<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/NCT04476615</url>
  </required_header>
  <id_info>
    <org_study_id>140166</org_study_id>
    <nct_id>NCT04476615</nct_id>
  </id_info>
  <brief_title>Effects of Fasting-Mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance</brief_title>
  <acronym>FMD_Exercise</acronym>
  <official_title>Effects of Fasting-mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universita di Verona</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to test a Fasting Mimicking Diet (FMD) for its efficacy on improving&#xD;
      muscular resistance and endurance. The investigators will perform a randomized clinical trial&#xD;
      to test the efficacy of the FMD on improving muscular strength, muscular resistance and&#xD;
      endurance in physically active young adults (18-40 years of age). The study will include two&#xD;
      arms: Placebo (Placebo diet) and FMD (3 cycles of 5-day fasting-mimicking diet within two&#xD;
      months). Study endpoints will include muscular strength evaluation of lower limbs,&#xD;
      cardio-pulmonary responses, neuromuscular function and muscle architecture. Subjects will be&#xD;
      evaluated 4 times within 3 months: at baseline (T1), after the 1st cycle of diet (T2), 7 to&#xD;
      15 days after the 3rd cycle of diet maintaining baseline intensity (T3) and with&#xD;
      re-assessment of Peak Power Output (T4).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">January 16, 2020</completion_date>
  <primary_completion_date type="Actual">January 16, 2020</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in time to exhaustion (TTE)</measure>
    <time_frame>baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Difference between time points in time duration [s] of the exercise at a given power output (85%) and cadence (60 RPM), before the given work rate could not be sustained.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in maximal voluntary contraction (MVC)</measure>
    <time_frame>baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Variation between time points in maximal force voluntarily produced by the knee extensor muscles pre- and immediately post exercise, considering for lever length [N*m].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in voluntary (muscle) activation (VA)</measure>
    <time_frame>baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Change between time points in the percentage of muscle activated by volition. [%] To quantify voluntary activation, the amplitude of the superimposed twitch is expressed as a fraction of the twitch evoked by the same stimulus in the relaxed muscle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in resting twitch force (RT)</measure>
    <time_frame>baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Force elicited at rest by electrical stimulation of the femoral nerve, considering for lever length [N*m].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in oxygen consumption (VO2)</measure>
    <time_frame>baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Variations of mean oxygen consumption at rest and at each minute while exercising (performance test).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in peak (task-specific) oxygen consumption (VO2)</measure>
    <time_frame>baseline (T1) and after 2 months (T4).</time_frame>
    <description>Peak oxygen consumption during the incremental test (maximal value during a 30&quot; time-window).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in femoral (artery) blood flow (FBF)</measure>
    <time_frame>at rest and during the performance test. Differences between each time point will be assessed: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Measurements of common femoral arterial blood velocity (Vmean) and vessel diameter will be performed using ultrasound Doppler, distal to the inguinal ligament and proximal to the bifurcation of the deep and superficial femoral arteries. (FBF = Vmean p (vessel diameter/2)^2 * 60)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in median frequency of the power spectrum density of EMG</measure>
    <time_frame>during the performance test at each time point: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>EMG signal from the vastus lateralis (VL) muscle was recorded throughout exercise to estimate the output of spinal motoneurons and the development of peripheral fatigue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in carbon dioxide (VCO2) production</measure>
    <time_frame>baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Variation of physiological production of CO2 at rest and while exercising measured by a breath-by-breath system [L/min].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in minute ventilation (VE)</measure>
    <time_frame>baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Difference in ventilatory response at rest and while exercising measured by a breath-by-breath system [L/min].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate (HR)</measure>
    <time_frame>baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)</time_frame>
    <description>Difference in the cardiac response at rest and while exercising measured by a heart rate monitor system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Power Output (Wpeak)</measure>
    <time_frame>baseline (T1) and after 2 months (T4).</time_frame>
    <description>Difference in maximal power [Watts] achieved (last completed 1-min step) during the incremental test sessions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Fatigue; Muscle, Heart</condition>
  <condition>Fasting</condition>
  <condition>Diet, Healthy</condition>
  <condition>Fatigue, Mental</condition>
  <arm_group>
    <arm_group_label>FMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fasting-Mimicking diet (ProLon®)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Low-energy bars (L-Nutra®) supplementation</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fasting-Mimicking Diet (ProLon®)</intervention_name>
    <description>Dietary restriction: Fasting-Mimicking Diet (ProLon®). 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).</description>
    <arm_group_label>FMD</arm_group_label>
    <other_name>Dieta Mima Digiuno® (italian name)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo bars</intervention_name>
    <description>Dietary supplementation: Low-energy bars (L-Nutra®) to integrate the daily nutritional habits - one bar per day.&#xD;
5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male sex;&#xD;
&#xD;
          -  Age Range: 18-40 years old;&#xD;
&#xD;
          -  Body Mass Index (BMI) range between 18.5 and 30;&#xD;
&#xD;
          -  METs minutes per week - calculated by International physical activity questionnaire&#xD;
             (IPAQ) - between 600 and 3000.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female sex;&#xD;
