<?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>IRCT20190303042905N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-31</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of butyrate in obesity</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of butyrate supplementation on the expression levels of PGC-1α, PPARα and UCP1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on a weight loss diet: A Triple- Blind, Randomized, Placebo- Controlled Clinical Trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53968</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on inclusion criteria, 50 patients will randomly allocated to placebo (n = 25) or intervention (n = 25) groups. Block design based on the combined analysis and using packed envelopes is used for randomization. In fact, according to the pattern and using two codes of A and B 6 groups with 4 blocks are selected. This work is repeated in 2 steps. In the end, two A and B codes are assigned to the 2 last patients and the randomization is completed (50 patients), Blinding description: The researchers and patients will not inform of the contents of the packets. A third person of health care does the coding. This person will not aware of the details of the research trial.</study_design>
      <phase>2</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: one butyrate capsule of 600mg/day (made by Body Bio company, USA, containing 550 mg of butyrate and 50 mg sodium hydroxide, medium-chain triglycerides (MCT), hydroxypropyl methylcellulose, and purified water) for 60 days. Intervention 2: Control group: one placebo capsule of 600 mg/day (compounds similar to supplement except for butyrate) for 60 days.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The person's information will be confidential and the results will be as collective statistics</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parichehr Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7853167465</zip>
        <telephone>+98 21 5566 7924</telephone>
        <email>amiriparichehr70@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Ahmad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6163764754</zip>
        <telephone>+98 74 3333 1257</telephone>
        <email>seyedahmadhosseini@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Body mass index (BMI) between 30-40
Both of genders female and male
Age between 18-60 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Kidney diseases, liver failure, heart failure, rheumatic diseases, diabetes, malignancies, and gastrointestinal diseases
Consumption of any product or supplement containing probiotics, prebiotics and antibiotics in the last 1 month
Taking vitamin, fiber, omega-3, antioxidant supplements during the 3 weeks before and during the study
Taking weight-loss drugs and following a weight loss diet for the past six months
History of bariatric surgery
Smoking
Pregnancy, lactation, menopause</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: one butyrate capsule of 600mg/day (made by Body Bio company, USA, containing 550 mg of butyrate and 50 mg sodium hydroxide, medium-chain triglycerides (MCT), hydroxypropyl methylcellulose, and purified water) for 60 days</i_keyword>
      <i_keyword>Control group: one placebo capsule of 600 mg/day (compounds similar to supplement except for butyrate) for 60 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using scales.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using  tape.</prim_outcome>
      <prim_outcome>Body mass index(BMI). Timepoint: Before the intervention and two months after the intervention. Method of measurement: By dividing weight (kg) to height square (m2).</prim_outcome>
      <prim_outcome>Waist to hip ratio(WHR). Timepoint: Before the intervention and two months after the intervention. Method of measurement: Waist circumference/hip circumference.</prim_outcome>
      <prim_outcome>Fat mass(FM). Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using  bioelectrical impedence analyser.</prim_outcome>
      <prim_outcome>Fat free mass(FFM). Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using bioelectrical impedence analyser.</prim_outcome>
      <prim_outcome>Serum level of GLP-1. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Gene expression of PGC-1α. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Gene expression of PPARα. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Gene expression of UCP1. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Serum level of LBP. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.</prim_outcome>
      <prim_outcome>Gene expression of TNF-α. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Gene expression of TLR4. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Gene expression of NFkB. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Population of Lactobacilli in gut microbiota. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Population of Bifidobacteria in gut microbiota. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Population of Lachnospiraceae in gut microbiota. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Real time- PCR.</prim_outcome>
      <prim_outcome>Malondialdehyde(MDA). Timepoint: Before the intervention and two months after the intervention. Method of measurement: MDA kit.</prim_outcome>
      <prim_outcome>Glutathione peroxidase(GPX). Timepoint: Before the intervention and two months after the intervention. Method of measurement: GPX kit.</prim_outcome>
      <prim_outcome>Superoxide dismutase (SOD). Timepoint: Before the intervention and two months after the intervention. Method of measurement: SOD kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum levels of Triglyceride. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>Serum levels of High-Density Lipoprotein cholesterol (HDL-c). Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>Serum levels of High-Density Lipoprotein cholesterol (LDL-c). Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>Serum levels of alanine transaminase (ALT). Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>Serum levels of aspartate aminotransferase (AST). Timepoint: Before the intervention and two months after the intervention. Method of measurement: Using enzymatic kit method.</sec_outcome>
      <sec_outcome>Serum levels of insulin. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.</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>2021-01-27</approval_date>
        <contact_name>The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
