<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/NCT04452916</url>
  </required_header>
  <id_info>
    <org_study_id>LEANER</org_study_id>
    <nct_id>NCT04452916</nct_id>
  </id_info>
  <brief_title>Physiological Response to 5 Days Fasting</brief_title>
  <official_title>Physiological Response to Prolonged Fasting in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      To investigate energy metabolism, anthropometry, blood pressure, gut microbiome, serum&#xD;
      metabolome, glucose variability and neural mechanisms of food choice and mood before and&#xD;
      after 5 days of fasting as well as their persistence in healthy men and women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">December 14, 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>
    <intervention_model_description>Waiting list control group</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resting Energy Expenditure</measure>
    <time_frame>6-th day of fasting compared to baseline</time_frame>
    <description>Measured by indirect calorimetry (kcal/d)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resting Energy Expenditure - Recovery</measure>
    <time_frame>12 weeks after fasting compared to baseline</time_frame>
    <description>Measured by indirect calorimetry (kcal/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting Respiratory Exchange Ratio</measure>
    <time_frame>6-th day of fasting and 28 days after fasting compared to baseline</time_frame>
    <description>Measured by indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Office systolic blood pressure</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Mean of five consecutive blood pressure measurements (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Office diastolic blood pressure</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Mean of five consecutive blood pressure measurements (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal microbiome composition</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Measured by 16S Sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal and serum metabolome</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Measured by mass spectrometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in immune cell phenotypes</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Peripheral blood effector T cell frequencies (Percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose variability</measure>
    <time_frame>From 3 days before until 6 days after fasting</time_frame>
    <description>Measured by continuous glucose monitoring over 14 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neural correlates of emotion processing</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Measured by functional Magnetic Resonance Imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neural correlates of food-specific delay discounting</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Measured by functional Magnetic Resonance Imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Questionaire (PSQ)</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Range 0-100, with 0 indicating no perceived stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Self Efficiency</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Range 10-40, with 40 indicating highest self efficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PANAS Positive Affect Subscale (GESIS Panel)</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Range 10-50, with 50 indicating highest positive affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PANAS Negative Affect Subscale (GESIS Panel)</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Range 10-50, with 50 indicating highest negative affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionaire (IPAQ, long version)</measure>
    <time_frame>6-th day of fasting and 12 weeks after fasting compared to baseline</time_frame>
    <description>Time for moderate and vigorous activity (hours, minutes)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Fasting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Starts immediately with 5 days of Buchinger fasting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Starts with 5 days of Buchinger fasting after a waiting period of 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Buchinger fasting</intervention_name>
    <description>Caloric intake of &lt; 250 kcal/d for 5 days</description>
    <arm_group_label>Fasting</arm_group_label>
    <arm_group_label>Waiting list control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
          -  20-50 years&#xD;
&#xD;
          -  Body mass index 20-30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant heart, lung, liver, and kidney diseases&#xD;
&#xD;
          -  Any prescribed medication (except for oral contraceptives)&#xD;
&#xD;
          -  Current or chronic infection&#xD;
&#xD;
          -  Intake of antibiotics within 6 months before study entry&#xD;
&#xD;
          -  Fasting week within 6 months before study entry&#xD;
&#xD;
          -  Habitual use of dietary supplements&#xD;
&#xD;
          -  Food intolerances&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Vegan diet&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  In addition for fMRI: sensorineural hearing loss, tinnitus, metal implants, electric&#xD;
             devices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anja Mähler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Anja Maehler</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal.</ipd_access_criteria>
  </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/NCT04452916
org study id: LEANER
nct id: NCT04452916
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate energy metabolism, anthropometry, blood pressure, gut microbiome, serum
      metabolome, glucose variability and neural mechanisms of food choice and mood before and
      after 5 days of fasting as well as their persistence in healthy men and women.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Waiting list control group
primary purpose: Basic Science
masking: None (Open Label)
measure: Resting Energy Expenditure
time frame: 6-th day of fasting compared to baseline
description: Measured by indirect calorimetry (kcal/d)
measure: Resting Energy Expenditure - Recovery
time frame: 12 weeks after fasting compared to baseline
description: Measured by indirect calorimetry (kcal/d)
measure: Resting Respiratory Exchange Ratio
time frame: 6-th day of fasting and 28 days after fasting compared to baseline
description: Measured by indirect calorimetry
measure: Office systolic blood pressure
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Mean of five consecutive blood pressure measurements (mmHg)
measure: Office diastolic blood pressure
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Mean of five consecutive blood pressure measurements (mmHg)
measure: Fecal microbiome composition
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Measured by 16S Sequencing
measure: Fecal and serum metabolome
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Measured by mass spectrometry
measure: Change in immune cell phenotypes
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Peripheral blood effector T cell frequencies (Percent)
measure: Glucose variability
time frame: From 3 days before until 6 days after fasting
description: Measured by continuous glucose monitoring over 14 days
measure: Neural correlates of emotion processing
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Measured by functional Magnetic Resonance Imaging
measure: Neural correlates of food-specific delay discounting
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Measured by functional Magnetic Resonance Imaging
measure: Perceived Stress Questionaire (PSQ)
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Range 0-100, with 0 indicating no perceived stress
measure: Perceived Self Efficiency
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Range 10-40, with 40 indicating highest self efficiency
measure: PANAS Positive Affect Subscale (GESIS Panel)
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Range 10-50, with 50 indicating highest positive affect
measure: PANAS Negative Affect Subscale (GESIS Panel)
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Range 10-50, with 50 indicating highest negative affect
measure: International Physical Activity Questionaire (IPAQ, long version)
time frame: 6-th day of fasting and 12 weeks after fasting compared to baseline
description: Time for moderate and vigorous activity (hours, minutes)
arm group label: Fasting
arm group type: Active Comparator
description: Starts immediately with 5 days of Buchinger fasting
arm group label: Waiting list control
arm group type: Placebo Comparator
description: Starts with 5 days of Buchinger fasting after a waiting period of 12 weeks
intervention type: Other
intervention name: Buchinger fasting
description: Caloric intake of < 250 kcal/d for 5 days
arm group label: Fasting
arm group label: Waiting list control
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anja Mähler, PhD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Anja Maehler
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
ipd info type: Study Protocol
ipd time frame: Beginning 9 months and ending 36 months following article publication.
ipd access criteria: Researchers who provide a methodologically sound proposal.