xml: <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/NCT06018415</url>
    </required_header>
    <id_info>
      <org_study_id>No.XJTU1AF2023LSK-398</org_study_id>
      <nct_id>NCT06018415</nct_id>
    </id_info>
    <brief_title>Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome</brief_title>
    <official_title>Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital Xi'an Jiaotong 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>
        Investigators aim to compare the effects of early and late time-restricted feeding on&#xD;
        overweight adults with metabolic syndrome&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in body weight</measure>
      <time_frame>0-week; 6-week and 12-week</time_frame>
      <description>Body weight is assessed at the research center with the participants without shoes and in light clothing using a digital scale (OMRON MEDICAL Beijing Co., Ltd. HNH-318) to the nearest 0.1 kg.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in abdominal fat area</measure>
      <time_frame>0-week; 6-week and 12-week</time_frame>
      <description>Abdominal fat area is measured using bioelectrical impedance analysis (OMRON MEDICAL Beijing Co., Ltd. DUALSCAN, HDS-2000) to the nearest 1 cm2.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in body composition ( body fat mass)</measure>
      <time_frame>0-week; 6-week and 12-week</time_frame>
      <description>Body composition (body fat mass ) is measured using the direct segmental multifrequency bioelectrical impedance analysis method DSM-BIA (InBody H20) to the nearest 0.1 kg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in body composition (body muscle mass)</measure>
      <time_frame>0-week; 6-week and 12-week</time_frame>
      <description>Body composition ( body muscle mass) is measured using the direct segmental multifrequency bioelectrical impedance analysis method DSM-BIA (InBody H20) to the nearest 0.1 kg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in glycemic control, haemoglobin A1c (HbA1c)</measure>
      <time_frame>0-week; 6-week and 12-week</time_frame>
      <description>HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c)</measure>
      <time_frame>0-week; 6-week and 12-week</time_frame>
      <description>Plasma lipids of total cholesterol, TG, HDL-c, and LDL-c are measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 0.01 mmol/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in uric acid (UA)</measure>
      <time_frame>0-week; 6-week and 12-week</time_frame>
      <description>UA is measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 1 µmol/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in blood pressure.</measure>
      <time_frame>0-week; 6-week and 12-week</time_frame>
      <description>Blood pressure is measured in triplicate using a digital automatic blood pressure (Omron HBP-9020, Kyoto, Japan) to the nearest 1 mmHg.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Metabolic Syndrome</condition>
    <condition>Overweight and Obesity</condition>
    <condition>Time Restricted Eating</condition>
    <arm_group>
      <arm_group_label>Early time-restricted eating (eTRE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The eTRE group is instructed to consume all calories from 7 AM to 3 PM each day and fast from 3 PM to 7 AM</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Late time-restricted eating (lTRE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The lTRE group is instructed toconsume all calories from 11 AM to 7 PM each day and fast from 7 PM to 11 PM</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Early time-restricted eating (eTRE)</intervention_name>
      <description>The eTRE group is instructed to consume all calories in early 8h eating window,</description>
      <arm_group_label>Early time-restricted eating (eTRE)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Late time-restricted eating (lTRE)</intervention_name>
      <description>The lTRE group is instructed to consume all calories in late 8h eating window.</description>
      <arm_group_label>Late time-restricted eating (lTRE)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age from 18 to 65 years&#xD;
  &#xD;
            2. Body mass index (BMI): 24.0-40.0 kg/m2&#xD;
  &#xD;
            3. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):&#xD;
  &#xD;
                 1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).&#xD;
  &#xD;
                 2. Elevated triglyceride (TG) (use of medications for elevated TG is an alternate&#xD;
                    indicator) ≥ 150 mg/dL (1.7 mmol/L).&#xD;
  &#xD;
                 3. Reduced high-density lipoprotein cholesterol (HDL-c) (use of medications for&#xD;
                    reduced HDL-c is an alternate indicator) &lt; 40 mg/dL (1.0 mmol/L) in males &lt; 50&#xD;
                    mg/dL (1.3 mmol/L) in females.&#xD;
  &#xD;
                 4. Elevated blood pressure (use of hypoglycemic medications is an alternate&#xD;
                    indicator). Systolic blood pressure (SBP) ≥ 130 and/or diastolic blood pressure&#xD;
                    (DBP) ≥ 85 mmHg.&#xD;
  &#xD;
