<?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>IRCT20231015059733N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-19</date_registration>
      <primary_sponsor>The University of Shahid Behshti</primary_sponsor>
      <public_title>The effect of eight-week sprint exercise snacks a long with caloric restriction on serum bile acids in overweight men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight-week sprint exercise snacks a long with caloric restriction on serum bile acids in overweight men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73238</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before the start of 8 weeks of training, the subjects of the intervention groups of speed exercise snacks training along with caloric restriction and the intervention groups of speed exercise snacks training with a normal diet as a test on a day determined at the place of exercise snacks exercises They will be present. Considering the favorable effects of stair climbing snack exercises on cardio-respiratory fitness, stair climbing snack exercises will be used. According to the available scientific documentation, stair climbing snack exercises are one of the available exercises and similar to people's daily activities. Therefore, the staircase of a selected building similar to the subjects' workplace will be used for training. In the staircase of the training place, in accordance with the national and international standards for the construction of stairs (national and international building regulations) in relation to the number of each step in each section (Flight) and the height of each step (Rise), safety considerations and reducing possible accidents during the implementation of the exercise will be considered After preparing the above preparations and controlling the risk and possibility of falling during training by using relevant safety equipment in the staircase of the training place and determining the number of standard stairs climbed in the all-out intensity of each person, the subjects for two weeks and 3 The weekly session of two-bout speed exercise snacks , following the principle of gradual progress of exercises similar to the main training protocol, and with sufficient familiarity and necessary adaptation to the desired exercises, then he performed his exercises daily for a period of 8 weeks. Every day, in the stairwell of the selected building, climbing the stairs with all-out intensity will be done in two stages (7:00 am and 7:00 pm) for 15 seconds in each bout. In this way, after a 5-minute warm-up including 2 minutes of slow climbing with stairs or steps, 10 jumps in place, 10 lateral lunges and 10 chair squats, they will perform 15 seconds of all-out climbing and After finishing the 15-second bout, they will cool down for 2 to 1 minutes in the form of stretching movements. The total time of the main exercise (speed- exercise snacks ) and warm-up and cool-down will be about 10 minutes. All the subjects in the intervention groups of speed exercise snacks training with caloric restriction and the intervention groups of exercise snack-speed exercise with a normal diet while climbing stairs in the first week without extra load only carried out their exercises by carrying an empty backpack. will give, from the second week according to the table below with an increase in extra load on a weekly basis until the eighth week in the form of carrying a bag containing sand based on a percentage of the subject's body weight, all the steps of the exercise snacks - two-bout speed of stair climbing will be done . Intervention 2: Intervention group: One-week food recall forms and food frequency will be distributed among the subjects. The content of the food plan and the eating habits of the subjects will be determined, the intervention groups will be given speed-exercise snacks with caloric restriction and the control groups will be given a caloric -restricted diet with a reduction of about 25% of the previous daily calorie intake. . In the calorie restriction groups, they will be instructed to receive about 75% of their total energy expenditure. For this purpose, the energy cost of rest will be estimated based on Cunningham's equation and by adding and adjusting the cost of the daily physical activity and non-sports physical activity of the subjects, the energy cost of the total daily cost will be calculated. Then 25% of the estimated calories of daily energy expenditure (resting energy expenditure plus physical activity) is subtracted and according to the positive effects of a high protein diet on weight loss and maintaining muscle mass, the remaining calories are 50% from carbohydrates, 30% It will be distributed from protein and 20% from fat. Then, the meals of each group will be determined and, taking into account the number of each group, several meal plans will be prescribed to the subjects. Intervention 3: Control group: The control group with 25% caloric restriction and the control group with normal diet will not exercise. Intervention 4: Control group: In the normal diet group, energy expenditure and intake will be distributed based on zero caloric balance and the amount of physical activity without weight change in the form of 50% of carbohydrates, 30% of protein and 20% of fat, and the above food plan is also divided into groups It will be prescribed with a normal diet.</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:
After collecting and analyzing the research data, the main data related to bile acids will be shared.

When:
The access period starts one year after the results are published

To whom:
All healthy and sick people

Conditions:
In case of exercise intervention in sick and healthy people

Where to obtain:
Call 0098 9127886036.

