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/NCT05964179</url>
    </required_header>
    <id_info>
      <org_study_id>1041078-20230217-BR-035</org_study_id>
      <nct_id>NCT05964179</nct_id>
    </id_info>
    <brief_title>Effects of Daily Eating Duration on Health</brief_title>
    <official_title>Identification of Chrononutrition Factors Associated With Chronic Non-communicable Diseases and Investigation of Circadian Gene-Chrononutrition Interactions in the Development of Chronic Non-communicable Diseases Among Koreans</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chung-Ang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Research Foundation of Korea</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Chung-Ang University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study would recruit about 50 healthy adult women and randomly divide the participants&#xD;
        into two groups for a ten-week crossover intervention study. The investigators aimed to&#xD;
        observe the impact of daily feeding/fasting time on clinical metabolic biomarkers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Many nutritional epidemiological studies conducted among various population groups (Cohort&#xD;
        study, RCT study) found that chrono-nutrition factors such as morning fasting, functional&#xD;
        supplements like fish oils, intermittent fasting, and time-restricted feeding were related to&#xD;
        weight management, cardiovascular metabolism, blood glucose, and blood lipid metabolism. Some&#xD;
        dietary intervention studies have found its effect on weight loss, sleep improvement, blood&#xD;
        glucose improvement, insulin sensitivity, β cell reactivity, blood pressure, oxidative&#xD;
        stress, and appetite improvement. This intervention study aims to investigate changes in&#xD;
        chronic disease risk factors according to the daily meal exposure time (from the first meal&#xD;
        to the last meal or snack) in healthy adult women.&#xD;
  &#xD;
        The subjects of this study are healthy adult women aged the 30s - 40s with a body mass index&#xD;
        (BMI) of 23 kg/m2 or a body fat rate of 28% or higher and would be excluded if the&#xD;
        participants have inconsistent eating patterns or weight changes of 5% or more over the past&#xD;
        three months, are pregnant or breastfeeding, are heavy drinkers (alcohol intake of 10 g/day,&#xD;
        300 cc), and are smokers.&#xD;
  &#xD;
        A total of 10 weeks of intervention are conducted. Two meal exposure time groups are&#xD;
        performed for four weeks each, and there is a two-week wash-out between different exposure&#xD;
        times. The total meal period per day would be limited to 8 hours ± 30 minutes for the TRF&#xD;
        group, and 14 hours ± 30 minutes for the EXF group. Each group will be divided into early&#xD;
        type (before 10 a.m.) and late type (after 10 a.m.) depending on the participants' first meal&#xD;
        timing and will be changed to another group in the second intervention period. During the&#xD;
        10-week study, blood (to collect genetic information related to blood lipids, blood sugar,&#xD;
        10ml) and urine (to collect metabolic indicators such as urine sodium, 15ml) samples would be&#xD;
        collected four times.&#xD;
  &#xD;
        Changes in evaluation variables (body composition indicators, urine indicators, or blood&#xD;
        indicators) before and after each intervention period will be tested using the paired t-test.&#xD;
        The association between meal time and changes in biomarkers will be tested by ANOVA using a&#xD;
        mixed model. The analysis would be adjusted for covariates related to lifestyle (sleeping&#xD;
        time, physical activity level, smoking status) and chrono-nutrition-related genetic&#xD;
        information.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change of body weight in kilogram before and after the intervention</measure>
      <time_frame>before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))</time_frame>
      <description>Direct measurement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change of body fat in kilogram before and after the intervention</measure>
      <time_frame>before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))</time_frame>
      <description>Direct measurement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change of waist circumference in centimeter before and after the intervention</measure>
      <time_frame>before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))</time_frame>
      <description>Direct measurement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change of fasting blood glucose (mg/dL)</measure>
      <time_frame>before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))</time_frame>
      <description>Direct measurement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of serum TG (mg/dL)</measure>
      <time_frame>before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))</time_frame>
      <description>Direct measurement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of serum HDL-C (mg/dL)</measure>
      <time_frame>before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))</time_frame>
      <description>Direct measurement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change of serum TC(mg/dL)</measure>
      <time_frame>before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))</time_frame>
      <description>Direct measurement</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Body Weight Maintenance</condition>
    <condition>Nutritional and Metabolic Diseases</condition>
    <arm_group>
      <arm_group_label>time restricted feeding</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>total feeding time (from the first meal or snack to the last) is assigned as 8 hours/day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>time extended feeding</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>total feeding time (from the first meal or snack to the last) is assigned as 14 hours/day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>time extended feeding</intervention_name>
      <description>Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 14 hours per day.</description>
      <arm_group_label>time restricted feeding</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>time restricted feeding</intervention_name>
      <description>Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 8 hours per day.</description>
      <arm_group_label>time extended feeding</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy adult women with a body mass index (BMI) of 23 kg/m2 or a body fat rate of 28%&#xD;
               or higher&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  whose eating patterns have not been consistent over the past three months who has&#xD;
               changed his or her weight in the past three months by more than 5% who has been&#xD;
               diagnosed with cardiovascular disease/cancer/diabetes/hypertension or who has taken&#xD;
               drugs for related diseases be pregnant or breast-feeding within the last three months&#xD;
               who drink too much (alcohol intake ≥ 10 g/day, about 300cc of beer, about 1 glass of&#xD;
               soju) who smoke&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sangah Shin, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chung-Ang University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sangah Shin, Ph.D</last_name>
      <phone>+82-31-670-3259</phone>
      <email>ivory8320@cau.ac.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lijuan Tan, Ph.D</last_name>
      <phone>+82-31-670-3259</phone>
      <email>tanlijuan@cau.ac.kr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Chuang-Ang University</name>
        <address>
          <city>Anseong</city>
          <state>Gyeonggi-do</state>
          <zip>17546</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sangah Shin, Ph.D</last_name>
        <phone>+82-31-670-3259</phone>
        <email>ivory8320@cau.ac.kr</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chung-Ang University</investigator_affiliation>
      <investigator_full_name>Sangah Shin</investigator_full_name>
      <investigator_title>Associated Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metabolic Diseases</mesh_term>
      <mesh_term>Body Weight</mesh_term>
    </condition_browse>
    <!-- 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/NCT05964179
  org study id: 1041078-20230217-BR-035
  nct id: NCT05964179
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study would recruit about 50 healthy adult women and randomly divide the participants
        into two groups for a ten-week crossover intervention study. The investigators aimed to
        observe the impact of daily feeding/fasting time on clinical metabolic biomarkers.
  Many nutritional epidemiological studies conducted among various population groups (Cohort
        study, RCT study) found that chrono-nutrition factors such as morning fasting, functional
        supplements like fish oils, intermittent fasting, and time-restricted feeding were related to
        weight management, cardiovascular metabolism, blood glucose, and blood lipid metabolism. Some
        dietary intervention studies have found its effect on weight loss, sleep improvement, blood
        glucose improvement, insulin sensitivity, β cell reactivity, blood pressure, oxidative
        stress, and appetite improvement. This intervention study aims to investigate changes in
        chronic disease risk factors according to the daily meal exposure time (from the first meal
        to the last meal or snack) in healthy adult women.
  
