<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/NCT04404413</url>
  </required_header>
  <id_info>
    <org_study_id>CE061811</org_study_id>
    <nct_id>NCT04404413</nct_id>
  </id_info>
  <brief_title>High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women</brief_title>
  <official_title>Effect of High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alicante</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alicante</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the body composition and physical performance&#xD;
      effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen&#xD;
      active normal weight women aged 18-35 participated in the study. The effects of 2x8 weeks&#xD;
      without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in&#xD;
      weekly energy intake) on body composition and performance (Hand-grip strength, Counter&#xD;
      movement jump, Wingate Anaerobic 30 s Cycling Test), were compared. There were two weeks in&#xD;
      between both phases when they did not perform the scheduled activity, so as not to alter the&#xD;
      experimental phase.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hand-grip strength</measure>
    <time_frame>16 weeks</time_frame>
    <description>Hand-grip strength test was performed as an indicator of overall strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Counter movement jump (CMJ)</measure>
    <time_frame>16 weeks</time_frame>
    <description>In the CMJ test, the participants performed a maximum vertical jump starting from a standing position with arm swing not allowed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wingate Anaerobic 30 s Cycling Test</measure>
    <time_frame>16 weeks</time_frame>
    <description>Wingate Anaerobic 30 s Cycling Test with a validated cycloergometer (Monark 894E, Vansbro, Sweden).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat mass</measure>
    <time_frame>16 weeks</time_frame>
    <description>Body composition masses were estimated using validated equations. Carter's equation was used to estimate fat mass.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle mass</measure>
    <time_frame>16 weeks</time_frame>
    <description>Body composition masses were estimated using validated equations. Lee's equation to estimate muscle mass.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Residual mass</measure>
    <time_frame>16 weeks</time_frame>
    <description>Body composition masses were estimated using validated equations. Residual mass was obtained from the difference between fat mass and muscle mass.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass</measure>
    <time_frame>16 weeks</time_frame>
    <description>It was performed using a digital scale with 0,1kg accuracy (Tanita BC-545, Tokyo, Japan).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Body Composition</condition>
  <condition>Physical Performance</condition>
  <condition>Intermittent Fasting</condition>
  <arm_group>
    <arm_group_label>PARTICIPANTS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single-group crossover design was used to compare the effects of 2x8 weeks of high-intensity interval training without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance. There were two weeks in the middle of both phases in which they did not carry out programmed activity, in order not to alter the experimental phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensity interval training (HIIT)</intervention_name>
    <description>2x8 weeks of high-intensity interval training (HIIT)</description>
    <arm_group_label>PARTICIPANTS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensity interval training (HIIT) + intermittent fasting</intervention_name>
    <description>2x8 high-intensity interval training with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake).</description>
    <arm_group_label>PARTICIPANTS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. No muscular, ligamentous, bone, nerve or joint pathology incompatible with the&#xD;
             training program.&#xD;
&#xD;
          2. Not to present cardiovascular or cardiorespiratory problems.&#xD;
&#xD;
          3. Physically active in the last 5 years, according to the American College of Sports&#xD;
             Medicine (ACSM) definition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Following pharmacological treatment or supplement.&#xD;
&#xD;
          2. Performing other sports activities that may influence the study results during their&#xD;
             participation in the study.&#xD;
&#xD;
          3. Not following training or diet program guidelines or attending scheduled training&#xD;
             sessions.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alejandro Martínez Rodriguez</name>
      <address>
        <city>San Vicente Del Raspeig</city>
        <state>Alicante</state>
        <zip>03690</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alicante</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Alejandro Martínez-Rodríguez</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04404413
org study id: CE061811
nct id: NCT04404413
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to compare the body composition and physical performance
      effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen
      active normal weight women aged 18-35 participated in the study. The effects of 2x8 weeks
      without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in
      weekly energy intake) on body composition and performance (Hand-grip strength, Counter
      movement jump, Wingate Anaerobic 30 s Cycling Test), were compared. There were two weeks in
      between both phases when they did not perform the scheduled activity, so as not to alter the
      experimental phase.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Hand-grip strength
time frame: 16 weeks
description: Hand-grip strength test was performed as an indicator of overall strength.
measure: Counter movement jump (CMJ)
time frame: 16 weeks
description: In the CMJ test, the participants performed a maximum vertical jump starting from a standing position with arm swing not allowed.
measure: Wingate Anaerobic 30 s Cycling Test
time frame: 16 weeks
description: Wingate Anaerobic 30 s Cycling Test with a validated cycloergometer (Monark 894E, Vansbro, Sweden).
measure: Fat mass
time frame: 16 weeks
description: Body composition masses were estimated using validated equations. Carter's equation was used to estimate fat mass.
measure: Muscle mass
time frame: 16 weeks
description: Body composition masses were estimated using validated equations. Lee's equation to estimate muscle mass.
measure: Residual mass
time frame: 16 weeks
description: Body composition masses were estimated using validated equations. Residual mass was obtained from the difference between fat mass and muscle mass.
measure: Body Mass
time frame: 16 weeks
description: It was performed using a digital scale with 0,1kg accuracy (Tanita BC-545, Tokyo, Japan).
arm group label: PARTICIPANTS
arm group type: Experimental
description: A single-group crossover design was used to compare the effects of 2x8 weeks of high-intensity interval training without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance. There were two weeks in the middle of both phases in which they did not carry out programmed activity, in order not to alter the experimental phase.
intervention type: Behavioral
intervention name: Intensity interval training (HIIT)
description: 2x8 weeks of high-intensity interval training (HIIT)
arm group label: PARTICIPANTS
intervention type: Behavioral
intervention name: Intensity interval training (HIIT) + intermittent fasting
description: 2x8 high-intensity interval training with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake).
arm group label: PARTICIPANTS
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alicante
investigator full name: Prof. Dr. Alejandro Martínez-Rodríguez
investigator title: Assistant Professor