<?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>IRCT20131228015968N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-10</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition</primary_sponsor>
      <public_title>Effects of sumac powder capsule (Rhus coriaria L.) with restricted calorie diet on obesity and depression</public_title>
      <acronym></acronym>
      <scientific_title>Effects of sumac powder capsule (Rhus coriaria L.) with restricted calorie diet on anthropometric indices, body composition, level of inflammatory biomarkers, oxidative stress, appetite hormones, glycemic indices, lipid profile and depression in obese or overweight women with depression</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36888</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are classified into overweight and obese groups based on body mass index and are randomly assigned to one of the sumac group or placebo group. The random grouping of the two groups is done using Stratified Blocked Randomization. Separate randomization is done within each group. The size of the blocks is 4, with two allocations to the intervention group (A) and two allocations to the placebo group (B). With 6 different permutations, AABB, ABAB, BBAA, BABA, ABBA, BAAB will be created, Blinding description: This study is a double blind clinical trial (patients and researchers). In order to implement this study, at the start of the study, a set of cans contains sumac or placebo are coded by a third party (someone other than the researchers) as A and B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Overweight and obesity. Condition 2: depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: daily intake of 3 g sumac powder as 3 capsules of 1000 mg before each meals with weight reduction diet for 12 weeks. Intervention 2: Control group: daily intake of 3 g starch as 3 capsules of 1000 mg before each meals with weight reduction diet for 12 weeks.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nastaran Hariri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd, Qods (Gharb) twon, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2235 7483</telephone>
        <email>nastaranhariri@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical sciences- School of Nutrition</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atoosa Saidpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd., Qods (Gharb) twon, tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2235 7384</telephone>
        <email>atoosa.saidpour@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical sciences- School of Nutrition</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female gender
Willingness to cooperate
Age 20-65 years
Body mass index above 24/9 kg/m2
Mild to moderate depression</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of anti-inflammation drugs (Steroids and non steroids)
Continuous use (more than once a week) of vitamin and mineral supplements with anti-inflammatory and antioxidant properties such as omega-3, vitamin E in the past month
Use of weight loss and appetite suppressants
Use of antidepressants
Diabetes
Cases of various autoimmune inflammatory diseases such as multiple sclerosis, rheumatoid arthritis and ...
Acute gastrointestinal disease (gastric ulcer, bowel disease, etc.)
Chronic kidney or liver disease, with the exception of non-alcoholic fatty liver
Infectious diseases up to 1 month before the start of the study
Acute mental disorders, Bipolar Disorders, Schizophrenia
Weight loss diet in one months ago
Surgery in a recent month
Sensitivity to sumac
Pregnancy
Lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
      <hc_code>F32.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
      <hc_keyword>Major depressive disorder, single episode, mild</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: daily intake of 3 g sumac powder as 3 capsules of 1000 mg before each meals with weight reduction diet for 12 weeks</i_keyword>
      <i_keyword>Control group: daily intake of 3 g starch as 3 capsules of 1000 mg before each meals with weight reduction diet for 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body weight. Timepoint: before intervention, after 6 weeks of intervention and after 12 weeks of intervention. Method of measurement: seca scale.</prim_outcome>
      <prim_outcome>Body Mass Index. Timepoint: Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention. Method of measurement: calculation (kg/m2).</prim_outcome>
      <prim_outcome>Waist Circumference. Timepoint: Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention. Method of measurement: Meter strip.</prim_outcome>
      <prim_outcome>Hip circumference. Timepoint: Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention. Method of measurement: Meter strip.</prim_outcome>
      <prim_outcome>Waist circumference to hip ratio. Timepoint: Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention. Method of measurement: Calculation.</prim_outcome>
      <prim_outcome>Body fat percentage. Timepoint: Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention. Method of measurement: Body Analyzer.</prim_outcome>
      <prim_outcome>Visceral fat. Timepoint: Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention. Method of measurement: Body Analyzer.</prim_outcome>
      <prim_outcome>Body fat free mass. Timepoint: Before intervention, after 6 weeks of intervention and after 12 weeks of intervention. Method of measurement: Body Analyzer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Malondialdehyde. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serum concentration of Leptin. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serum concentration of Neuropeptide Y. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serum  concentration of  hs-CRP. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serum concentration of TNF-alpha. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serum concentration of IL-6. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serum concentration of glucose. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Serum concentration of insulin. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serum concentration of triglyceride. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Serum concentration of total cholesterol. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Serum concentration of High Density Lipoprotein. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>Serum concentration of low density lipoprotein. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: Enzymatic method.</sec_outcome>
      <sec_outcome>HOMA-IR. Timepoint: calculation ([Glucose (mg/dl)]*[Insulin]/405). Method of measurement: Before intervention, twelve weeks after intervention.</sec_outcome>
      <sec_outcome>Appetite. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: simple appetite questionnaire.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before intervention, twelve weeks after intervention. Method of measurement: Beck Depression Inventory.</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>Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-01</approval_date>
        <contact_name>Ethics committee of Institute of Nutrition Research and Food Industry of the country</contact_name>
        <contact_address>No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-01</approval_date>
        <contact_name>Ethics committee of Institute of Nutrition Research and Food Industry of the country</contact_name>
        <contact_address>No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-01</approval_date>
        <contact_name>Ethics committee of Institute of Nutrition Research and Food Industry of the country</contact_name>
        <contact_address>No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
