<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/NCT03786523</url>
  </required_header>
  <id_info>
    <org_study_id>NFEC-2018-160</org_study_id>
    <nct_id>NCT03786523</nct_id>
  </id_info>
  <brief_title>Time Restricted Feeding on Nonalcoholic Fatty Liver Disease</brief_title>
  <acronym>TREATY-FLD</acronym>
  <official_title>Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</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>
      Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that&#xD;
      involves eating a daily period of 8 hours or less. This is a randomized controlled trial to&#xD;
      evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and&#xD;
      cardiometabolic risk factors in obese adults over 6 months compared to continuous energy&#xD;
      restriction (CER).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2019</start_date>
  <completion_date type="Actual">February 10, 2021</completion_date>
  <primary_completion_date type="Actual">January 28, 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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in intrahepatic fat content</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>Intrahepatic fat content will be assessed by MR mDixon-Quant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in liver fiber</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>Liver fiber will be assessed by liver Fibrotouch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in visceral fat</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>Visceral fat will be assessed by abdominal CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body fat</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>Body fat will be assessed by whole-body dual x-ray system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>Baseline and months 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Baseline and months 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c level</measure>
    <time_frame>Baseline and months 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic blood pressure</measure>
    <time_frame>Baseline and months 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL-c level</measure>
    <time_frame>Baseline and months 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum ALT level</measure>
    <time_frame>Baseline and months 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin sensitivity</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>Insulin sensitivity will be assessed by HOMA-IR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in β cell function</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>β cell function will be assessed by HOMA-β</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulse wave velocity (PWV)</measure>
    <time_frame>Baseline and months 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression measured by the Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>Scores of PHQ-9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>Scores of PSQI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)</measure>
    <time_frame>Baseline and months 6</time_frame>
    <description>Scores of SF-12</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Nonalcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>TRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time Restricted Feeding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CER</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous Energy Restriction</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time restricted feeding</intervention_name>
    <description>Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).</description>
    <arm_group_label>TRF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Continuous Energy Restriction</intervention_name>
    <description>Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on feeding time.</description>
    <arm_group_label>CER</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Man or women aged≥18 years;&#xD;
&#xD;
          2. Subjects with NAFLD determined by MRI (intrahepatic triglyceride content ≥5%);&#xD;
&#xD;
          3. Body mass index (BMI)of 28.0 to 45.0 kg/m2;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis,&#xD;
             autoimmune hepatitis, cirrhosis, and liver cancer;&#xD;
&#xD;
          2. History of HIV, or active pulmonary tuberculosis;&#xD;
&#xD;
          3. Diagnosis of type 1 and type 2 diabetes;&#xD;
&#xD;
          4. History of malignant tumors;&#xD;
&#xD;
          5. Serious liver dysfunction or chronic kidney disease (AST or ALT &gt; 3 times the upper&#xD;
             limit of normal, or eGFR&lt;30 ml/min/1.73 m2);&#xD;
&#xD;
          6. Significant alcohol consumption in the past six months (Consumed more than 20 g/day&#xD;
             for women or 30 g/day for men);&#xD;
&#xD;
          7. History of serious cardiovascular or cerebrovascular disease (angina, myocardial&#xD;
             infarction or stroke) in the past 6 months;&#xD;
&#xD;
          8. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12&#xD;
             months;&#xD;
&#xD;
          9. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;&#xD;
&#xD;
         10. Being a smoker or having been a smoker in the 3 months prior to their screening visit;&#xD;
&#xD;
         11. Taking medications affecting weight or energy intake/energy expenditure in the last 6&#xD;
             months, including weight loss medications, antipsychotic drugs or other medications as&#xD;
             determined by the study physician;&#xD;
&#xD;
         12. Currently participating in weight loss programs or weight change in the past 3 months&#xD;
             (&gt; 5% current body weight) ;&#xD;
&#xD;
         13. Women who are pregnant or plan to become pregnant;&#xD;
&#xD;
         14. Patients who cannot be followed for 24 months (due to a health situation or&#xD;
             migration);&#xD;
&#xD;
         15. Patients who are unwilling or unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huijie Zhang, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>July 31, 2021</last_update_submitted>
  <last_update_submitted_qc>July 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Huijie Zhang</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <keyword>Nonalcoholic Fatty Liver Disease</keyword>
  <keyword>Obesity</keyword>
  <keyword>Time restricted feeding</keyword>
  <keyword>Calorie restriction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03786523
org study id: NFEC-2018-160
nct id: NCT03786523
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that
      involves eating a daily period of 8 hours or less. This is a randomized controlled trial to
      evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and
      cardiometabolic risk factors in obese adults over 6 months compared to continuous energy
      restriction (CER).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in intrahepatic fat content
time frame: Baseline and months 6
description: Intrahepatic fat content will be assessed by MR mDixon-Quant
measure: Change in liver fiber
time frame: Baseline and months 6
description: Liver fiber will be assessed by liver Fibrotouch
measure: Change in visceral fat
time frame: Baseline and months 6
description: Visceral fat will be assessed by abdominal CT scan
measure: Change in body fat
time frame: Baseline and months 6
description: Body fat will be assessed by whole-body dual x-ray system
measure: Change in waist circumference
time frame: Baseline and months 6
measure: Change in body weight
time frame: Baseline and months 6
measure: Change in HbA1c level
time frame: Baseline and months 6
measure: Change in Systolic blood pressure
time frame: Baseline and months 6
measure: Change in LDL-c level
time frame: Baseline and months 6
measure: Change in serum ALT level
time frame: Baseline and months 6
measure: Change in insulin sensitivity
time frame: Baseline and months 6
description: Insulin sensitivity will be assessed by HOMA-IR
measure: Change in β cell function
time frame: Baseline and months 6
description: β cell function will be assessed by HOMA-β
measure: Change in pulse wave velocity (PWV)
time frame: Baseline and months 6
measure: Depression measured by the Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline and months 6
description: Scores of PHQ-9
measure: Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)
time frame: Baseline and months 6
description: Scores of PSQI
measure: Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
time frame: Baseline and months 6
description: Scores of SF-12
arm group label: TRF
arm group type: Experimental
description: Time Restricted Feeding
arm group label: CER
arm group type: Active Comparator
description: Continuous Energy Restriction
intervention type: Behavioral
intervention name: Time restricted feeding
description: Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).
arm group label: TRF
intervention type: Behavioral
intervention name: Continuous Energy Restriction
description: Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on feeding time.
arm group label: CER
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Huijie Zhang, MD,PhD
role: Study Chair
affiliation: Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Huijie Zhang
investigator title: Clinical professor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No