<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/NCT04503005</url>
  </required_header>
  <id_info>
    <org_study_id>FaTE-TRE</org_study_id>
    <nct_id>NCT04503005</nct_id>
  </id_info>
  <brief_title>Fasting Time Effects in Time-Restricted Eating (FaTE-TRE)</brief_title>
  <acronym>FaTE-TRE</acronym>
  <official_title>Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Over the past century, lifestyles and eating habits have rapidly changed, helping to increase&#xD;
      the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular&#xD;
      and metabolic diseases such as diabetes.&#xD;
&#xD;
      Recently, dietary regimens such as calorie restriction and intermittent fasting have been&#xD;
      promoted as new strategies for reducing obesity and related co-morbidities. These strategies&#xD;
      have proven effective in reducing body fat, improving blood pressure, lipid profile and&#xD;
      insulin resistance in overweight individuals. However, due to the rigidity of these food&#xD;
      protocols, the adherence of subjects to the diet is often limited or maintained only for&#xD;
      short periods.&#xD;
&#xD;
      Time-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the&#xD;
      subject's daily calorie intake is consumed only in a certain period of time during the day&#xD;
      (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg&#xD;
      IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin,&#xD;
      HDL, TG).&#xD;
&#xD;
      The literature offers numerous versions of intermittent fasting, and the role of fasting&#xD;
      duration is not yet fully clear. Thus. the aim of the present study is to investigate the&#xD;
      effect od different duration of fasting in a TRE protocol on body composition and lipid and&#xD;
      inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on&#xD;
      long term maintenance of diet habits, body composition, lipid and inflammatory profile.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 8, 2021</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>2 months</time_frame>
    <description>change of body fat percentage measured via DEXA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood cholesterol (total, HDL, LDL)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in blood lipid profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood cytokines (IL-6; IL-1, TNF-a)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in blood inflammatory markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morningness-Eveningness Questionnaire (MEQ) on chronotype</measure>
    <time_frame>6 month</time_frame>
    <description>effect od diet in eating behaviours. Minimum value is 16, maximum value is 86 Morningness-Eveningness Questionnaire (MEQ) scale is 0-41, evening type; 42-58 Neither-type; 58-68 Morning-type</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Healthy Diet</condition>
  <condition>Fasting, Intermittent</condition>
  <arm_group>
    <arm_group_label>Effect of fasting duration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>study the effect of different daily fasting duration on body composition and blood lipid and inflammatory markers in healthy adults.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Effect of time restricted eating protocol on chronotype</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>study the effect of 2 month of time restricted eating on the chronotype profile of healthy adults.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Time Restricted Eating</intervention_name>
    <description>Effect of 16, 14 or 12 hours of daily fasting</description>
    <arm_group_label>Effect of fasting duration</arm_group_label>
    <arm_group_label>Effect of time restricted eating protocol on chronotype</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 18-30 kg/m2&#xD;
&#xD;
          -  Stable body weight for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  type 2 Diabetes or pre-diabetes for ADA guidelines&#xD;
&#xD;
          -  Significant Chronic disease&#xD;
&#xD;
          -  recent and acute inflammatory status&#xD;
&#xD;
          -  Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or&#xD;
             estrogen.&#xD;
&#xD;
          -  regular exercise training (≥ 2 sessions/week) or ≥ 10,000 steps/day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatiana Moro, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tatiana Moro, Ph.D</last_name>
    <phone>0498275306</phone>
    <email>tatiana.moro@unipd.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nutrition and Exercise Lab, DSB, University of Padova</name>
      <address>
        <city>Padova</city>
        <zip>35131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tatiana Moro, PhD</last_name>
      <phone>0498275306</phone>
      <email>tatiana.moro@unipd.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 22, 2021</last_update_submitted>
  <last_update_submitted_qc>April 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Padova</investigator_affiliation>
    <investigator_full_name>Antonio Paoli</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>time restricted eating</keyword>
  <keyword>intermitted fasting</keyword>
  <keyword>body composition</keyword>
  <keyword>metabolism</keyword>
  <keyword>inflammation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </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/NCT04503005
org study id: FaTE-TRE
nct id: NCT04503005
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Over the past century, lifestyles and eating habits have rapidly changed, helping to increase
      the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular
      and metabolic diseases such as diabetes.

      Recently, dietary regimens such as calorie restriction and intermittent fasting have been
      promoted as new strategies for reducing obesity and related co-morbidities. These strategies
      have proven effective in reducing body fat, improving blood pressure, lipid profile and
      insulin resistance in overweight individuals. However, due to the rigidity of these food
      protocols, the adherence of subjects to the diet is often limited or maintained only for
      short periods.

      Time-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the
      subject's daily calorie intake is consumed only in a certain period of time during the day
      (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg
      IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin,
      HDL, TG).

      The literature offers numerous versions of intermittent fasting, and the role of fasting
      duration is not yet fully clear. Thus. the aim of the present study is to investigate the
      effect od different duration of fasting in a TRE protocol on body composition and lipid and
      inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on
      long term maintenance of diet habits, body composition, lipid and inflammatory profile.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Body composition
time frame: 2 months
description: change of body fat percentage measured via DEXA
measure: Blood cholesterol (total, HDL, LDL)
time frame: 2 months
description: Change in blood lipid profile
measure: Blood cytokines (IL-6; IL-1, TNF-a)
time frame: 2 months
description: Change in blood inflammatory markers
measure: Morningness-Eveningness Questionnaire (MEQ) on chronotype
time frame: 6 month
description: effect od diet in eating behaviours. Minimum value is 16, maximum value is 86 Morningness-Eveningness Questionnaire (MEQ) scale is 0-41, evening type; 42-58 Neither-type; 58-68 Morning-type
arm group label: Effect of fasting duration
arm group type: Active Comparator
description: study the effect of different daily fasting duration on body composition and blood lipid and inflammatory markers in healthy adults.
arm group label: Effect of time restricted eating protocol on chronotype
arm group type: Other
description: study the effect of 2 month of time restricted eating on the chronotype profile of healthy adults.
intervention type: Other
intervention name: Time Restricted Eating
description: Effect of 16, 14 or 12 hours of daily fasting
arm group label: Effect of fasting duration
arm group label: Effect of time restricted eating protocol on chronotype
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tatiana Moro, Ph.D
role: Principal Investigator
affiliation: University of Padova
last name: Tatiana Moro, Ph.D
phone: 0498275306
email: tatiana.moro@unipd.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Padova
investigator full name: Antonio Paoli
investigator title: Full Professor
sharing ipd: No
ipd description: There is not a plan to make IPD available.