&#xD;
          -  History of muscle, joints and nerves injuries to the upper and/or lower limbs in the&#xD;
             previous 12 months;&#xD;
&#xD;
          -  Body Mass Index (BMI) below 18.5 and above 30;&#xD;
&#xD;
          -  METs minutes per week - calculated by International physical activity questionnaire&#xD;
             (IPAQ) - below 600 or above 3000.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matteo Bertucco, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurosciences, Biomedicine and Movement Sciences - University of Verona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurosciences, Biomedicine and Movement Sciences</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita di Verona</investigator_affiliation>
    <investigator_full_name>Matteo Bertucco</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>fatigue</keyword>
  <keyword>fasting-mimicking diet</keyword>
  <keyword>healthy</keyword>
  <keyword>young adults</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Mental Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available upon request to the corresponding author after publication of the original article.</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT04476615
org study id: 140166
nct id: NCT04476615
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The aim of the study is to test a Fasting Mimicking Diet (FMD) for its efficacy on improving
      muscular resistance and endurance. The investigators will perform a randomized clinical trial
      to test the efficacy of the FMD on improving muscular strength, muscular resistance and
      endurance in physically active young adults (18-40 years of age). The study will include two
      arms: Placebo (Placebo diet) and FMD (3 cycles of 5-day fasting-mimicking diet within two
      months). Study endpoints will include muscular strength evaluation of lower limbs,
      cardio-pulmonary responses, neuromuscular function and muscle architecture. Subjects will be
      evaluated 4 times within 3 months: at baseline (T1), after the 1st cycle of diet (T2), 7 to
      15 days after the 3rd cycle of diet maintaining baseline intensity (T3) and with
      re-assessment of Peak Power Output (T4).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Difference in time to exhaustion (TTE)
time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Difference between time points in time duration [s] of the exercise at a given power output (85%) and cadence (60 RPM), before the given work rate could not be sustained.
measure: Change in maximal voluntary contraction (MVC)
time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Variation between time points in maximal force voluntarily produced by the knee extensor muscles pre- and immediately post exercise, considering for lever length [N*m].
measure: Change in voluntary (muscle) activation (VA)
time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Change between time points in the percentage of muscle activated by volition. [%] To quantify voluntary activation, the amplitude of the superimposed twitch is expressed as a fraction of the twitch evoked by the same stimulus in the relaxed muscle.
measure: Change in resting twitch force (RT)
time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Force elicited at rest by electrical stimulation of the femoral nerve, considering for lever length [N*m].
measure: Change in oxygen consumption (VO2)
time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Variations of mean oxygen consumption at rest and at each minute while exercising (performance test).
measure: Change in peak (task-specific) oxygen consumption (VO2)
time frame: baseline (T1) and after 2 months (T4).
description: Peak oxygen consumption during the incremental test (maximal value during a 30" time-window).
measure: Change in femoral (artery) blood flow (FBF)
time frame: at rest and during the performance test. Differences between each time point will be assessed: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Measurements of common femoral arterial blood velocity (Vmean) and vessel diameter will be performed using ultrasound Doppler, distal to the inguinal ligament and proximal to the bifurcation of the deep and superficial femoral arteries. (FBF = Vmean p (vessel diameter/2)^2 * 60)
measure: Change in median frequency of the power spectrum density of EMG
time frame: during the performance test at each time point: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: EMG signal from the vastus lateralis (VL) muscle was recorded throughout exercise to estimate the output of spinal motoneurons and the development of peripheral fatigue.
measure: Change in carbon dioxide (VCO2) production
time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Variation of physiological production of CO2 at rest and while exercising measured by a breath-by-breath system [L/min].
measure: Change in minute ventilation (VE)
time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Difference in ventilatory response at rest and while exercising measured by a breath-by-breath system [L/min].
measure: Change in heart rate (HR)
time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
description: Difference in the cardiac response at rest and while exercising measured by a heart rate monitor system.
measure: Change in Peak Power Output (Wpeak)
time frame: baseline (T1) and after 2 months (T4).
description: Difference in maximal power [Watts] achieved (last completed 1-min step) during the incremental test sessions.
arm group label: FMD
arm group type: Experimental
description: Fasting-Mimicking diet (ProLon®)
arm group label: Placebo
arm group type: Placebo Comparator
description: Low-energy bars (L-Nutra®) supplementation
intervention type: Dietary Supplement
intervention name: Fasting-Mimicking Diet (ProLon®)
description: Dietary restriction: Fasting-Mimicking Diet (ProLon®). 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).
arm group label: FMD
other name: Dieta Mima Digiuno® (italian name)
intervention type: Dietary Supplement
intervention name: Placebo bars
description: Dietary supplementation: Low-energy bars (L-Nutra®) to integrate the daily nutritional habits - one bar per day.
5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matteo Bertucco, PhD
role: Principal Investigator
affiliation: Department of Neurosciences, Biomedicine and Movement Sciences - University of Verona
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Universita di Verona
investigator full name: Matteo Bertucco
investigator title: Associate Professor
mesh term: Fatigue
mesh term: Mental Fatigue
sharing ipd: Yes
ipd description: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
ipd info type: Study Protocol
ipd time frame: Data will be available upon request to the corresponding author after publication of the original article.