xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981820</url>
    </required_header>
    <id_info>
      <org_study_id>AnkaraUSport</org_study_id>
      <nct_id>NCT05981820</nct_id>
    </id_info>
    <brief_title>High Intensity Interval Training, Creatine Intake and Anaerobic Power</brief_title>
    <official_title>Effect of High Intensity Interval Training and Creatine Intake on Anaerobic Power and Muscle Strength</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Creatine is an ergogenic aid with positive effects on muscle and performance. The aim of the&#xD;
        study was to determine whether there is a difference between the effects of creatine&#xD;
        supplementation taken together with Wingate-based HIIT on anaerobic power, leg strength,&#xD;
        heart rate variability and body composition. In the study, Wingate-based HIIT program was&#xD;
        applied three days a week for six weeks. Anaerobic power (Wingate anaerobic power test),&#xD;
        heart rate variability (Polar H10 chest band), leg strength (back and leg dynamometer) and&#xD;
        body composition (PlusAvis 333) measurements of the participants were made 1 week before the&#xD;
        training program started and the week after the training program ended. Twenty physically&#xD;
        active adult men aged 18-30 were voluntarily included for the study. Participants were&#xD;
        divided into two groups: Wingate-based HIIT with creatine supplementation (K-HIIT) and&#xD;
        Wingate-based HIIT only (HIIT). As a result of the analysis, it was seen that creatine&#xD;
        supplementation taken together with wingate-based HIIT had an effect and increased on the&#xD;
        anaerobic power parameters, peak power, average power and minimum power values, and leg&#xD;
        strength. In addition, it was determined that heart rate variability parameters improved&#xD;
        heart rate (HR, beat/min) and low frequency (LF, ms2) values, but did not cause any change in&#xD;
        body composition. Comparing and investigating the effects of different HIIT methods on&#xD;
        anaerobic power, leg strength, heart rate variability and body composition will increase the&#xD;
        generalizability of the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Despite the time-efficiency of HIIT in inducing chronic physiological adaptation, it depleted&#xD;
        phosphocreatine stores in the muscle and decrease power output. It has been observed that&#xD;
        high-intensity exercise performance increases with the increase of intramuscular&#xD;
        phosphocreatine. It is thought that with creatine supplementation, the rate of&#xD;
        phosphocreatine resynthesis and mitochondrial transfer of ATP to the cytoplasm may increase.&#xD;
        This suggests that performing HIIT with creatine supplementation will provide further&#xD;
        improvement. Therefore, the purpose of this study to compare the effectiveness of HIIT with&#xD;
        creatine supplement compared to HIIT only. We hypothesized that creatine supplementation&#xD;
        intake with wingate-based HIIT will positively affect power capacity and performance-related&#xD;
        parameters.&#xD;
  &#xD;
        The research will be carried out using experimental research design, one of the quantitative&#xD;
        research methods, to measure the variables and determine the relationship between dependent&#xD;
        and independent variables. Anaerobic power, heart rate variability, leg strength, and body&#xD;
        composition measurements of the participants will be made 1 week before the training program&#xD;
        started and the week after the training program ended.&#xD;
  &#xD;
        The G*power software was utilized in order to determine the appropriate sample size. It has&#xD;
        been reported that a minimum of 12 participants, 6 in each group, should be included in the&#xD;
        study (alpha value = 0.05, 1-beta value = 0.80, and effect size = 1.6). Measurement of tests&#xD;
        and the Wingate-based HIIT program will be conducted in the Performance Laboratory of the&#xD;
        Faculty of Sports Sciences of Ankara University. Twenty physically active adult men aged&#xD;
        18-30 years, who had no history of medical and did not use drugs or ergogenic aids, will be&#xD;
        recruited voluntarily. The ethics committee approval for the study methodology was obtained&#xD;
        from the Ethics Committee of Ankara University Rectorate (Number: E-56786525-050.04.04/378028&#xD;
        Decision Number: 2022/02) and it will be carried out in compliance with the Declaration of&#xD;
        Helsinki's principles. Written inform consents which explain the study to the participant and&#xD;
        any right and risk will be obtained prior to data collection. Permission for the research to&#xD;
        be carried out in the Performance Laboratory of the Faculty of Sport Sciences of Ankara&#xD;
        University will be obtained from the Deanery of the Faculty of Sport Sciences of Ankara&#xD;
        University. Participants will be divided into two groups as those who will perform&#xD;
        Wingate-based HIIT with creatine (C-HIIT) (age: 21,78 ± 1,79 years; height: 179.56 ± 8.26 cm;&#xD;
        weight: 76.86 ± 10.66 kg) and those who will perform only Wingate-based HIIT (HIIT) (age:&#xD;
        20.167 ± 0,98 years; height: 172.33 ± 9,88 cm ; weight: 66.53 ± 9.51kg ). Out of twenty&#xD;
        potential participants, only 15 participants agreed to participate in the study (HIIT=6,&#xD;
        C-HIIT=9) and 5 dropped out because of sport injuries that occured before the study process.&#xD;
  &#xD;
        IBM SPSS 24.0 program (SPSS Inc., Chicago, IL, USA) will be used to statistically analyze the&#xD;
        data obtained in the study. First of all, the distribution of the data will be evaluated to&#xD;
        determine the test used to compare the data as parametric or non-parametric. This normality&#xD;
