<?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>IRCT20140907019082N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-20</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aerobic physical activity and cannabis powder consumption in sedentary young men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aerobic physical activity alone and in combination with hemp seed powder consumption on biophysical, metabolic and neurological parameters in sedentary young men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49615</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use block randomization. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all the blocks is the same and we will have 4 blocks in this four-group experiment. The randomization tool is also used from the site www.sealedenvelope.com, which is a site for generating random sequences, in addition to simple randomization, is able to generate random sequences by blocking method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are placed in the envelopes respectively. Are placed. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: In this study, the main researchers (including students, supervisors, and advisors) as well as participants will be unaware of the type of supplement (hemp seed or placebo) received by each group. The person in charge of preparing the supplement packs (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two powders (hemp  seed and placebo) and, until the end of the study and data analysis, Keep the codes with you.</study_design>
      <phase>3</phase>
      <hc_freetext>Sedentary men.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: People in the physical activity group with supplements, take 2 capsules of hemp seed powder a day, one before lunch and one the night before bed, and also work out on a treadmill three times a week. Intervention 2: Intervention group: Instead of hemp seed, people in the physical activity group will take a capsule containing cornstarch, which is similar to a supplement, before lunch and at night before going to bed, and will also work out on a treadmill three times a week. Intervention 3: Intervention group: . People in the supplement group take 2 capsules of hemp seed powder a day, one before lunch and one the night before bed. Intervention 4: Control group: People in the control group will also take capsules containing cornstarch, which will be similar to the supplement, before lunch and at night before bed.</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>Ali Mohammad Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه و علوم غذایی</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۱۶۶۶۱۴۷۱۱</zip>
        <telephone>+98 41 3335 7580</telephone>
        <email>alimrezaei4@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>Male
age 18-40
low active
Inclination to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Use any medication or diet and exercise supplements for at least 2 months before the start of the study
Respiratory disease
Cardiovascular disease and hypertension
Diabetes
Thyroid disease
Nervous disease
Skeletal muscle disease
Autoimmune disease
Skeletal and joint problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: People in the physical activity group with supplements, take 2 capsules of hemp seed powder a day, one before lunch and one the night before bed, and also work out on a treadmill three times a week.</i_keyword>
      <i_keyword>Intervention group: Instead of hemp seed, people in the physical activity group will take a capsule containing cornstarch, which is similar to a supplement, before lunch and at night before going to bed, and will also work out on a treadmill three times a week.</i_keyword>
      <i_keyword>Intervention group: . People in the supplement group take 2 capsules of hemp seed powder a day, one before lunch and one the night before bed.</i_keyword>
      <i_keyword>Control group: People in the control group will also take capsules containing cornstarch, which will be similar to the supplement, before lunch and at night before bed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Biophysical indicators (balance, strength, mental function). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: stabilometer, dynamometer, VTS.</prim_outcome>
      <prim_outcome>Neurological factors BDNF and NPY. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Fasting Blood Glucose (FBG). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Laboratory evaluation.</prim_outcome>
      <prim_outcome>Serum level of Insulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Laboratory evaluation.</prim_outcome>
      <prim_outcome>Insulin resistance index. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using formula.</prim_outcome>
      <prim_outcome>Renal function indicators (total iron-binding capacity, creatinine, urea, uric acid). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Serum electrolytes (total iron-binding capacity, magnesium, iron, calcium, phosphorus). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>High-sensitivity C-reactive protein. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Liver function (ALT, AST, direct bilirubin, ALP, albumin, total bilirubin, total protein). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Lactate dehydrogenase activity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Creatine kinase activity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Testosterone. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Sex hormone binding globulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Oxidative stress status (MDA, SOD, GPX, TAC, Catalase). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELIZA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anthropometric indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Seca Scale, stadiometer and strip meter.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: With the body composition analyzer.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-03</approval_date>
        <contact_name>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>
