#xD;
      antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a&#xD;
      randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from &quot;Diabetes&#xD;
      Association of Iran-Babul &quot;. Patients were randomly allocated to either the BJ group (n=23)&#xD;
      who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no&#xD;
      intervention. At the baseline and the end of 8-week intervention, blood pressure and&#xD;
      biochemical markers were conducted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2016</start_date>
  <completion_date type="Actual">August 5, 2017</completion_date>
  <primary_completion_date type="Actual">April 16, 2017</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fasting blood glucose</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>total cholesterol</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>LDL- cholesterol</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL- cholesterol</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic BP</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic BP</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this group were received 200 ml/d barberry juice for tow month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients in this group received no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>barberry juice</intervention_name>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fasting blood glucose&gt;100 mg/dL (5.6 mmol /L)&#xD;
&#xD;
          -  Systolic blood pressure&gt;130 mmHg or diastolic blood pressure&gt;85mmHg&#xD;
&#xD;
          -  Triglycerides&gt; 150 mg/dL (1.7 mmol/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking insulin&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  using antioxidant supplements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Nutrition and Food Technology Institute</investigator_affiliation>
    <investigator_full_name>Dr Azita Hekmatdoost</investigator_full_name>
    <investigator_title>National Nutrition and Food Technology Research Institute</investigator_title>
  </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>
  <!-- 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/NCT03299153
org study id: 1534
nct id: NCT03299153
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the effect of barberry juice (BJ) as a natural
      antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a
      randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from "Diabetes
      Association of Iran-Babul ". Patients were randomly allocated to either the BJ group (n=23)
      who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no
      intervention. At the baseline and the end of 8-week intervention, blood pressure and
      biochemical markers were conducted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: fasting blood glucose
time frame: 8 weeks
measure: total cholesterol
time frame: 8 weeks
measure: LDL- cholesterol
time frame: 8 weeks
measure: HDL- cholesterol
time frame: 8 weeks
measure: Triglyceride
time frame: 8 weeks
measure: HbA1c
time frame: 8 weeks
measure: Systolic BP
time frame: 8 weeks
measure: Diastolic BP
time frame: 8 weeks
arm group label: Intervention group
arm group type: Experimental
description: patients in this group were received 200 ml/d barberry juice for tow month
arm group label: control group
arm group type: No Intervention
description: patients in this group received no intervention
intervention type: Other
intervention name: barberry juice
arm group label: Intervention group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: National Nutrition and Food Technology Institute
investigator full name: Dr Azita Hekmatdoost
investigator title: National Nutrition and Food Technology Research Institute
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2