<?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>IRCT20150205020965N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-19</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of date seed powder in runners</public_title>
      <acronym></acronym>
      <scientific_title>The effect of date seed powder supplementation on the nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53070</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants by using software RAS, after mating based on sex and v2omax, will be divided into two groups of 18 individual  intervention (receiver of date seed powder supplement and physical activity) and control (receiver of placebo and physical activity), Blinding description: Supplement and placebo will be coded with codes 1 and 2. Until the release of the patient study results, the researcher and data analyzer will not be aware of the assigned codes.</study_design>
      <phase>3</phase>
      <hc_freetext>Runners.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: during the two weeks, the intervention group will receive two packets of powder containing 13 grams of date seed powder with high-intensity interval training. One packet of pre-workout powder and one packet of post-workout powder will be added to 150 cc of lukewarm water and consumed after mixing. Intervention 2: Control group: during the two weeks, the control group will receive two packets of powder containing 13 grams of wheat bran with high-intensity interval training. One packet of pre-workout powder and one packet of post-workout powder will be added to 150 cc of lukewarm water and consumed after mixing.</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:
Reporting the results

When:
After finishing the study and publishing the project articles

To whom:
Academic researchers

Conditions:
With permission of Project Researcher and Project Sponsor - Nutrition Research Center

Where to obtain:
Dr. Parvin Dehghan, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences Email: Dehghan.nut@gmail.com Phone: +98 914 471 0299

How to obtain:
The applicant can send an application to the responsible person by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvin Dehghan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7580</telephone>
        <email>dehghan.nut@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Dehghan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7580</telephone>
        <email>dehghan.nut@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 35 years old
Doing two exercises for at least 3 days a week (240 minutes per week) during the last 2 years
Complete health (confirmed by PAR-Q questionnaire under the supervision of a doctor)
The body mass index of 18.5-25
Not receiving date seed powder in the last 3 months
Not doing high-intensity interval training during the last 3 months
Willingness to cooperate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Musculoskeletal injury
Smoking, alcohol consumption
Hormone therapy
Long-term use of drugs
Use of dietary supplements
Pregnancy, lactation
Diabetes, anemia (Hb &lt;13g / dl), cardiovascular disease , infectious diseases, malignancy and cognitive disorders
Intake of antihypertensives, diuretics and antidiabetics</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>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: during the two weeks, the intervention group will receive two packets of powder containing 13 grams of date seed powder with high-intensity interval training. One packet of pre-workout powder and one packet of post-workout powder will be added to 150 cc of lukewarm water and consumed after mixing.</i_keyword>
      <i_keyword>Control group: during the two weeks, the control group will receive two packets of powder containing 13 grams of wheat bran with high-intensity interval training. One packet of pre-workout powder and one packet of post-workout powder will be added to 150 cc of lukewarm water and consumed after mixing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Superoxide dismutase. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>High-sensitivity C-reactive Protein. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Interleukin 10. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Interleukin 6. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Creatine Kinase. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Lactate dehydrogenase. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Sport performance. Timepoint: At baseline and two weeks after baseline. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Glucose. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Insulin-like Growth Factor-1. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Adiponectin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Tumor necrosis factor alpha. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Myoglobin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Irisin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Cortisol. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Brain-Derived Neurotrophic Factor. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>F2-isoprostanes. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>8-Oxo-2'-deoxyguanosine. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>GSH. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Carbonyl protein. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Nitric Oxide. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Total oxidant status. Timepoint: At baseline and two weeks after baseline. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Glutathione peroxidase. Timepoint: At baseline and two weeks after baseline. Method of measurement: kit.</prim_outcome>
      <prim_outcome>Uric acid. Timepoint: At baseline and two weeks after baseline. Method of measurement: kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nutritional status (energy and macronutrients intake). Timepoint: At baseline and two weeks after baseline. Method of measurement: 3-days food intake record.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: At baseline and two weeks after baseline. Method of measurement: (BIA, BC-418 MA).</sec_outcome>
      <sec_outcome>CBC (Complete blood count). Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit.</sec_outcome>
      <sec_outcome>Sleep. Timepoint: At baseline and two weeks after baseline. Method of measurement: Questionnaire.</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>2021-01-25</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
