<?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>IRCT20230220057464N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-23</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of low-calorie Dietary Approaches to Stop Hypertension diet (DASH) and synbiotic supplement on women with polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of low-calorie Dietary Approaches to Stop Hypertension diet (DASH) and synbiotic supplement on metabolic risk factors, serum levels of some inflammatory, oxidant factors and antimullerin hormone in women with polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68711</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: In this study, blocked randomization method will be used. In this method, even-sized blocks are created, and in these blocks, a quarter of the people in each block will be considered as belonging to one of the four groups. Then, among the created blocks, so many blocks are randomly selected to reach the required sample size, Blinding description: People participating in the study will be studied randomly in one of four groups. The supplement and placebo will be given to people with the same appearance and packaging, so that the people under study and the researcher will not know about the contents of the packages. Finally, the person who will do the evaluation of the results will not know how to allocate people.</study_design>
      <phase>3</phase>
      <hc_freetext>Women with polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: 1- group receiving low-calorie DASH diet + synbiotic supplement (500 mg per day) 2- group receiving low-calorie DASH diet + placebo 3- group receiving standard low-calorie diet + synbiotic supplement Biotic (500 mg per day) 4- group receiving standard low-calorie diet + placebo (control group).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Farahmandpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz, Golestan, Jundishapur University of Medical Sciences, Ahvaz- Faculty of Paramedicine, Nutrition Research Center</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 3311 0000</telephone>
        <email>farahmand901@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Farahmandpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz, Golestan, Jundishapur University of Medical Sciences, Ahvaz- Faculty of Paramedicine, Nutrition Research Center</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 3311 0000</telephone>
        <email>farahmand901@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 45 years
Body mass index between 27-35
Diagnosis and confirmation of polycystic ovary syndrome by an endocrinologist based on the Rotterdam criteria
Not having conditions such as pregnancy, breastfeeding and menopause
Not taking probiotics or synbiotics in the last three months
Not suffering from other causes of hyperandrogenism such as congenital adrenal hyperplasia, Cushing's syndrome, ovarian or adrenal tumor
Not suffering from hypothyroidism
No diabetes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to cooperate
Following special diets</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: 1- group receiving low-calorie DASH diet + synbiotic supplement (500 mg per day) 2- group receiving low-calorie DASH diet + placebo 3- group receiving standard low-calorie diet + synbiotic supplement Biotic (500 mg per day) 4- group receiving standard low-calorie diet + placebo (control group)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>CRP, HBA1C, GSH, AMH, insulin, leptin and testosterone, fasting glucose, TG, HDL-C, TC, LDL-C, visceral obesity index, insulin resistance, insulin sensitivity, AIP and VAI, malondialdehyde. Timepoint: All outcomes will be measured at the beginning of the study and at the end of the 12 weeks of the study. Method of measurement: CRP, HBA1C, GSH, AMH, insulin, leptin and testosterone by ELISA method, fasting glucose, TG, HDL-C, TC by photometric method, LDL-C, visceral obesity index, insulin resistance, insulin sensitivity, AIP and VAI They will be measured using the relevant formulas. Malondialdehyde will be measured by TBARS method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight, BMI, waist circumference, hip circumference, ratio of waist circumference to hip circumference, hirsutism rate, sleep quality, alopecia rate and appetite rate. Timepoint: The beginning of the study and 12 weeks after the start of the intervention (the end of the study). Method of measurement: Weight using a scale. BMI using the formula. Waist circumference, hip circumference, ratio of waist circumference to circumference using a meter, amount of hirsutism, quality of sleep, amount of alopecia, and amount of appetite, respectively, using questionnaires of hirsutism, quality of Pittsburgh sleep, alopecia, and appetite.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-29</approval_date>
        <contact_name>Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Nutrition and Metabolic Diseases Research Center, Jundishapur University of Medical Sciences, Ahvaz, Ahvaz. Golestan Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