How to obtain:
In the first stage, contact and provide the necessary documents to qualify to use the data of this research and then send the information via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Irandoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Evin, Shahid Shahriari Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 29901</telephone>
        <email>hamid.irandoost@gmail.com</email>
        <affiliation>The University of Shahid Behshti</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Irandoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Evin, Shahid Shahriari Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 29901</telephone>
        <email>hamid.irandoost@gmail.com</email>
        <affiliation>The University of Shahid Beheshti</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>healthy men.
Body mass index 25-30 kg/m2.
Not participating in regular exercise training during the past 6 months before the implementation of the research project.
Not taking antibiotics in the last 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of taking illegal drugs and substances
History of specific diseases such as alcoholic or non-alcoholic fatty liver, gallstones, diabetes, cardiovascular failure, metabolic syndrome, gastrointestinal syndrome</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before the start of 8 weeks of training, the subjects of the intervention groups of speed exercise snacks training along with caloric restriction and the intervention groups of speed exercise snacks training with a normal diet as a test on a day determined at the place of exercise snacks exercises They will be present. Considering the favorable effects of stair climbing snack exercises on cardio-respiratory fitness, stair climbing snack exercises will be used. According to the available scientific documentation, stair climbing snack exercises are one of the available exercises and similar to people's daily activities. Therefore, the staircase of a selected building similar to the subjects' workplace will be used for training. In the staircase of the training place, in accordance with the national and international standards for the construction of stairs (national and international building regulations) in relation to the number of each step in each section (Flight) and the height of each step (Rise), safety considerations and reducing possible accidents during the implementation of the exercise will be considered After preparing the above preparations and controlling the risk and possibility of falling during training by using relevant safety equipment in the staircase of the training place and determining the number of standard stairs climbed in the all-out intensity of each person, the subjects for two weeks and 3 The weekly session of two-bout speed exercise snacks , following the principle of gradual progress of exercises similar to the main training protocol, and with sufficient familiarity and necessary adaptation to the desired exercises, then he performed his exercises daily for a period of 8 weeks. Every day, in the stairwell of the selected building, climbing the stairs with all-out intensity will be done in two stages (7:00 am and 7:00 pm) for 15 seconds in each bout. In this way, after a 5-minute warm-up including 2 minutes of slow climbing with stairs or steps, 10 jumps in place, 10 lateral lunges and 10 chair squats, they will perform 15 seconds of all-out climbing and After finishing the 15-second bout, they will cool down for 2 to 1 minutes in the form of stretching movements. The total time of the main exercise (speed- exercise snacks ) and warm-up and cool-down will be about 10 minutes. All the subjects in the intervention groups of speed exercise snacks training with caloric restriction and the intervention groups of exercise snack-speed exercise with a normal diet while climbing stairs in the first week without extra load only carried out their exercises by carrying an empty backpack. will give, from the second week according to the table below with an increase in extra load on a weekly basis until the eighth week in the form of carrying a bag containing sand based on a percentage of the subject's body weight, all the steps of the exercise snacks - two-bout speed of stair climbing will be done .</i_keyword>
      <i_keyword>Intervention group: One-week food recall forms and food frequency will be distributed among the subjects. The content of the food plan and the eating habits of the subjects will be determined, the intervention groups will be given speed-exercise snacks with caloric restriction and the control groups will be given a caloric -restricted diet with a reduction of about 25% of the previous daily calorie intake. . In the calorie restriction groups, they will be instructed to receive about 75% of their total energy expenditure. For this purpose, the energy cost of rest will be estimated based on Cunningham's equation and by adding and adjusting the cost of the daily physical activity and non-sports physical activity of the subjects, the energy cost of the total daily cost will be calculated. Then 25% of the estimated calories of daily energy expenditure (resting energy expenditure plus physical activity) is subtracted and according to the positive effects of a high protein diet on weight loss and maintaining muscle mass, the remaining calories are 50% from carbohydrates, 30% It will be distributed from protein and 20% from fat. Then, the meals of each group will be determined and, taking into account the number of each group, several meal plans will be prescribed to the subjects.</i_keyword>
      <i_keyword>Control group: The control group with 25% caloric restriction and the control group with normal diet will not exercise.</i_keyword>
      <i_keyword>Control group: In the normal diet group, energy expenditure and intake will be distributed based on zero caloric balance and the amount of physical activity without weight change in the form of 50% of carbohydrates, 30% of protein and 20% of fat, and the above food plan is also divided into groups It will be prescribed with a normal diet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bile acids, the final product of cholesterol catabolism, are made by liver cells and stored in the gallbladder. In this research, selected species are included, primary bile acid i.e. chenodeoxycholic acid(CDCA), secondary bile acid i.e. lithocholic acid(LCA), bile acid conjugated with glycine i.e. glycocondeoxycholic acid(GCDCA), bile acid conjugated with taurine i.e. taurosodeoxycholic acid(TUDCA), total bile acids(TBA). Timepoint: before and after 8 weeks of intervention and control. Method of measurement: Liquid chromatography-mass spectrometry (LC-MS/MS) and Enzymatic assays.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fibroblastic growth factor 19 regulates the production of bile acids. Timepoint: before and after 8 weeks of intervention and control. Method of measurement: By ELISA method.</sec_outcome>
      <sec_outcome>7-alpha hydroxycholesten-3-1 is a confirmed indicator of CYP7A1 enzyme activity of cholesterol 7 alpha hydroxylase (an enzyme that leads to the production of bile acids from cholesterol). Timepoint: before and after 8 weeks of intervention and control. Method of measurement: Liquid chromatography-mass spectrometry (LC-MS/MS).</sec_outcome>
      <sec_outcome>The maximum effect of insulin is defined by the response and its necessary concentration to create half of the maximum effect,  is insulin sensitivity . Timepoint: before and after 8 weeks of intervention and control. Method of measurement: By evaluating the homeostasis model (HOMA-IR), insulin sensitivity will be obtained using serum glucose and insulin concentrations.</sec_outcome>
      <sec_outcome>They are one of the most abundant filamicrobiomes in the human intestine . Timepoint: before and after 8 weeks of intervention and control. Method of measurement: In this research, an extraction kit will be used to extract genomic DNA from stool samples. Finally, the V4 region of the bacterial 16S rRNA genes will be subjected to PCR amplification to determine the characteristics of the microbiota. The community composition of each sample and the abundance of OTUs at the levels of phylum, class, order, family, genus and species will be counted. Finally, the ratio of Firmicutes/Bactoroidetes will be determined.</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>The University of Shahid Behshti</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-29</approval_date>
        <contact_name>Research ethics committee of Shahid Beheshti University</contact_name>
        <contact_address>Tehran, Evin, Shahid Shahriari Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