        distribution assessment will be tested with Shapiro Wilk, as both groups had less than 50&#xD;
        participants. Determination of the mean difference in within-group statistics will be&#xD;
        performed with Paired Sample t-Test in data with normal distribution and with Wilcoxon test&#xD;
        in data where it is not normal. Groups will be expressed as mean ± standard error. American&#xD;
        Psychological Association (APA) 6.0 style will be used to report statistical differences. The&#xD;
        alpha value will be accepted as 0.05 in all statistical analysis.&#xD;
  &#xD;
        This study aimed to determine whether there was a difference in the effects of taking&#xD;
        creatine supplementation with Wingate-based HIIT on anaerobic power, leg strength, heart rate&#xD;
        variability and body composition.&#xD;
  &#xD;
        The limitation of the current research is that the study will be carried out with a single&#xD;
        gender. In future studies on the subject, the number of participants can be increased, female&#xD;
        participants can be included in the research and it can be examined whether there is a&#xD;
        difference between genders and to increase the generalizability of the study, the effects of&#xD;
        different HIIT methods on anaerobic power, leg strength, heart rate variability and body&#xD;
        composition can be compared by investigating. In addition, the trial period may be extended&#xD;
        as longer periods are needed to see clearer changes in HRV.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 10, 2022</start_date>
    <completion_date type="Actual">January 15, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wingate anaerobic power test</measure>
      <time_frame>two months</time_frame>
      <description>The Wingate anaerobic power test will be performed using a bicycle ergometer.First, a four-minute warm-up protocol with a bicycle ergometer at 60-80 rpm pedal speed and 50 W workload will be applied. Weights of 7.5% kilograms of their body weight for each participant will be placed on the pan of the bicycle ergometer and anaerobic power testing will be initiated. When they reach the pedal speed to 150 rpm, the test will start. Their maximal effort during 30-seconds will be collected. The Wingate software will be used in which the program set up with the ergometers. Information about the relevant power parameters during the test will be transmitted to the software program on the computer. All power parameters such as both absolute and relative peak power, minimum power, average power etc. will be calculated by the software program automatically.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Leg strength</measure>
      <time_frame>two months</time_frame>
      <description>Back and leg dynamometer (Takei-Back &amp; Lift, Japan) will be used to measure leg strength. Participants will be placed their feet on the dynamometer stand. The legs will be bent at 15 angles, the body slightly forward, and the back straight. The participants will pull the dynamometer bar, which they grasped with their hands, using only their legs, without changing their current position, until the knees will be extended. Participants will repeat this trial twice, and the best value for each participant will be recorded.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">15</enrollment>
    <condition>Creatine</condition>
    <condition>High Intensity Interval Training</condition>
    <arm_group>
      <arm_group_label>HIIT group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will only participate Wingate-based HIIT training.&#xD;
  In the first three weeks:&#xD;
  Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes&#xD;
  Wingate-based HIIT: HIIT 4 sets of 12x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set&#xD;
  Cool-down: 4 minutes of passive rest between sets&#xD;
  In the last three weeks:&#xD;
  Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes&#xD;
  Wingate-based HIIT: HIIT 5 sets of 20x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set Cool-down: 4 minutes of passive rest between sets</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HIIT + creatine group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The HIIT + creatine group will participate the same Wingate-based HIIT training in addition to consume 10 g of creatine supplementation. Participants in this group will use 10 g of creatine monohydrate by dissolved in 200 ml of water. Creatine supplementation will be taken in two doses of five grams, 30 minutes before and after training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Creatine</intervention_name>
      <description>To observe the effects of creatine in the study, 10 g of creatine supplementation was taken only on training days during the study period. Participants used 10 g of creatine monohydrate by dissolved in 200 ml of water. Creatine supplementation was taken in two doses of five grams, 30 minutes before and after training.</description>
      <arm_group_label>HIIT + creatine group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>HIIT training</intervention_name>
      <description>In the first three weeks:&#xD;
  Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes Wingate-based HIIT: HIIT 4 sets of 12x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set Cool-down: 4 minutes of passive rest between sets&#xD;
  In the last three weeks:&#xD;
  Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes Wingate-based HIIT: HIIT 5 sets of 20x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set Cool-down: 4 minutes of passive rest between sets</description>
      <arm_group_label>HIIT + creatine group</arm_group_label>
      <arm_group_label>HIIT group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  having no health and communication problem&#xD;
  &#xD;
            -  using no drugs or ergogenic aids&#xD;
