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/NCT05996042</url>
    </required_header>
    <id_info>
      <org_study_id>RCT of Sedentary Population</org_study_id>
      <nct_id>NCT05996042</nct_id>
    </id_info>
    <brief_title>Time-restricted Diet Combined With Multimodal Aerobic Exercise</brief_title>
    <official_title>A Randomized Controlled Trial of Time-restricted Diet Combined With Multimodal Aerobic Exercise Intervention on Cardiovascular and Metabolic Health in a Sedentary Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking 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>
        Objective: This study aims to compare the effects of a combination of time-restricted diet&#xD;
        and multimodal aerobic exercise (calisthenics, yoga, and comprehensive physical training) on&#xD;
        cardiovascular and metabolic health in a sedentary population with both interventions alone.&#xD;
  &#xD;
        Study design. Randomized controlled trial Participants: Sedentary (average sitting time&#xD;
        greater than 6 hours per day over the past six months, and average moderate-intensity&#xD;
        physical activity less than 125 minutes per week or vigorous-intensity physical activity less&#xD;
        than 75 minutes per week as assessed by the International Physical Activity Questionnaire).&#xD;
  &#xD;
        Sample size: 81 Study grouping and intervention measures: Subjects who signed informed&#xD;
        consent and met the inclusion/exclusion conditions were randomly divided into the following&#xD;
        three groups according to gender stratification, with 27 participants in each group: single&#xD;
        time-limited diet group, single multi-mode aerobic exercise (aerobics, yoga and comprehensive&#xD;
        physical training) group, and combination of time-limited diet and multi-mode aerobic&#xD;
        exercise group. The subjects who received the time-restricted diet intervention were allowed&#xD;
        to eat only from 7am to 3pm on Tuesdays, Thursdays and Saturdays, and were allowed to drink&#xD;
        pure water only during the rest of the day. The subjects who received the multi-mode aerobic&#xD;
        exercise intervention carried out the exercise intervention from 6:00 PM to 7:00 PM on&#xD;
        Monday, Wednesday and Friday under the unified guidance of the physical education teacher of&#xD;
        the Medical Department. All subjects did not limit their total daily energy intake. The&#xD;
        intervention lasted eight weeks.&#xD;
  &#xD;
        Outcome evaluation indicators: The main indicators of this study were body composition (body&#xD;
        fat, muscle mass, fat-free weight, body weight, BMI, body fat percentage, total body water,&#xD;
        protein, inorganic salts, limb muscle and extracellular water ratio).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subjects who signed the informed consent and met the inclusion criteria were randomly divided&#xD;
        into the following three groups according to gender stratification:&#xD;
  &#xD;
          1. Single time-limited diet group: Subjects in this group were given a time-limited diet&#xD;
             every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on&#xD;
             the same day, and only allowed to drink purified water during other periods, namely an&#xD;
             8-hour eating window and a 16-hour fasting period. Total daily energy intake is not&#xD;
             restricted, and food selection is recommended in accordance with the Dietary Guidelines&#xD;
             for Chinese Residents (2022). Subjects in this group were required to maintain the&#xD;
             original physical activity frequency;&#xD;
  &#xD;
          2. Independent multi-mode aerobic exercise group: Subjects in this group will do multi-mode&#xD;
             aerobic exercise from 6:00 PM to 7:00 PM on Mondays, Wednesdays and Fridays under the&#xD;
             unified guidance of the physical education teacher of the Health Science Department (see&#xD;
             Attachment 3 for details). The venue is the gymnasium and sports ground of Peking&#xD;
             University Health Science Center, and the exercise items include aerobics, yoga and&#xD;
             comprehensive physical training, see attachment for details. Subjects in this group do&#xD;
             not limit their daily total energy intake, and it is recommended to choose food&#xD;
             according to the Dietary Guidelines for Chinese Residents (2022).&#xD;
  &#xD;
          3. Combined group of time-limited diet and multi-mode aerobic exercise: Subjects in this&#xD;
             group received the same time-limited diet intervention according to the above&#xD;
             requirements of the single-mode diet group every Tuesday, Thursday and Saturday, and the&#xD;
             same multi-mode aerobic exercise intervention according to the above requirements of the&#xD;
             single-mode aerobic exercise group every Monday, Wednesday and Friday. Total daily&#xD;
             energy intake is not restricted, and food selection is recommended in accordance with&#xD;