                 5. Elevated fasting blood glucose (FBG) (used of hypoglycemic medications is an&#xD;
                    alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unstable weight (change &gt; 10% current body weight) for 3 months prior to the study&#xD;
  &#xD;
            2. Pregnant or breast-feeding&#xD;
  &#xD;
            3. Night shift workers&#xD;
  &#xD;
            4. History of major diseases or related diseases, such as cancer, inflammatory disease,&#xD;
               chronic obstructive pulmonary disease and major adverse cardiovascular event&#xD;
  &#xD;
            5. Active viral hepatitis, acquired immune deficiency syndrome, syphilis and other&#xD;
               sexually transmitted diseases, tuberculosis and other infectious diseases&#xD;
  &#xD;
            6. Being treated with antibiotics or corticosteroids&#xD;
  &#xD;
            7. Current participate in other weight-management program, current on a prescribed diet&#xD;
               for special disease or current on any drugs that effect appetite&#xD;
  &#xD;
            8. The researcher deemed it inappropriate to participate in the experimenter.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bingyin Shi</last_name>
      <role>Study Chair</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bingyin Shi</last_name>
      <phone>0086-13630215630</phone>
      <email>sby19590504@126.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Overweight</mesh_term>
      <mesh_term>Metabolic Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018415
  org study id: No.XJTU1AF2023LSK-398
  nct id: NCT06018415
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigators aim to compare the effects of early and late time-restricted feeding on
        overweight adults with metabolic syndrome
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Changes in body weight
  time frame: 0-week; 6-week and 12-week
  description: Body weight is assessed at the research center with the participants without shoes and in light clothing using a digital scale (OMRON MEDICAL Beijing Co., Ltd. HNH-318) to the nearest 0.1 kg.
  measure: Changes in abdominal fat area
  time frame: 0-week; 6-week and 12-week
  description: Abdominal fat area is measured using bioelectrical impedance analysis (OMRON MEDICAL Beijing Co., Ltd. DUALSCAN, HDS-2000) to the nearest 1 cm2.
  measure: Changes in body composition ( body fat mass)
  time frame: 0-week; 6-week and 12-week
  description: Body composition (body fat mass ) is measured using the direct segmental multifrequency bioelectrical impedance analysis method DSM-BIA (InBody H20) to the nearest 0.1 kg.
  measure: Changes in body composition (body muscle mass)
  time frame: 0-week; 6-week and 12-week
  description: Body composition ( body muscle mass) is measured using the direct segmental multifrequency bioelectrical impedance analysis method DSM-BIA (InBody H20) to the nearest 0.1 kg.
  measure: Changes in glycemic control, haemoglobin A1c (HbA1c)
  time frame: 0-week; 6-week and 12-week
  description: HbA1c is measured on an automatic HbA1c analyzer (TOSOH BIOSCIENCE, Inc.; HLC-723G8) to the nearest 0.1%.
  measure: Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c)
  time frame: 0-week; 6-week and 12-week
  description: Plasma lipids of total cholesterol, TG, HDL-c, and LDL-c are measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 0.01 mmol/L.
  measure: Changes in uric acid (UA)
  time frame: 0-week; 6-week and 12-week
  description: UA is measured on an automatic biochemistry analyzer (HITACHI, Inc.; LAbOSPECT, 008AS) using standard reagents to the nearest 1 µmol/L.
  measure: Changes in blood pressure.
  time frame: 0-week; 6-week and 12-week
  description: Blood pressure is measured in triplicate using a digital automatic blood pressure (Omron HBP-9020, Kyoto, Japan) to the nearest 1 mmHg.
  arm group label: Early time-restricted eating (eTRE)
  arm group type: Experimental
  description: The eTRE group is instructed to consume all calories from 7 AM to 3 PM each day and fast from 3 PM to 7 AM
  arm group label: Late time-restricted eating (lTRE)
  arm group type: Experimental
  description: The lTRE group is instructed toconsume all calories from 11 AM to 7 PM each day and fast from 7 PM to 11 PM
  intervention type: Behavioral
  intervention name: Early time-restricted eating (eTRE)
  description: The eTRE group is instructed to consume all calories in early 8h eating window,
  arm group label: Early time-restricted eating (eTRE)
  intervention type: Behavioral
  intervention name: Late time-restricted eating (lTRE)
  description: The lTRE group is instructed to consume all calories in late 8h eating window.
  arm group label: Late time-restricted eating (lTRE)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Bingyin Shi
  role: Study Chair
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Bingyin Shi
  phone: 0086-13630215630
  email: sby19590504@126.com
  responsible party type: Sponsor
  mesh term: Overweight
  mesh term: Metabolic Syndrome
  mesh term: Syndrome
  sharing ipd: No
  ipd description: There is no plan to make individual participant data (IPD) available to other researchers.