<?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>IRCT20260607069676N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-20</date_registration>
      <primary_sponsor>Hakim Sabzevari University</primary_sponsor>
      <public_title>The effect combined training and NBS Supplementation on Type 2 Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combined training and Nutrition Bio-shield Superfood (NBS)  Supplementation on some factors affecting Epigenetic Changes in Obese Men with Type 2 Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90644</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: In this study, after selecting the subjects, the subjects will be randomly divided into four groups. Simple Random Assignment is the method used for this purpose. In this method, each subject is assigned independently of the others and with equal probability (25%) to one of the four groups (combined exercise and supplementation, combined exercise and placebo, supplementation, placebo). Random assignment will be done using valid statistical software (such as SPSS, R or Excel) and using a random number generator, Blinding description: In this study, single-blinding will be used to control for potential bias and increase the validity of the findings. This means that subjects will be unaware of the type of intervention they are receiving (supplement or placebo) throughout the study.

To implement this method, the supplement and placebo will be completely similar and indistinguishable in appearance, color, odor, taste, packaging, and method of administration. The products will be distributed by a third party (research collaborator) or using confidential codes so that subjects cannot identify whether they are in the intervention or control group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Combined exercise and NBS supplementation. Perform three sessions of resistance and aerobic exercise and take 10 drops of the supplement daily, equivalent to half a gram. Intervention 2: Intervention group 2: Combined exercise and placebo. Intervention 3: Intervention group3:  NBS supplement. Dosage is the same as in the first group. Intervention 4: Control group: 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:
Some information such as age, gender, weight, medical condition, medications taken

When:
12 months after results are published

To whom:
University professors and students

Conditions:
Use for scientific activities

Where to obtain:
Send email to:
Mohammadkgb79@yahoo.com

How to obtain:
Maximum one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Khosravi Bakhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khaje rabie, 22 bahman Blvd, 22 bahman4/23, number 4</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9199786766</zip>
        <telephone>+98 51 3751 1058</telephone>
        <email>mohammadkgb79@yahoo.com</email>
        <affiliation>Hakim Sabzevari University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Khosravi Bakhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khaje rabie, 22 bahman Blvd, 22 bahman4/23, number 4</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9199786766</zip>
        <telephone>+98 51 3751 1058</telephone>
        <email>mohammadkgb79@yahoo.com</email>
        <affiliation>دانشگاه حکیم سبزواری</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No specific disease such as acute psychiatric disorders, cardiovascular, respiratory diseases, heart surgery, autoimmune diseases and arthritis.
No limiting orthopedic conditions.
Walk independently and be able to perform daily tasks.
The dose of the medication has not changed in the past month.
No history of regular exercise in the past three months
No smoking
Have a medical certificate from a specialist to confirm the ability to perform physical activity
Uncontrolled arrhythmia
Severe hearing impairment
No insulin injection</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Failure to attend the training program for three consecutive sessions
Personal problems
Unwillingness to continue the research
Injury
Engaging in side activities
Use of herbal supplements other than those used in the plan or chemical supplements</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Combined exercise and NBS supplementation. Perform three sessions of resistance and aerobic exercise and take 10 drops of the supplement daily, equivalent to half a gram.</i_keyword>
      <i_keyword>Intervention group 2: Combined exercise and placebo</i_keyword>
      <i_keyword>Intervention group3:  NBS supplement. Dosage is the same as in the first group.</i_keyword>
      <i_keyword>Control group: placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cd36. Timepoint: Before the intervention and 72 hours after the last intervention session. Method of measurement: ELISA laboratory kit.</prim_outcome>
      <prim_outcome>Betaine. Timepoint: Before the intervention and 72 hours after the last intervention session. Method of measurement: ELISA laboratory kit.</prim_outcome>
      <prim_outcome>DNMT3a. Timepoint: Before the intervention and 72 hours after the last intervention session. Method of measurement: ELISA laboratory kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Hakim Sabzevari University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-07</approval_date>
        <contact_name>Ethics Committee of Hakim Sabzevari University</contact_name>
        <contact_address>Sabzevar, Tohidshahr, Pardis University sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