             the Dietary Guidelines for Chinese Residents (2022).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">October 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 20, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Body fat</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle mass</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fat-free weight</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>body weight</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method in Kg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>body weight</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method in Kg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body fat percentage</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method in %</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body fat percentage</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method in %</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body water</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body water</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle mass</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body fat</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fat-free weight</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, using the bioresistive method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body mass index</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body mass index</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Baseline survey</time_frame>
      <description>The measurements are made by a professional using a tape measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>The measurements are made by a professional using a tape measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hip circumference</measure>
      <time_frame>Baseline survey</time_frame>
      <description>The measurements are made by a professional using a tape measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hip circumference</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>The measurements are made by a professional using a tape measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Baseline survey</time_frame>
      <description>The measurement was carried out using an electronic sphygmomanometer, and the average value was measured three times in the resting state</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>The measurement was carried out using an electronic sphygmomanometer, and the average value was measured three times in the resting state</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>Baseline survey</time_frame>
      <description>The heart rate band was used for measurement, and the resting state was measured three times to take the average value</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>The heart rate band was used for measurement, and the resting state was measured three times to take the average value</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Lipid</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Fasting blood lipid (TC, TG, HDL-C, LDL-C),Blood is drawn by a trained nurse and blood biochemical tests are performed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Lipid</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Including TC, TG, HDL-C, LDL-C ,blood is drawn by a trained nurse and blood biochemical tests are performed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>urine routine</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Including urinary protein, urinary creatinine, urine collection was followed by routine urine testing at the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>urine routine</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Including urinary protein, urinary creatinine, urine collection was followed by routine urine testing at the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaire survey</measure>
      <time_frame>Baseline survey</time_frame>
      <description>Demographic characteristics questionnaire, 4-day 24-hour dietary review, international physical activity questionnaire, sleep quality questionnaire, CNAQ appetite questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaire survey</measure>
      <time_frame>8 weeks after baseline survey</time_frame>
      <description>Demographic characteristics questionnaire, 4-day 24-hour dietary review, international physical activity questionnaire, sleep quality questionnaire, CNAQ appetite questionnaire</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">81</enrollment>
    <condition>Healthy Population</condition>
    <arm_group>
      <arm_group_label>Time-restricted diet group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Subjects in this group were given a limited diet every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on the same day, and only allowed to drink purified water during other periods, namely an 8-hour eating window and a 16-hour fasting period</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Multimode aerobics group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Subjects in this group performed multi-mode aerobic exercise from 6:00 PM to 7:00 PM on Monday, Wednesday and Friday under the unified guidance of the physical education teacher of the Health Science Center in the gymnasium and sports field of Peking University Health Science Center, including aerobics, yoga and comprehensive physical training</description>
    </arm_group>
    <arm_group>
      <arm_group_label>A combination of time-restricted diet and multimodal aerobic exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects in this group received the same time-limited dietary intervention every Tuesday, Thursday and Saturday according to the above requirements of the single time-limited dietary group, and the same multi-mode aerobic exercise intervention every Monday, Wednesday and Friday according to the above requirements of the single multi-mode aerobic exercise group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Time-restricted diet</intervention_name>
      <description>On Tuesdays, Thursdays and Saturdays, only eating is allowed between 7am and 3pm. The rest of the time, only drinking pure water is allowed, which is an eight-hour eating window and a 16-hour fasting period.&#xD;
