<?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>IRCT20150909023957N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-18</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of low calorie diets on inflammation in metabolic syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Modified Alternate-Day Fasting (ADF) in contrast with Calorie Restriction (CR) on inflammatory index and coagulation factors in metabolic syndrome patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20339</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All participants were stratified for body mass index (BMI), age and sex, and were randomly assigned to ADF or CR group for 8 weeks. Randomization was performed using by random-generation software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>metabolic syndrome disease.</hc_freetext>
      <i_freetext>Intervention 1: During 8-week ADF period, subjects consumed very low calorie diet (75% energy restriction) during the 3 fast days (Saturday, Monday, Wednesday) and then ate diet that providing 100% of their energy needs on each feed day (3 days a week). In Friday subjects consumed ad libitum without limitation. ADF subjects were provided with meals on each fast day (ranging from 400-600 kcal), and consumed ad libitum at home on the feed day. The feed and fast days began at midnight each day, and all fast day meals were consumed between 12.00 pm and 2.00 pm to ensure that each subject was undergoing the same duration of fasting All foods were prepared in the home. Subjects were permitted to consume calorie- free foods such as water, tea, green tea, coffee without sugar (&lt; 400 mg caffeine per day), non-starchy vegetable (such as lettuce, cucumberو tomato) and sugar free gums on the fast day and were encouraged to drink plenty of water. Intervention 2: Control group: In Calorie Restriction group, subjects consumed 75% energy needs in each day for 8 weeks and includes 3 main meals and 2 snacks. All subjects in two groups were required to prepare all of their meals at home. The baseline energy requirements for the subjects were assessed by Mifflin equation. Daily dietary carbohydrate, fat and protein accounted for 52, 30 and 18% of ingested energy, respectively.</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>Roghaye sadat razavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Isfahan</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 35 3726 2557</telephone>
        <email>forogh_1369@yahoo.com</email>
        <affiliation>Isfahan University Of Medical Sciences, School of Nutrition and Food Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behnood Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3337 7883</telephone>
        <email>Abbasi.b@srbiau.ac.ir</email>
        <affiliation>Isfahan University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with Metabolic Syndrome
Age 25- 60 years
25 ≤BMI ≤ 40 kg/m2
Body weight more than 5 kg has not changed during the last 3 months.
No fasting for 3 months prior to the beginning of the study
People who are willing to cooperate and answer questions and conduct their tests after explaining the work.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Smoker
History of cardiovascular, pulmonary, renal, thyroid disorders, digestive and liver problems such as hepatitis and ...
Follow a special diet
Severe physical activity
People who have been using drugs that have an effect on weight loss, lipid or glucose metabolism, inflammatory condition and coagulation factors over the past 6 months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>During 8-week ADF period, subjects consumed very low calorie diet (75% energy restriction) during the 3 fast days (Saturday, Monday, Wednesday) and then ate diet that providing 100% of their energy needs on each feed day (3 days a week). In Friday subjects consumed ad libitum without limitation. ADF subjects were provided with meals on each fast day (ranging from 400-600 kcal), and consumed ad libitum at home on the feed day. The feed and fast days began at midnight each day, and all fast day meals were consumed between 12.00 pm and 2.00 pm to ensure that each subject was undergoing the same duration of fasting All foods were prepared in the home. Subjects were permitted to consume calorie- free foods such as water, tea, green tea, coffee without sugar (&lt; 400 mg caffeine per day), non-starchy vegetable (such as lettuce, cucumberو tomato) and sugar free gums on the fast day and were encouraged to drink plenty of water.</i_keyword>
      <i_keyword>Control group: In Calorie Restriction group, subjects consumed 75% energy needs in each day for 8 weeks and includes 3 main meals and 2 snacks. All subjects in two groups were required to prepare all of their meals at home. The baseline energy requirements for the subjects were assessed by Mifflin equation. Daily dietary carbohydrate, fat and protein accounted for 52, 30 and 18% of ingested energy, respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum High- Sensitivity- C- Reactive Protein (Hs- CRP). Timepoint: Two times, before and after dietary intervention. Method of measurement: Serum hs- CRP concentration was assayed using ELISA kits (LDN, Nordhorn, Germany).</prim_outcome>
      <prim_outcome>Fibrinogen. Timepoint: Two times, before and after dietary intervention. Method of measurement: Fibrinogen was also measured using immunoturbidimetry tests (Pars Azmoon. Co., Iran).</prim_outcome>
      <prim_outcome>PT (Prothrombine Time). Timepoint: Two times, before and after dietary intervention. Method of measurement: PT was tested using (PT- based) Prothrombin Clot-Based Assay (sec)  method.</prim_outcome>
      <prim_outcome>A-PTT  (activated limited thromboplastin time). Timepoint: Two times, before and after dietary intervention. Method of measurement: a- PTT was tested using (PT- based) Prothrombin Clot-Based Assay (sec)  method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Food Security Research Center</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, Isfahan University of Medical Sciences</source_name>
      <source_name>Food Security Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-05</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib Avenue, Isfahan University of Medical Sciences, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