  &#xD;
            -  being physically active adult men aged 18-30 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  using any drugs or ergogenic aids&#xD;
  &#xD;
            -  having any musculoskeletal problem&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dicle Aras</last_name>
      <role>Study Director</role>
      <affiliation>Ankara University Faculty of Sport Sciences</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ankara University Spor Bilimleri Fakultesi</name>
        <address>
          <city>Golbasi</city>
          <state>Ankara</state>
          <zip>06830</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara University</investigator_affiliation>
      <investigator_full_name>Dicle Aras</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <keyword>ergogenic aids</keyword>
    <keyword>HIIT</keyword>
    <keyword>creatine</keyword>
    <keyword>performance</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981820
  org study id: AnkaraUSport
  nct id: NCT05981820
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Creatine is an ergogenic aid with positive effects on muscle and performance. The aim of the
        study was to determine whether there is a difference between the effects of creatine
        supplementation taken together with Wingate-based HIIT on anaerobic power, leg strength,
        heart rate variability and body composition. In the study, Wingate-based HIIT program was
        applied three days a week for six weeks. Anaerobic power (Wingate anaerobic power test),
        heart rate variability (Polar H10 chest band), leg strength (back and leg dynamometer) and
        body composition (PlusAvis 333) measurements of the participants were made 1 week before the
        training program started and the week after the training program ended. Twenty physically
        active adult men aged 18-30 were voluntarily included for the study. Participants were
        divided into two groups: Wingate-based HIIT with creatine supplementation (K-HIIT) and
        Wingate-based HIIT only (HIIT). As a result of the analysis, it was seen that creatine
        supplementation taken together with wingate-based HIIT had an effect and increased on the
        anaerobic power parameters, peak power, average power and minimum power values, and leg
        strength. In addition, it was determined that heart rate variability parameters improved
        heart rate (HR, beat/min) and low frequency (LF, ms2) values, but did not cause any change in
        body composition. Comparing and investigating the effects of different HIIT methods on
        anaerobic power, leg strength, heart rate variability and body composition will increase the
        generalizability of the study.
  Despite the time-efficiency of HIIT in inducing chronic physiological adaptation, it depleted
        phosphocreatine stores in the muscle and decrease power output. It has been observed that
        high-intensity exercise performance increases with the increase of intramuscular
        phosphocreatine. It is thought that with creatine supplementation, the rate of
        phosphocreatine resynthesis and mitochondrial transfer of ATP to the cytoplasm may increase.
        This suggests that performing HIIT with creatine supplementation will provide further
        improvement. Therefore, the purpose of this study to compare the effectiveness of HIIT with
        creatine supplement compared to HIIT only. We hypothesized that creatine supplementation
        intake with wingate-based HIIT will positively affect power capacity and performance-related
        parameters.
  
        The research will be carried out using experimental research design, one of the quantitative
        research methods, to measure the variables and determine the relationship between dependent
        and independent variables. Anaerobic power, heart rate variability, leg strength, and body
        composition measurements of the participants will be made 1 week before the training program
        started and the week after the training program ended.
  
        The G*power software was utilized in order to determine the appropriate sample size. It has
        been reported that a minimum of 12 participants, 6 in each group, should be included in the
        study (alpha value = 0.05, 1-beta value = 0.80, and effect size = 1.6). Measurement of tests
        and the Wingate-based HIIT program will be conducted in the Performance Laboratory of the
        Faculty of Sports Sciences of Ankara University. Twenty physically active adult men aged
        18-30 years, who had no history of medical and did not use drugs or ergogenic aids, will be
        recruited voluntarily. The ethics committee approval for the study methodology was obtained
        from the Ethics Committee of Ankara University Rectorate (Number: E-56786525-050.04.04/378028
        Decision Number: 2022/02) and it will be carried out in compliance with the Declaration of
        Helsinki's principles. Written inform consents which explain the study to the participant and
        any right and risk will be obtained prior to data collection. Permission for the research to
        be carried out in the Performance Laboratory of the Faculty of Sport Sciences of Ankara
        University will be obtained from the Deanery of the Faculty of Sport Sciences of Ankara
        University. Participants will be divided into two groups as those who will perform
        Wingate-based HIIT with creatine (C-HIIT) (age: 21,78 ± 1,79 years; height: 179.56 ± 8.26 cm;
        weight: 76.86 ± 10.66 kg) and those who will perform only Wingate-based HIIT (HIIT) (age:
        20.167 ± 0,98 years; height: 172.33 ± 9,88 cm ; weight: 66.53 ± 9.51kg ). Out of twenty
        potential participants, only 15 participants agreed to participate in the study (HIIT=6,
        C-HIIT=9) and 5 dropped out because of sport injuries that occured before the study process.
