<?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>IRCT20220926056046N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-10</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of dark chocolate on depression in menopausal women</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of The Effect of Dark Chocolate 78% on Depression among Menopuasal Women: A Randomized Controled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66537</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Study participants will be assigned to one of the intervention and control groups with a 1:1 allocation ratio using the random block method with a block size of six using the website www.random.org. In order to hide the allocation (Allocation Concealment), the sequence of allocation will be specified by a person not involved in the study using a randomizer, and dark and milk chocolate will be placed inside the foil and in the same packages that are numbered consecutively, Blinding description: The participants, the researcher, the collector and the evaluator of the results will be blinded. The chocolates of both groups will be in the same shape and size and same packaging. a person who was not involved in the sampling will be asked to check the outcomes at the end of the intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Sleep quality. Condition 3: Anthropometric indicators.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group will receive 12 grams of 78% dark chocolate daily for eight weeks. The nutritional content of dark chocolate per 6 grams will be: energy: 32 kcal, carbohydrates: 3.2 grams, fat: 2.03 grams, salt: 0.025 grams, trans fatty acids: 0 grams. The product will be prepared from Chichak Company in Tabriz. Intervention 2: Control group:12 grams of milk chocolate daily for eight weeks. The nutritional content of control group chocolate per 6 grams will be: energy: 32 kcal, carbohydrates: 3.2 grams, fat: 2.03 grams, salt: 0.025 grams, trans fatty acids: 0 grams. The cocoa content of milk chocolates will be less than 2%.The product will be prepared from Iran Chocolate (Chichak) Company in Tabriz.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Participant data is confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Abdoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3478 5229</telephone>
        <email>abdolieelham@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Solmaz Ghanbari Homaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery school, Shariati street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9876598765</zip>
        <telephone>+98 41 3524 5181</telephone>
        <email>homayisolmaz@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 45-65
Being menopausal
Desire to consume dark chocolate
No allergy to cocoa or any of the chocolate components
Having mild or moderate depression based on the Beck Depression Questionnaire and the diagnosis of a clinical psychologist</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cardiovascular disease
diabetes mellitus
Under traetment high blood pressure
Digestive diseases
Liver diseases
Kidney Diseases
Fibrocystic breast problems
Under treatment dyslipidemia
Under treatment neurological or neuropsychological diseases
Under tratment depression
Hormone therapy
Habit of daily consumption of cocoa or coffee products
Habitual use of invigorating drinks
Severe depression based on the Beck's questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.1</hc_code>
      <hc_code>F51</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, moderate</hc_keyword>
      <hc_keyword>Sleep disorders not due to a substance or known physiological condition</hc_keyword>
      <hc_keyword></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: Participants in the intervention group will receive 12 grams of 78% dark chocolate daily for eight weeks. The nutritional content of dark chocolate per 6 grams will be: energy: 32 kcal, carbohydrates: 3.2 grams, fat: 2.03 grams, salt: 0.025 grams, trans fatty acids: 0 grams. The product will be prepared from Chichak Company in Tabriz.</i_keyword>
      <i_keyword>Control group:12 grams of milk chocolate daily for eight weeks. The nutritional content of control group chocolate per 6 grams will be: energy: 32 kcal, carbohydrates: 3.2 grams, fat: 2.03 grams, salt: 0.025 grams, trans fatty acids: 0 grams. The cocoa content of milk chocolates will be less than 2%.The product will be prepared from Iran Chocolate (Chichak) Company in Tabriz.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score. Timepoint: The end of the 8th week after starting to consume chocolate. Method of measurement: Beck Depression Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score of sleep quality. Timepoint: The end of the 8th week after starting to consume chocolate. Method of measurement: Pittsburgh Sleep Quality Index.</sec_outcome>
      <sec_outcome>Anthropometric indices. Timepoint: The end of the 8th week after starting to consume chocolate. Method of measurement: Seca height gauge and scale and tape measure.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-04</approval_date>
        <contact_name>Medical Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research department, third floor, central construction number 2, Tabriz university of medical science, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