  On Mondays, Wednesdays and Fridays, under the unified guidance of the physical education teachers of the Health Science Department from 6:00 PM to 7:00 PM, the venue is the gymnasium and sports field of Peking University Health Science Center. The exercise items include aerobics, yoga and comprehensive physical training.</description>
      <arm_group_label>A combination of time-restricted diet and multimodal aerobic exercise</arm_group_label>
      <arm_group_label>Multimode aerobics group</arm_group_label>
      <arm_group_label>Time-restricted diet group</arm_group_label>
      <other_name>Multimodal aerobic exercise</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. In the past six months, the average daily sitting time was more than 6 hours, and the&#xD;
               average weekly moderate-intensity physical activity time was less than 125 minutes or&#xD;
               high-intensity physical activity time was less than 75 minutes as assessed by the&#xD;
               International Physical Activity Questionnaire (JAMA Intern Med. 2022 Jun 1;&#xD;
               182(6):650-659, J Sport Health Sci. 2022 Mar; 11(2): 164 -- 171. And Global&#xD;
               recommendations on physical activity for health);&#xD;
  &#xD;
            2. BMI of 18.5-30 kg/m 2, age 18-50, where BMI= weight (kg)/height 2 (m);&#xD;
  &#xD;
            3. Weight change less than 3 kg in the last six months;&#xD;
  &#xD;
            4. Unlimited hours or other types of fasting, such as alternate-day fasting or simulated&#xD;
               fasting diets;&#xD;
  &#xD;
            5. No cardiovascular metabolic diseases such as hypertension, type 2 diabetes, chronic&#xD;
               kidney disease, coronary heart disease and stroke;&#xD;
  &#xD;
            6. No movement disorder related diseases, no sports injury history in the past six&#xD;
               months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Weigh more than 100 kg;&#xD;
  &#xD;
            2. Used weight-loss drugs or dietary supplements and used hormone drugs in the past six&#xD;
               months;&#xD;
  &#xD;
            3. Abnormal liver and kidney function was found by laboratory examination;&#xD;
  &#xD;
            4. Women who are pregnant, lactating or planning to become pregnant in the near future;&#xD;
  &#xD;
            5. Still unable to skillfully use smart phones and sports bracelets after training;&#xD;
  &#xD;
            6. Other circumstances deemed unsuitable for participation in the study by the&#xD;
               researchers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qihuang Gong, Dr</last_name>
      <role>Study Chair</role>
      <affiliation>Peking University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tao Huang, Dr</last_name>
      <phone>13488745828</phone>
      <phone_ext>+86</phone_ext>
      <email>huangtao@bjmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yimin Zhao, Dr</last_name>
      <phone>17810788503</phone>
      <phone_ext>+86</phone_ext>
      <email>2116390124@bjmu.edu.cn</email>
    </overall_contact_backup>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sedentary</keyword>
    <keyword>Time-restricted diet</keyword>
    <keyword>Exercise intervention</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The anonymous data is then shared with relevant collaborators</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After the data is anonymized</ipd_time_frame>
      <ipd_access_criteria>Need to reach an agreement and sign a collaboration agreement with the researcher</ipd_access_criteria>
    </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/NCT05996042
  org study id: RCT of Sedentary Population
  nct id: NCT05996042
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Objective: This study aims to compare the effects of a combination of time-restricted diet
        and multimodal aerobic exercise (calisthenics, yoga, and comprehensive physical training) on
        cardiovascular and metabolic health in a sedentary population with both interventions alone.
  
        Study design. Randomized controlled trial Participants: Sedentary (average sitting time
        greater than 6 hours per day over the past six months, and average moderate-intensity
        physical activity less than 125 minutes per week or vigorous-intensity physical activity less
        than 75 minutes per week as assessed by the International Physical Activity Questionnaire).
  
        Sample size: 81 Study grouping and intervention measures: Subjects who signed informed
        consent and met the inclusion/exclusion conditions were randomly divided into the following
        three groups according to gender stratification, with 27 participants in each group: single
        time-limited diet group, single multi-mode aerobic exercise (aerobics, yoga and comprehensive
        physical training) group, and combination of time-limited diet and multi-mode aerobic
        exercise group. The subjects who received the time-restricted diet intervention were allowed
        to eat only from 7am to 3pm on Tuesdays, Thursdays and Saturdays, and were allowed to drink
        pure water only during the rest of the day. The subjects who received the multi-mode aerobic
        exercise intervention carried out the exercise intervention from 6:00 PM to 7:00 PM on
        Monday, Wednesday and Friday under the unified guidance of the physical education teacher of
        the Medical Department. All subjects did not limit their total daily energy intake. The
        intervention lasted eight weeks.
  
        Outcome evaluation indicators: The main indicators of this study were body composition (body
        fat, muscle mass, fat-free weight, body weight, BMI, body fat percentage, total body water,
        protein, inorganic salts, limb muscle and extracellular water ratio).
