<?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>IRCT20230721058875N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-14</date_registration>
      <primary_sponsor>Shahid Beheshti University</primary_sponsor>
      <public_title>The effect of acute oral ketone supplementation on the response of some appetite-related peptides to one-bout of sprint intermittent exercise in overweight men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acute oral ketone supplementation on the response of some appetite-related peptides to one-bout of sprint intermittent exercise in overweight men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72057</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: After initial evaluations, participants will be randomly allocated into two homogeneous groups (Groups A and B) based on body mass index, maximum oxygen consumption, and aerobic power (Wingate). This randomization process will be carried out using IBM SPSS statistical software through simple randomization. The allocation will be done individually by a third party, ensuring that each participant is assigned to either Group A or Group B to prevent bias in group assignments, Blinding description: Using edible flavorings, food supplement beverages, or glucose placebo beverages, identical in terms of volume, calories, taste, and smell, will be prepared by a third party. These solutions will be dissolved in three hundred milliliters of water and provided to the participants in identical opaque cups. Both the participants and the researchers responsible for data collection and evaluation will not know the order of consumption of the food supplement beverage or glucose placebo beverage.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention involves consuming a single serving of ketone salt (KETO CaNa), a dietary supplement produced by KETO SPORTS in the United States. Each serving weighs 19 grams and contains 11.7 grams of beta-hydroxybutyrate, 1.1 grams of calcium, 1.3 grams of sodium, and 55 calories.  It will be provided to the participants as a solution dissolved in 300 milliliters of water. Intervention 2: Control group: The control group will consume an isocaloric and isovolume placebo consisting of oral glucose and flavoring, dissolved in 300 milliliters of water.</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 obtained from this study will be statistically analyzed, and relevant conclusions will be drawn to form a research article. After undergoing peer review, the article will be published in a scientific journal.
The personal information and details of the participants will not be disclosed in accordance with ethical principles.

When:
after the results are published in a scientific article, the study data will be accessible. This means that the collected data, along with the corresponding results and conclusions, will be made available for reference and utilization by other researchers and interested individuals.

To whom:
Those who have permission to access data and documents include participants in the study, members of the research team, interested persons, and relevant officials. Of course, access to data must be done in compliance with ethical principles, privacy, and relevant laws.

Conditions:
Data and documentation will be used to provide scientific information and evidence for further research, and statistical analysis, confirm or reject hypotheses, develop new theories, evaluate and analyze previous results, and support related decisions in various fields.

Where to obtain:
The data will be readily accessible by simply visiting the website of the scientific journal publishing the research article.

How to obtain:
The data will be readily accessible by simply visiting the website of the scientific journal publishing the research article.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Esmailiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.8, 6th Farhangian alley, Farhangian street, 3th Phase of Andisheh city, Shahriar</address>
        <city>Andisheh city</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33547819580</zip>
        <telephone>+98 21 6557 6309</telephone>
        <email>a.esmailiyan.sbu.ac.ir@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Esmailiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.8, 6th Farhangian alley, Farhangian street, 3th Phase of Andisheh city, Shahriar</address>
        <city>Andisheh city</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33547819580</zip>
        <telephone>+98 21 6557 6309</telephone>
        <email>a.esmailiyan.sbu.ac.ir@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being a male
Being 18 to 35 years old
Having BMI between 25 to 30</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of any kind of injury
Being a regular smoker
Diagnosed with chronic dieses
Followed a ketogenic diet in the past six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention involves consuming a single serving of ketone salt (KETO CaNa), a dietary supplement produced by KETO SPORTS in the United States. Each serving weighs 19 grams and contains 11.7 grams of beta-hydroxybutyrate, 1.1 grams of calcium, 1.3 grams of sodium, and 55 calories.  It will be provided to the participants as a solution dissolved in 300 milliliters of water.</i_keyword>
      <i_keyword>Control group: The control group will consume an isocaloric and isovolume placebo consisting of oral glucose and flavoring, dissolved in 300 milliliters of water.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The appetite rate. Timepoint: The appetite rate will be evaluated just before consuming the beverage and once every thirty minutes for two hours. Method of measurement: The appetite rate will be measured using a visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The calorie intake. Timepoint: The calorie intake in a meal going to be evaluated two hours after consuming the beverage. Method of measurement: The number of calories consumed will be calculated by weighing the amount of food in the container before and after consumption using a digital scale.</sec_outcome>
      <sec_outcome>The blood ghrelin level. Timepoint: The blood ghrelin level will be measured right before consuming the drink, one hour, and two hours after consuming it. Method of measurement: The blood ghrelin level will be checked using Enzyme-Linked Immunosorbent Assay (ELISA) kits.</sec_outcome>
      <sec_outcome>The blood beta-hydroxybutyrate level. Timepoint: The blood beta-hydroxybutyrate level will be measured right before consuming the drink, one hour, and two hours after consuming it. Method of measurement: The blood beta-hydroxybutyrate levels will be checked using biochemical kits.</sec_outcome>
      <sec_outcome>The blood insulin level. Timepoint: The blood insulin level will be measured right before consuming the drink, one hour, and two hours after consuming it. Method of measurement: The blood insulin level will be checked using Enzyme-Linked Immunosorbent Assay (ELISA) kits.</sec_outcome>
      <sec_outcome>The blood leptin level. Timepoint: The blood leptin level will be measured right before consuming the drink, one hour, and two hours after consuming it. Method of measurement: The blood leptin level will be checked using Enzyme-Linked Immunosorbent Assay (ELISA) kits.</sec_outcome>
      <sec_outcome>The blood glucose level. Timepoint: The blood glucose level will be measured right before consuming the drink, one hour, and two hours after consuming it. Method of measurement: The blood glucose level will be checked using biochemical kits.</sec_outcome>
      <sec_outcome>The blood lactate level. Timepoint: The blood lactate level will be measured right before consuming the drink, one hour, and two hours after consuming it. Method of measurement: The blood lactate level will be checked using biochemical kits.</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>self-fund</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-29</approval_date>
        <contact_name>Research Ethics Committees of Shahid Beheshti University</contact_name>
        <contact_address>Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
