<?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>IRCT20190224042821N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-09</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of chlorella vulgaris algae and HIIT exercises on overweight and obesity</public_title>
      <acronym></acronym>
      <scientific_title>Effect of chlorella vulgaris algae supplementation, HIIT exercises and their combination on the serum levels of PGC-1α, FGF21, SIRT1, nutritional status, body composition and aerobic power in young women with overweight and obesity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37816</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Selection would be simple allocation with blocking, Blinding description: In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (chlorella vulgaris or placebo) received by each group. The person responsible for preparing the supplement  boxes(who is completely unrelated to the study) will be asked to assign a three digit code to each of the two powders (chlorella vulgaris  and placebo), and keep the codes for himself until the end of the study and data analyses.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Participants will receive daily chlorella vulgaris supplement provided by the Iranian's Green Future company (900 mg/day in 300 mg pills after three main meals) and HIIT exercises (three sessions per week for 60 minutes) for 8 weeks. Intervention 2: Intervention group 2: Participants will perform HIIT exercises (three sessions per week for 60 minutes) and they will receive a placebo similar to the supplement provided by the Iranian's Green Future company with the same protocol (three times a day) for 8 weeks. Intervention 3: Intervention group 3: : Participants will receive daily Chlorella Vulgaris  supplement provided by the Iranian's Green future Company (900 mg/day in 300 mg pills after three main meals) for 8 weeks. Intervention 4: Control group:Receive the same placebo with supplements provided by the Iranian's Green Future company with the same protocol (three times a day) for 8 weeks.</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 "No more information is existed"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahzad Sanayei</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>mahzad.sanayei@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali Barzegar</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>barzegarali@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Tendency and the ability of cooperation
The age range of 18 to 35
BMI in the range of overweight to type 1 obesity (25-34.9)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Joint and bone disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</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 1: Participants will receive daily chlorella vulgaris supplement provided by the Iranian's Green Future company (900 mg/day in 300 mg pills after three main meals) and HIIT exercises (three sessions per week for 60 minutes) for 8 weeks</i_keyword>
      <i_keyword>Intervention group 2: Participants will perform HIIT exercises (three sessions per week for 60 minutes) and they will receive a placebo similar to the supplement provided by the Iranian's Green Future company with the same protocol (three times a day) for 8 weeks.</i_keyword>
      <i_keyword>Intervention group 3: : Participants will receive daily Chlorella Vulgaris  supplement provided by the Iranian's Green future Company (900 mg/day in 300 mg pills after three main meals) for 8 weeks</i_keyword>
      <i_keyword>Control group:Receive the same placebo with supplements provided by the Iranian's Green Future company with the same protocol (three times a day) for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to reach the fatigue. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: The time to reach the fatigue or maximum power of a person is done using the Bruce test  with the help of treadmill. The test results are reported in minutes and indicate the cardiovascular power.</prim_outcome>
      <prim_outcome>VO2 maximum or aerobic power. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Maximum oxygen consumption (VO2max) or maximum aerobic power is the highest oxygen content used in extreme exercise and is the most important aerobic fitness index, cardiovascular health and endurance ability. VO2max can be measured by direct and indirect methods. Here using the indirect method, the Bruce test on the treadmill, which measures the VO2max from the time of performance or the maximum power output.</prim_outcome>
      <prim_outcome>Anthropometric measures. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumferences by a tape measure. Calculation of waist to hip ratio (WHR) by dividing waist circumference by hip circumference, and body mass index (BMI) by dividing weight (Kg) by height squared (m2).</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Bioelectrical Impedance Analysis (BIA) to determine Fat mass (FM), Fat free mass (FFM), and Body water (BW).</prim_outcome>
      <prim_outcome>Resting metabolic rate. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Indirect calorimetry.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: It is done using a medical barometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: It is done using a digital barometer.</prim_outcome>
      <prim_outcome>Blood glucose. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total cholesterol, HDL-cholesterol and triglyceride through enzymatic methods and calculation of LDL-cholesterol by Friedewald equation.</prim_outcome>
      <prim_outcome>Blood insulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: By the use of formula.</prim_outcome>
      <prim_outcome>SIRT1. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>FGF21. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>PGC-1alpha. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum Irisin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-05</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Attar Neyshabouri Ave, Golgasht Ave Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
