<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/NCT02253056</url>
  </required_header>
  <id_info>
    <org_study_id>MIFT-Trial</org_study_id>
    <nct_id>NCT02253056</nct_id>
  </id_info>
  <brief_title>Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting</brief_title>
  <acronym>MIFT</acronym>
  <official_title>Montag Ist Fasten-Tag (German) - MIFT [Monday is Fasting Day]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Immanuel Hospital, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this pilot study is to evaluate the effects of one regular fasting day per week&#xD;
      over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in the intervention group receive an initial group training for fasting. Then&#xD;
      all participants will observe one fixed fasting day per week (monday) over a total period of&#xD;
      eight weeks.&#xD;
&#xD;
      Participants in the control group receive an initial group training for healthy diet&#xD;
      according to current German guidelines (DGE). Moreover, they will receive the same offer as&#xD;
      in the intervention group at the end of the 8-week study period. Until then the control group&#xD;
      participants follow a regular healthy diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin-like growth factor 1 and brain-derived neurotrophic factor</measure>
    <time_frame>Baseline and after 8 weeks</time_frame>
    <description>Measurement of changes after 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire: WHO-5</measure>
    <time_frame>Baseline, 8 weeks, 6 month</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Profile of mood states questionnaire: POMS</measure>
    <time_frame>Baseline, 8 weeks, 6 month</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression questionnaire: HADS</measure>
    <time_frame>Baseline, 8 weeks, 6 month</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flourishing questionnaire</measure>
    <time_frame>Baseline, 8 weeks, 6 month</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scales and Likert-scales</measure>
    <time_frame>Baseline, 8 weeks, 6 month</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Impedance Analysis (BIA)</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Measurement of changes after 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight and abdominal circumference</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Measurement of changes after 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic bloodpressure</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Measurement of changes after 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Changes after 8 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intermittent fasting over 8 weeks (one day per week)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regular healthy diet according to current German (DGE) guidelines for healthy nutrition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fasting / Caloric Restriction</intervention_name>
    <arm_group_label>Fasting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Diet</intervention_name>
    <arm_group_label>Healthy diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 -65 yrs&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe chronic comorbidity&#xD;
&#xD;
          -  eating disorders&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  planed pregnancy&#xD;
&#xD;
          -  simultaneous participation in other trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Michalsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charité Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Immanuel Hospital Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.naturheilkunde.immanuel.de</url>
    <description>Research Institute´s Homepage</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Andreas Michalsen</investigator_full_name>
    <investigator_title>Prof. Dr. med. Andreas Michalsen</investigator_title>
  </responsible_party>
  <keyword>Fasting</keyword>
  <keyword>Caloric Restriction</keyword>
  <keyword>Focus is to observe effects of fasting in healthy volunteers.</keyword>
  <!-- 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/NCT02253056
org study id: MIFT-Trial
nct id: NCT02253056
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this pilot study is to evaluate the effects of one regular fasting day per week
      over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.
Participants in the intervention group receive an initial group training for fasting. Then
      all participants will observe one fixed fasting day per week (monday) over a total period of
      eight weeks.

      Participants in the control group receive an initial group training for healthy diet
      according to current German guidelines (DGE). Moreover, they will receive the same offer as
      in the intervention group at the end of the 8-week study period. Until then the control group
      participants follow a regular healthy diet.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Insulin-like growth factor 1 and brain-derived neurotrophic factor
time frame: Baseline and after 8 weeks
description: Measurement of changes after 8 weeks
measure: Quality of life questionnaire: WHO-5
time frame: Baseline, 8 weeks, 6 month
description: Questionnaire
measure: Profile of mood states questionnaire: POMS
time frame: Baseline, 8 weeks, 6 month
description: Questionnaire
measure: Anxiety and depression questionnaire: HADS
time frame: Baseline, 8 weeks, 6 month
description: Questionnaire
measure: Flourishing questionnaire
time frame: Baseline, 8 weeks, 6 month
description: Questionnaire
measure: Visual analogue scales and Likert-scales
time frame: Baseline, 8 weeks, 6 month
description: Questionnaire
measure: Body Impedance Analysis (BIA)
time frame: Baseline, 8 weeks
description: Measurement of changes after 8 weeks
measure: Body weight and abdominal circumference
time frame: Baseline, 8 weeks
description: Measurement of changes after 8 weeks
measure: Systolic and diastolic bloodpressure
time frame: Baseline, 8 weeks
description: Measurement of changes after 8 weeks
measure: Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR
time frame: Baseline and 8 weeks
description: Changes after 8 weeks
arm group label: Fasting
arm group type: Experimental
description: Intermittent fasting over 8 weeks (one day per week)
arm group label: Healthy diet
arm group type: Active Comparator
description: Regular healthy diet according to current German (DGE) guidelines for healthy nutrition.
intervention type: Other
intervention name: Fasting / Caloric Restriction
arm group label: Fasting
intervention type: Other
intervention name: Healthy Diet
arm group label: Healthy diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Michalsen, MD
role: Principal Investigator
affiliation: Charité Medical University
facility: 
country: Germany
url: http://www.naturheilkunde.immanuel.de
description: Research Institute´s Homepage
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Andreas Michalsen
investigator title: Prof. Dr. med. Andreas Michalsen