<?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>IRCT20170117032026N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-06</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effect of DASH diet in patients with non-alcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance and oxidative stress in patients with non-alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60887</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The distribution of people between groups is done randomly and a random allocation table created using a computer is used.
Randomization is block type and classification based on gender and body mass index. In this study, individuals will be divided into two groups of intervention and control.</study_design>
      <phase>3</phase>
      <hc_freetext>Non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: DASH (Dietary Approaches to Stop Hypertension) diet. This diet contains 52 to 55% carbohydrates, 16 to 18% protein and 30% fat. The DASH diet is rich in fruits, vegetables, whole grains and low-fat dairy products, and is low in saturated fat, cholesterol and refined grains. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. Everyone in the study is overweight or obese, and for these people the calorie limit of 500 to 700 kcal is less than the calculated energy requirement for each person. 500 kcal for those with a BMI in the range of 25-31 kg / m2 and 700 kcal for those with a BMI of more than 31 kg / m2 will be deducted from the total energy required by each person. An alternative list is provided to patients while educating the patient to facilitate food selection and to observe the principle of diversity between the components of each food group. Intervention 2: Standard diet.</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 decision has been made yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mahdie Hoseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3149 2232</telephone>
        <email>hoseinzade.mahdie@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mahdie Hoseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3149 2232</telephone>
        <email>hoseinzade.mahdie@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1. People 18 to 70 years old 2. People with body mass index 25 to 40 3. Diagnosis based on liver fibroscan 4. Have informed consent.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Pregnancy and lactation 2. Hereditary hemochromatosis 3. History of gingival or gastroplasty bypass surgery 4. Use of hepatotoxic drugs such as calcium channel blockers and high doses of synthetic estrogens 5. Patients with hypothyroidism 6. Cushing's syndrome and 7. Kidney failure Kidney stones 8. Cardiovascular disease 9. People with a history of hepatitis B and C 10. Wilson disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>DB92.Y</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-alcoholic fatty liver disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>DASH (Dietary Approaches to Stop Hypertension) diet. This diet contains 52 to 55% carbohydrates, 16 to 18% protein and 30% fat. The DASH diet is rich in fruits, vegetables, whole grains and low-fat dairy products, and is low in saturated fat, cholesterol and refined grains. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. Everyone in the study is overweight or obese, and for these people the calorie limit of 500 to 700 kcal is less than the calculated energy requirement for each person. 500 kcal for those with a BMI in the range of 25-31 kg / m2 and 700 kcal for those with a BMI of more than 31 kg / m2 will be deducted from the total energy required by each person. An alternative list is provided to patients while educating the patient to facilitate food selection and to observe the principle of diversity between the components of each food group.</i_keyword>
      <i_keyword>Standard diet</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alanine Aminotransferase. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kits.</prim_outcome>
      <prim_outcome>Aspartat transaminase. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kits.</prim_outcome>
      <prim_outcome>Gamma-glutamyl transpeptidase. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kits.</prim_outcome>
      <prim_outcome>Hepatic fibrosis. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Fibroscan.</prim_outcome>
      <prim_outcome>Hepatic steatosis. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Fibroscan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight, fat mass, fat free mass, RMR, body mass index and visceral fat. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Omron digital Scale.</sec_outcome>
      <sec_outcome>Waist,Hip circumference. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>Insulin. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>Catalase. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>Superoxide dismutase. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>PAB. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>High sensitivity C-reactive protein. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>Total cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>High density lipoprotein cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>Low density lipoprotein cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Special kit.</sec_outcome>
      <sec_outcome>Homeostatic model assessment of insulin resistance. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Formula.</sec_outcome>
      <sec_outcome>Insulin sensitivity check index. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Formula.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-30</approval_date>
        <contact_name>Ethics committee of School of Public Health, Shahid Sadoughi University of Medical Sciences,</contact_name>
        <contact_address>Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-30</approval_date>
        <contact_name>Ethics committee of School of Public Health, Shahid Sadoughi University of Medical Sciences,</contact_name>
        <contact_address>Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
