<?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>IRCT20140907019082N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-23</date_registration>
      <primary_sponsor>Vice chancellor for research , Tabriz University of Medical Sciences,</primary_sponsor>
      <public_title>Effect of oral thylakoid intake with low-calorie diet in the treatment of polycystic ovary syndrome</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>The effects of oral thylakoid intake on the metabolic, hormonal and inflammatory parameters in obese women with polycystic ovary syndrome under hypocaloric diet: A randomized double-blinded placebo controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33619</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From among the patients who volunteer to participate in the study, 48 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either thylakoid or placebo group, stratified by age and body mass index (BMI), Blinding description: In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (thylakoid or placebo) received by each group. The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three digit code to each of the two powders (prebiotic and placebo), and keep the codes for himself until the end of the study and data analyses.</study_design>
      <phase>3</phase>
      <hc_freetext>Polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group will receive low-calorie diet with a thylakoid supplement for 12 weeks. Thylakoid supplement is a sachet containing 5 grams of thylakoid (extracted from spinach leaves and made by a researcher) which will be dissolved in a glass of water and used once a day with lunch. Intervention 2: Control group: Patients in this group will receive low-calorie diet and placebo for 12 weeks. Placebo is a sachet containing 5 grams of raw corn starch, which will be dissolved in a glass of water and used once a day with lunch.</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 Its release plan is still unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Pourteymour Fard Tabrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7582</telephone>
        <email>Fateme.Pourteymour@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mahdieh Abbasalizad Farhangi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7582</telephone>
        <email>Abbasalizad_m@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients in our selected population were diagnosed with polycystic ovary syndrome according to Rotterdam diagnostic criteria with the diagnosis of the gynecologist.Having at least two of the three following symptoms:1-Abnormal menstrual cycles (oligomenorrhea, amenorrhea)2- Polycystic ovary in ultrasound3- Clinical signs of hyperandrogenism (Acne- Hirsutism) or biochemical symptoms of hyperandrogenism.
Women aged 20-40 years
Body Mass Index (BMI) range: 30-40 Kg/m2
Moderate activity level
Only OCP consumer (estrogen and progesterone combination pills). All participants will only receive OCP.
Willingness to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy(tendency to become pregnant) or lactation
Having any illness that affecting the studied variables (such as liver disease, thyroid disease, cardiovascular disease, renal disease, gastrointestinal disease , Cushing's syndrome,adrenal hyperplasia, androgen-secreting tumors ,  hyperprolactinemia).
Insulin infusion and intakes of  blood pressure regulating drugs, statins and or drugs that affect insulin resistance (such as metformin), thiazolidinedione, anti androgens.
Using of any vitamin and mineral supplements and  or antioxidants or being under certain diets at least two months before the study.
Any changes in the therapeutic protocol during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</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: Patients in this group will receive low-calorie diet with a thylakoid supplement for 12 weeks. Thylakoid supplement is a sachet containing 5 grams of thylakoid (extracted from spinach leaves and made by a researcher) which will be dissolved in a glass of water and used once a day with lunch.</i_keyword>
      <i_keyword>Control group: Patients in this group will receive low-calorie diet and placebo for 12 weeks. Placebo is a sachet containing 5 grams of raw corn starch, which will be dissolved in a glass of water and used once a day with lunch.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anthropometric indices. Timepoint: Baseline, middle of the study(sixth week) and 12 weeks after intervention. Method of measurement: Seca Scale, stadiometer and strip meter.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Baseline, middle of the study(sixth week) and 12 weeks after intervention. Method of measurement: With the body composition analyzer.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Laboratory evaluation.</prim_outcome>
      <prim_outcome>Fasting Blood Glucose (FBG). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Laboratory evaluation.</prim_outcome>
      <prim_outcome>Serum level of Insulin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Insulin resistance index. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Using formula.</prim_outcome>
      <prim_outcome>Serum levels of free fatty acid (FFA). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: manometer.</prim_outcome>
      <prim_outcome>Serum level of chemerin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Serum level of Omentin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Inflammatory factors. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Serum levels of testosterone. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Serum levels of sex hormone binding glubolin (SHBG). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Serum levels of LH. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Serum levels of FSH. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Serum levels of DHEA-s. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serumic Sirtuin- 1. Timepoint: before and after of study. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Renal function parameters (serum levels of albumin, total protein, creatinine and blood urea nitrogen). Timepoint: before and after of study. Method of measurement: Bromocresol Green(for Albumin), Creatinine (jaffe), others(colorimetric).</sec_outcome>
      <sec_outcome>TAC (total antioxidant capacity). Timepoint: before and after of study. Method of measurement: Colorimetry (by spectrophotometry).</sec_outcome>
      <sec_outcome>Catalase. Timepoint: before and after of study. Method of measurement: Colorimetry (by spectrophotometry).</sec_outcome>
      <sec_outcome>MDA. Timepoint: before and after of study. Method of measurement: Colorimetry (by spectrophotometry).</sec_outcome>
      <sec_outcome>Serum LPS. Timepoint: before and after of study. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serum Brain-Derived Neurotrophic Factor (BDNF). Timepoint: before and after of study. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Serumic S100B. Timepoint: before and after of study. Method of measurement: ELISA.</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 , Tabriz University of Medical Sciences,</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-27</approval_date>
        <contact_name>The Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research &amp; Technology Dept, Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golghast St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
