<?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>IRCT20090609002017N32</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-11</date_registration>
      <primary_sponsor>Vice chancellor for research , Tabriz University of Medical Sciences, Nutrition Research Center</primary_sponsor>
      <public_title>Assessment of Oleoylethanolamide supplementation in prevention and treatment of non-alcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of oleoylethanolamide supplementation on the expression of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α,  CEBP- β, IL-6, and IL-10 genes, serum  IL-6, IL-10, hs-CRP, IL-1β, TNF-α, TAC, GSH-Px, SOD, catalase, MDA, ox-LDL, and NRG-4 levels, and body composition in obese patients with non-alcoholic fatty liver disease (NAFLD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31612</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples are assigned to intervention and control groups using simple random design, Blinding description: In this study, the main investigator  and patients will be blind (oleoylethanolamide or placebo) .
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 (oleoylethanolamid and placebo), and keep the codes for himself until the end of the study and data analyses.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: daily 2 capsules including 125 mg oleoylethanolamide. Intervention 2: Control group: daily 2 capsules including 125 mg placebo.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data collected for the primary outcomes will be shared.

When:
access starting 12 months after publication

To whom:
The data will only be available for people working in academic institutions.

Conditions:
The data of the present study will only be accessible by other researchers,  for conducting Meta-analysis.

Where to obtain:
The researchers  (student and her supervisor)

How to obtain:
Request a document via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Helda Tutunchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7580</telephone>
        <email>helda.nutrition@gmail.com</email>
        <affiliation>Nutrition Faculty, Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Alireza Ostadrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutritional faculty, Attar Neyshabouri Street, Golgasht Avenue</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7580</telephone>
        <email>ostadrahimi@tbzmed.ac.ir</email>
        <affiliation>Nutrition Faculty, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ages between 20 to 50 years
body mass index (BMI) 30 to 40 kg/m2
Diagnosis of non-alcoholic fatty liver disease by a liver specialist  based on ultrasound</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Regular use of nonsteroidal anti-inflammatory agents (NSAIDs) and antibiotics
Use of hepatotoxic drugs such as phenytoin, amiodarone, levothyroxine, amoxifene, lithium
Use of  antihypertensive drugs
Using weight loss and lipid-lowering drugs
Use of probiotic and prebiotic supplements; vitamins; minerals; antioxidants; and omega 3 supplements in the last 3 months
Smoking
Pregnancy
Breast-feeding
Menopause
Pathological conditions affecting the liver such as viral hepatitis, acute or chronic hepatic impairment, liver transplantation, acute systemic disease
Gastrointestinal diseases
Diabetes
Heart failure
Thyroid disorders
Kidney Diseases
Haemochromatosis
Wilson's disease
Alpha-1 antitrypsin deficiency
Autoimmune diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: daily 2 capsules including 125 mg oleoylethanolamide</i_keyword>
      <i_keyword>Control group: daily 2 capsules including 125 mg placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gene expression of IL-6. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.</prim_outcome>
      <prim_outcome>Gene expression of IL-10. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Serum levels of IL-6. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.</prim_outcome>
      <prim_outcome>Serum levels of IL-10. Timepoint: Before intervention, and 3months after intervention. Method of measurement: By laboratory ELISA kits.</prim_outcome>
      <prim_outcome>Serum levels of NRG-4. Timepoint: Before intervention, and 3months after intervention. Method of measurement: By laboratory ELISA kits.</prim_outcome>
      <prim_outcome>Gene expression of SIRT1. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.</prim_outcome>
      <prim_outcome>Gene expression of AMPK. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.</prim_outcome>
      <prim_outcome>Gene expression of PGC-1α. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.</prim_outcome>
      <prim_outcome>Gene expression of PPAR-γ. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.</prim_outcome>
      <prim_outcome>Gene expression of CEBP-α. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.</prim_outcome>
      <prim_outcome>Gene expression of CEBP-β. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.</prim_outcome>
      <prim_outcome>Serum levels of hs-CRP. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.</prim_outcome>
      <prim_outcome>Serum levels of IL-1β. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.</prim_outcome>
      <prim_outcome>Serum levels of  TNF-α. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.</prim_outcome>
      <prim_outcome>Levels of total antioxidant capacity (TAC). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By colorimetric method using Randox total antioxidant status kit.</prim_outcome>
      <prim_outcome>Levels of glutathione peroxidase (GSH-Px). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By spectrophotometric method using Ransel and Ransod kits.</prim_outcome>
      <prim_outcome>Levels of superoxide dismutase (SOD). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By spectrophotometric method using Ransel and Ransod kits.</prim_outcome>
      <prim_outcome>Level of malondialdehyde (MDA). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By the spectrophotometric thiobarbituric acid reactive substances (TBARS) method.</prim_outcome>
      <prim_outcome>Levels of catalase activity. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By Aebi's method.</prim_outcome>
      <prim_outcome>Serum levels of oxidized-low density lipoprotein (ox-LDL). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body composition. Timepoint: Before intervention, and 3 months after intervention. Method of measurement: Measurement of body composition, including fat mass, fat free mass and total body water determination using bioelectrical impedance analyser (BIA).</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, Nutrition Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-21</approval_date>
        <contact_name>Ethics Committee Tabriz University of Medical Sciences</contact_name>
        <contact_address>Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-28</approval_date>
        <contact_name>Ethics Committee Tabriz University of Medical Sciences</contact_name>
        <contact_address>Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-31</approval_date>
        <contact_name>Ethics Committee Tabriz University of Medical Sciences</contact_name>
        <contact_address>Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