  
        IBM SPSS 24.0 program (SPSS Inc., Chicago, IL, USA) will be used to statistically analyze the
        data obtained in the study. First of all, the distribution of the data will be evaluated to
        determine the test used to compare the data as parametric or non-parametric. This normality
        distribution assessment will be tested with Shapiro Wilk, as both groups had less than 50
        participants. Determination of the mean difference in within-group statistics will be
        performed with Paired Sample t-Test in data with normal distribution and with Wilcoxon test
        in data where it is not normal. Groups will be expressed as mean ± standard error. American
        Psychological Association (APA) 6.0 style will be used to report statistical differences. The
        alpha value will be accepted as 0.05 in all statistical analysis.
  
        This study aimed to determine whether there was a difference in the effects of taking
        creatine supplementation with Wingate-based HIIT on anaerobic power, leg strength, heart rate
        variability and body composition.
  
        The limitation of the current research is that the study will be carried out with a single
        gender. In future studies on the subject, the number of participants can be increased, female
        participants can be included in the research and it can be examined whether there is a
        difference between genders and to increase the generalizability of the study, the effects of
        different HIIT methods on anaerobic power, leg strength, heart rate variability and body
        composition can be compared by investigating. In addition, the trial period may be extended
        as longer periods are needed to see clearer changes in HRV.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Wingate anaerobic power test
  time frame: two months
  description: The Wingate anaerobic power test will be performed using a bicycle ergometer.First, a four-minute warm-up protocol with a bicycle ergometer at 60-80 rpm pedal speed and 50 W workload will be applied. Weights of 7.5% kilograms of their body weight for each participant will be placed on the pan of the bicycle ergometer and anaerobic power testing will be initiated. When they reach the pedal speed to 150 rpm, the test will start. Their maximal effort during 30-seconds will be collected. The Wingate software will be used in which the program set up with the ergometers. Information about the relevant power parameters during the test will be transmitted to the software program on the computer. All power parameters such as both absolute and relative peak power, minimum power, average power etc. will be calculated by the software program automatically.
  measure: Leg strength
  time frame: two months
  description: Back and leg dynamometer (Takei-Back & Lift, Japan) will be used to measure leg strength. Participants will be placed their feet on the dynamometer stand. The legs will be bent at 15 angles, the body slightly forward, and the back straight. The participants will pull the dynamometer bar, which they grasped with their hands, using only their legs, without changing their current position, until the knees will be extended. Participants will repeat this trial twice, and the best value for each participant will be recorded.
  arm group label: HIIT group
  arm group type: Experimental
  description: This group will only participate Wingate-based HIIT training.
  In the first three weeks:
  Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes
  Wingate-based HIIT: HIIT 4 sets of 12x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set
  Cool-down: 4 minutes of passive rest between sets
  In the last three weeks:
  Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes
  Wingate-based HIIT: HIIT 5 sets of 20x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set Cool-down: 4 minutes of passive rest between sets
  arm group label: HIIT + creatine group
  arm group type: Experimental
  description: The HIIT + creatine group will participate the same Wingate-based HIIT training in addition to consume 10 g of creatine supplementation. Participants in this group will use 10 g of creatine monohydrate by dissolved in 200 ml of water. Creatine supplementation will be taken in two doses of five grams, 30 minutes before and after training.
  intervention type: Dietary Supplement
  intervention name: Creatine
  description: To observe the effects of creatine in the study, 10 g of creatine supplementation was taken only on training days during the study period. Participants used 10 g of creatine monohydrate by dissolved in 200 ml of water. Creatine supplementation was taken in two doses of five grams, 30 minutes before and after training.
  arm group label: HIIT + creatine group
  intervention type: Other
  intervention name: HIIT training
  description: In the first three weeks:
  Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes Wingate-based HIIT: HIIT 4 sets of 12x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set Cool-down: 4 minutes of passive rest between sets
  In the last three weeks:
  Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes Wingate-based HIIT: HIIT 5 sets of 20x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set Cool-down: 4 minutes of passive rest between sets
  arm group label: HIIT + creatine group
  arm group label: HIIT group
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dicle Aras
  role: Study Director
  affiliation: Ankara University Faculty of Sport Sciences
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ankara University
  investigator full name: Dicle Aras
  investigator title: Director
  sharing ipd: No