        The subjects of this study are healthy adult women aged the 30s - 40s with a body mass index
        (BMI) of 23 kg/m2 or a body fat rate of 28% or higher and would be excluded if the
        participants have inconsistent eating patterns or weight changes of 5% or more over the past
        three months, are pregnant or breastfeeding, are heavy drinkers (alcohol intake of 10 g/day,
        300 cc), and are smokers.
  
        A total of 10 weeks of intervention are conducted. Two meal exposure time groups are
        performed for four weeks each, and there is a two-week wash-out between different exposure
        times. The total meal period per day would be limited to 8 hours ± 30 minutes for the TRF
        group, and 14 hours ± 30 minutes for the EXF group. Each group will be divided into early
        type (before 10 a.m.) and late type (after 10 a.m.) depending on the participants' first meal
        timing and will be changed to another group in the second intervention period. During the
        10-week study, blood (to collect genetic information related to blood lipids, blood sugar,
        10ml) and urine (to collect metabolic indicators such as urine sodium, 15ml) samples would be
        collected four times.
  
        Changes in evaluation variables (body composition indicators, urine indicators, or blood
        indicators) before and after each intervention period will be tested using the paired t-test.
        The association between meal time and changes in biomarkers will be tested by ANOVA using a
        mixed model. The analysis would be adjusted for covariates related to lifestyle (sleeping
        time, physical activity level, smoking status) and chrono-nutrition-related genetic
        information.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: Single (Investigator)
  measure: change of body weight in kilogram before and after the intervention
  time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
  description: Direct measurement
  measure: change of body fat in kilogram before and after the intervention
  time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
  description: Direct measurement
  measure: change of waist circumference in centimeter before and after the intervention
  time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
  description: Direct measurement
  measure: change of fasting blood glucose (mg/dL)
  time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
  description: Direct measurement
  measure: change of serum TG (mg/dL)
  time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
  description: Direct measurement
  measure: change of serum HDL-C (mg/dL)
  time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
  description: Direct measurement
  measure: change of serum TC(mg/dL)
  time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
  description: Direct measurement
  arm group label: time restricted feeding
  arm group type: Experimental
  description: total feeding time (from the first meal or snack to the last) is assigned as 8 hours/day.
  arm group label: time extended feeding
  arm group type: Experimental
  description: total feeding time (from the first meal or snack to the last) is assigned as 14 hours/day.
  intervention type: Behavioral
  intervention name: time extended feeding
  description: Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 14 hours per day.
  arm group label: time restricted feeding
  intervention type: Behavioral
  intervention name: time restricted feeding
  description: Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 8 hours per day.
  arm group label: time extended feeding
  criteria: 
  gender: Female
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sangah Shin, Ph.D
  role: Principal Investigator
  affiliation: Chung-Ang University
  last name: Sangah Shin, Ph.D
  phone: +82-31-670-3259
  email: ivory8320@cau.ac.kr
  last name: Lijuan Tan, Ph.D
  phone: +82-31-670-3259
  email: tanlijuan@cau.ac.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Chung-Ang University
  investigator full name: Sangah Shin
  investigator title: Associated Professor
  mesh term: Metabolic Diseases
  mesh term: Body Weight