<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/NCT03265184</url>
  </required_header>
  <id_info>
    <org_study_id>NationalNFTI1355</org_study_id>
    <nct_id>NCT03265184</nct_id>
  </id_info>
  <brief_title>Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation</brief_title>
  <official_title>Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: 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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2&#xD;
      diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and&#xD;
      low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA)&#xD;
      which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this&#xD;
      trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and&#xD;
      vascular inflammation in patients having Mets&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 18, 2017</completion_date>
  <primary_completion_date type="Actual">June 12, 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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intercellular adhesion molecule-1 (ICAM-1)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>interleukin-6 (IL-6)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>high sensitivity C-reactive protein (hs-CRP)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>malondialdehyde (MDA)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>green coffee extract</intervention_name>
    <description>Patients in treatment group take 400 mg GCE supplements twice a day for tow month</description>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body mass index of over 25, waist circumference &gt;102 cm in men or &gt;88 cm in&#xD;
             women,Fasting blood glucose &gt;100 mg/dL, Triglycerides (TG) &gt; 150 mg/dL, High density&#xD;
             lipoprotein cholesterol (HDL-C) &lt;50 in women or &lt;40 in men, Systolic blood pressure&#xD;
             (SBP) &gt;130 mmHg and diastolic blood pressure (DBP) &gt;85mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insulin administration for diabetes control, having hypo- or hyperthyroidism, renal&#xD;
             failure or other chronic diseases, regular coffee consumption, pregnancy,&#xD;
             breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements&#xD;
             and obeying unusual weight loss plans&#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>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 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>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Inflammation</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/NCT03265184
org study id: NationalNFTI1355
nct id: NCT03265184
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2
      diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and
      low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA)
      which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this
      trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and
      vascular inflammation in patients having Mets
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: intercellular adhesion molecule-1 (ICAM-1)
time frame: 8 weeks
measure: interleukin-6 (IL-6)
time frame: 8 weeks
measure: high sensitivity C-reactive protein (hs-CRP)
time frame: 8 weeks
measure: malondialdehyde (MDA)
time frame: 8 weeks
arm group label: intervention group
arm group type: Experimental
description: 400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC
arm group label: placebo group
arm group type: Placebo Comparator
description: placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch
intervention type: Dietary Supplement
intervention name: green coffee extract
description: Patients in treatment group take 400 mg GCE supplements twice a day for tow month
arm group label: intervention group
arm group label: placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
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: Metabolic Syndrome
mesh term: Syndrome
mesh term: Inflammation