<?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>IRCT20180312039055N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-20</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>DASH diet in diabetes complications</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Dietary Approaches to Stop Hypertension (DASH) diet on mental health, sleep, sexual hormones and advanced glycated end products (AGEs) serum levels among type 2 diabetic women: A clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30485</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants divide into control (n= 30) and intervention (n= 30) groups using randomized number table by permuted-block randomization method . Then, individuals block according to age and body mass index (normal, overweight and obese). This study is diet therapy and doesn't have concealing processing.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Diabetes. Condition 3: sleep.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Postmenopausal diabetic patients who adhere to the DASH diet. Intervention in this group of people receiving the DASH diet as a diet rich in antioxidants for three months in which it is recommended to receive vegetables, fruits, nuts and nuts, fish, legumes and low-fat dairy products. In this diet, it is recommended to reduce the consumption of red meat, salt, and salts, as well as sweets. No intervention is given in the medication regimen. People are advised not to change their physical activity before studying. Intervention 2: Control group: Postmenopausal diabetic patients who adhere usual diet. The intervention in this group of people is to receive the usual daily diet and receive the usual recommendations for three months. The amount of calories and nutrients is the same as the intervention group, but differs from the intervention group in terms of the number of food group units. No intervention is given in the medication regimen. People are advised not to change their physical activity before studying.</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 Because of privacy and ethics committee, we can not distribute their information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Leila Azadbakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and dietetics faculty, No 44, Hojjatdoost alley, Naderi Ave, Keshavarz Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>azadbakhtleila@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Leila Azadbakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition and dietetics faculty, No 44, Hojjatdoost alley, Naderi Ave, Keshavarz Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>azadbakhtleila@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Tendency to participate in the study
Patients with type 2 diabetes
Postmenopause individuals (who don't have the period cycle for 12 months)
Persons who dont adhere special diets</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients with cancer, kidney, liver, heart and other specific diseases, patients with depression and other psychological diseases, New events which impact on patients mood
Consumption of OCPs, hormonal supplements and hormone therapy
Esterogen therapy during 3 last months
Smoking
Insulin therapy
Consumption of supplements and vitamins during 2 last months
Patients with depression and other psychological diseases, New events which impact on patients mood</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Postmenopausal diabetic patients who adhere to the DASH diet. Intervention in this group of people receiving the DASH diet as a diet rich in antioxidants for three months in which it is recommended to receive vegetables, fruits, nuts and nuts, fish, legumes and low-fat dairy products. In this diet, it is recommended to reduce the consumption of red meat, salt, and salts, as well as sweets. No intervention is given in the medication regimen. People are advised not to change their physical activity before studying.</i_keyword>
      <i_keyword>Control group: Postmenopausal diabetic patients who adhere usual diet. The intervention in this group of people is to receive the usual daily diet and receive the usual recommendations for three months. The amount of calories and nutrients is the same as the intervention group, but differs from the intervention group in terms of the number of food group units. No intervention is given in the medication regimen. People are advised not to change their physical activity before studying.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Luteinizing Hormone (LH). Timepoint: Before and after intervention (12wk). Method of measurement: Serum levels by ELISA.</prim_outcome>
      <prim_outcome>Follicle Stimulating Hormone (FSH). Timepoint: Before and after intervention (12wk). Method of measurement: Serum levels by ELISA.</prim_outcome>
      <prim_outcome>Sex Hormone Binding Globulin (SHBG). Timepoint: Before and after intervention (12wk). Method of measurement: Serum levels by ELISA.</prim_outcome>
      <prim_outcome>Testestrone. Timepoint: Before and after intervention (12wk). Method of measurement: Serum levels by ELISA.</prim_outcome>
      <prim_outcome>Advanced Glycation End products (AGEs). Timepoint: Before and after intervention (12wk). Method of measurement: Serum levels by ELISA.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Before and after intervention (12wk). Method of measurement: DASS-21 item questionnaire.</prim_outcome>
      <prim_outcome>Sleep status. Timepoint: Before and after intervention (12wk). Method of measurement: Pittsburgh sleep questionnaire index (PSQI).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after intervention (12 wk). Method of measurement: DASS-21 item questionnaire.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before and after intervention (12 wk). Method of measurement: DASS-21 item questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Before and after intervention (12 wk). Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Before and after intervention (12 wk). Method of measurement: inflexible meter.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and after intervention (12 wk). Method of measurement: Digital Sphygmomanometer.</sec_outcome>
      <sec_outcome>Body Mass Index (BMI). Timepoint: Before and after intervention (12 wk). Method of measurement: Weight in kilogram divided to square of height in meter.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-11</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences Research Center, Qods Ave, Keshavarz Blv Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
