<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200728048232N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-03</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of green coffee supplement on diabetic</public_title>
      <acronym></acronym>
      <scientific_title>The effect of green coffee supplement on glycemic control, inflammatory index, lipid profile and anthropometry in type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49950</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were assigned to one of the intervention and placebo groups based on Block Randomization method by Random Allocation Software, Blinding description: By preparing a placebo exactly like the supplement consumed, the participants did not know which of the groups they were in.</study_design>
      <phase>2</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Take 800 mg of green coffee supplement daily, two 400 mg tablets daily. Intervention 2: Control group: Receive two placebos daily.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Part of the data, such as information about the main outcome

When:
1399

To whom:
If a similar study is performed

Conditions:
evryone

Where to obtain:
Zahra Moin Jahromi
09228031953
Postal code
7177916419

How to obtain:
send email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohre mazloom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz Razi Blvd. School of Nutrition</address>
        <city>Siraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۳۶ - ۷۱۳۴۸</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>zohreh.mazloom@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Moein jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz Razi Blvd. School of Nutrition</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۳۶ - ۷۱۳۴۸</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>niloufarmoein@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of type 2 diabetes in patients was made  by an associate clinical physician under ADA criteria.
Duration of type 2 diabetes is at least 3 years
The type and dose of drugs used in the last 6 months is constant
No chronic (chronic, renal, hepatic, pulmonary, or chronic or acute inflammatory diseases, especially acute inflammation of the pancreas and endocarditis)No heart disease, short bowel syndrome, allergies and thyroid disease
Do not use any dietary supplements in the last 6 months
No pregnancy and lactation
Willingness to participate in the study
No allergies to green coffee</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy during the study period
Changes in medication dosage during the study period
Occurrence of one of the above diseases during the study period
Dissatisfaction with continuing to participate in the study
Do not take less than 80% of the allocated amount of green coffee tablets or do not follow the study design for more than a week</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with unspecified complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Take 800 mg of green coffee supplement daily, two 400 mg tablets daily</i_keyword>
      <i_keyword>Control group: Receive two placebos daily</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Glu. Timepoint: at the first and end of the study. Method of measurement: Fasting blood glucose by glucose oxidase method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: First week 4 and week 8 study. Method of measurement: Weight of people in light clothing without shoes and in the fasting state was measured by a digital scale (model 703 Seka) with an accuracy of 100 grams.</sec_outcome>
      <sec_outcome>Insulin sensitivity. Timepoint: at the first and end of the study. Method of measurement: HOMA Homeostasis.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: at the first and end of the study. Method of measurement: Triglycerides, cholesterol and LDL by enzymatic and calorimetric methods using Roach II commercial kits, HDL by calorimetric enzymatic method using Cubas Roach commercial kits.</sec_outcome>
      <sec_outcome>Insulin sensitivity. Timepoint: at the first and end of the study. Method of measurement: Insulin was evaluated by chemiluminescence method (40). Insulin concentration was determined using the ELISA kit of the American company Monobind. Also, insulin resistance and its components were calculated using the HOMA Homeostasis Model (Index assessment) before and after the intervention as follows: Fasting insulin (microu / L) x fasting glucose (nmol / L) /22.5.</sec_outcome>
      <sec_outcome>Total antioxidant. Timepoint: at the first and end of the study. Method of measurement: The Ferric Reducing Ability of Plasma method was determined using the main ingredient tripyridyl-S-triazine. Total antioxidant capacity was measured using 40 mM hydrochloric acid, 3-aqueous, 6-aqueous sodium acetate and triazine solution at concentrated Fecl acetic acid at 593 nm.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-12</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>No270.40.Bahonar jonobi shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
