<?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>IRCT20160306026938N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of the combination of caffeine, L-theanine and piperin compared to placebo and pure caffeine in increasing attention</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of capsules containing the combination of caffeine, L-theanine and piperin compared to pure caffeine and placebo in improving attention in healthy people</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>31</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74697</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Blinding description: Participants: They all receive capsules of the same shape, same color, and same smell in all three experiments, and they cannot identify the difference in any way.
Researcher: All the capsules are coded (in the envelope) and the researcher will not know about the nature of the codes of the medicine delivered to the subject and will only hand over the codes to subject to receive the medicine based on thje code from the second researcher.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Attention and concentration deficit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: will receive 1- Caffeine capsule containing 200 milligrams of pure caffeine, 2- placebo (containing 300 mg starch) and 3- Caffeine + theanine + piperine capsule, containing 150 ml of caffeine, 200 mg of theanine and 10 mg of piperine, respectively, without knowing the nature of medicine or placebo, orally with an interval of one week for each capsule. Intervention 2: Intervention group: will receive 1- placebo (containing 300 mg starch), 2- Caffeine capsule containing 200 milligrams of pure caffeine, and 3- Caffeine + theanine + piperine capsule, containing 150 ml of caffeine, 200 mg of theanine and 10 mg of piperine, respectively, without knowing the nature of medicine or placebo, orally with an interval of one week for each capsule. Intervention 3: Intervention group: will receive 1- Caffeine + theanine + piperine capsule, containing 150 ml of caffeine, 200 mg of theanine and 10 mg of piperine 2- Caffeine capsule containing 200 milligrams of pure caffeine, and 3- placebo (containing 300 mg starch), respectively, without knowing the nature of medicine or placebo, orally with an interval of one week for each capsule.</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:
All data can be shared after de-identification.

When:
Access starts from 2026

To whom:
Researchers working in academic and scientific institutions

Conditions:
Any type of analysis on the data is allowed, but they cannot use it as a document for making a supplement or medicine, or to prepare an article, solely based on the results of this study.

Where to obtain:
Dr. Mehdi Vazirian. Address: Advanced Research Laboratory of Pharmacognosy, Second Floor, New Building, Faculty of Pharmacy, Tehran University, Enqebal St., Tehran, Iran. Contact number: 02166959101, E. mail: mehdivazirian@gmail.com.

How to obtain:
Sending the official university application to Dr. Mehdi Vazirian's email, checking the authenticity and authenticity of the submitted application and sending the documents to the applicant's email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Vazirian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 6412 1223</telephone>
        <email>Vazirian_m@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Vazirian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 6412 1223</telephone>
        <email>Vazirian_m@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Regular consumption of tea or coffee (at least five cups per week)
Regular consumption of breakfast
Normal or corrected-to-normal vision
Body mass index between 20 and 30</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or breastfeeding
Having acute diseases (infectious or non-infectious)
Suffering from incurable chronic diseases such as cancer or types of epilepsy
Deficiency of immune system
Smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R41.840</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention and concentration deficit</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: will receive 1- Caffeine capsule containing 200 milligrams of pure caffeine, 2- placebo (containing 300 mg starch) and 3- Caffeine + theanine + piperine capsule, containing 150 ml of caffeine, 200 mg of theanine and 10 mg of piperine, respectively, without knowing the nature of medicine or placebo, orally with an interval of one week for each capsule.</i_keyword>
      <i_keyword>Intervention group: will receive 1- placebo (containing 300 mg starch), 2- Caffeine capsule containing 200 milligrams of pure caffeine, and 3- Caffeine + theanine + piperine capsule, containing 150 ml of caffeine, 200 mg of theanine and 10 mg of piperine, respectively, without knowing the nature of medicine or placebo, orally with an interval of one week for each capsule.</i_keyword>
      <i_keyword>Intervention group: will receive 1- Caffeine + theanine + piperine capsule, containing 150 ml of caffeine, 200 mg of theanine and 10 mg of piperine 2- Caffeine capsule containing 200 milligrams of pure caffeine, and 3- placebo (containing 300 mg starch), respectively, without knowing the nature of medicine or placebo, orally with an interval of one week for each capsule.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total attention score. Timepoint: Measuring attention at the beginning of the study (before the start of the intervention) and half an hour after taking the drug or placebo. Method of measurement: Integrated Visual and Auditory Continuous Performance Test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-19</approval_date>
        <contact_name>Tehran University of Medical Siences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Qods street corner, Keshavarz Blvd, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