  Subjects who signed the informed consent and met the inclusion criteria were randomly divided
        into the following three groups according to gender stratification:
  
          1. Single time-limited diet group: Subjects in this group were given a time-limited diet
             every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on
             the same day, and only allowed to drink purified water during other periods, namely an
             8-hour eating window and a 16-hour fasting period. Total daily energy intake is not
             restricted, and food selection is recommended in accordance with the Dietary Guidelines
             for Chinese Residents (2022). Subjects in this group were required to maintain the
             original physical activity frequency;
  
          2. Independent multi-mode aerobic exercise group: Subjects in this group will do multi-mode
             aerobic exercise from 6:00 PM to 7:00 PM on Mondays, Wednesdays and Fridays under the
             unified guidance of the physical education teacher of the Health Science Department (see
             Attachment 3 for details). The venue is the gymnasium and sports ground of Peking
             University Health Science Center, and the exercise items include aerobics, yoga and
             comprehensive physical training, see attachment for details. Subjects in this group do
             not limit their daily total energy intake, and it is recommended to choose food
             according to the Dietary Guidelines for Chinese Residents (2022).
  
          3. Combined group of time-limited diet and multi-mode aerobic exercise: Subjects in this
             group received the same time-limited diet intervention according to the above
             requirements of the single-mode diet group every Tuesday, Thursday and Saturday, and the
             same multi-mode aerobic exercise intervention according to the above requirements of the
             single-mode aerobic exercise group every Monday, Wednesday and Friday. Total daily
             energy intake is not restricted, and food selection is recommended in accordance with
             the Dietary Guidelines for Chinese Residents (2022).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Body fat
  time frame: Baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method
  measure: Muscle mass
  time frame: Baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method
  measure: Fat-free weight
  time frame: Baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method
  measure: body weight
  time frame: Baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method in Kg
  measure: body weight
  time frame: 8 weeks after baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method in Kg
  measure: Body fat percentage
  time frame: Baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method in %
  measure: Body fat percentage
  time frame: 8 weeks after baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method in %
  measure: Body water
  time frame: Baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method
  measure: Body water
  time frame: 8 weeks after baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method
  measure: Muscle mass
  time frame: 8 weeks after baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method
  measure: Body fat
  time frame: 8 weeks after baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method
  measure: Fat-free weight
  time frame: 8 weeks after baseline survey
  description: Measurements were made using the Inbody 770, using the bioresistive method
  measure: Body mass index
  time frame: Baseline survey
  description: Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared
  measure: Body mass index
  time frame: 8 weeks after baseline survey
  description: Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared
  measure: Waist circumference
  time frame: Baseline survey
  description: The measurements are made by a professional using a tape measure
  measure: Waist circumference
  time frame: 8 weeks after baseline survey
  description: The measurements are made by a professional using a tape measure
  measure: Hip circumference
  time frame: Baseline survey
  description: The measurements are made by a professional using a tape measure
  measure: Hip circumference
  time frame: 8 weeks after baseline survey
  description: The measurements are made by a professional using a tape measure
  measure: Blood pressure
  time frame: Baseline survey
  description: The measurement was carried out using an electronic sphygmomanometer, and the average value was measured three times in the resting state
  measure: Blood pressure
  time frame: 8 weeks after baseline survey
  description: The measurement was carried out using an electronic sphygmomanometer, and the average value was measured three times in the resting state
  measure: Heart rate
  time frame: Baseline survey
  description: The heart rate band was used for measurement, and the resting state was measured three times to take the average value
  measure: Heart rate
  time frame: 8 weeks after baseline survey
  description: The heart rate band was used for measurement, and the resting state was measured three times to take the average value
  measure: Blood Lipid
  time frame: Baseline survey
  description: Fasting blood lipid (TC, TG, HDL-C, LDL-C),Blood is drawn by a trained nurse and blood biochemical tests are performed
  measure: Blood Lipid
  time frame: 8 weeks after baseline survey
  description: Including TC, TG, HDL-C, LDL-C ,blood is drawn by a trained nurse and blood biochemical tests are performed
  measure: urine routine
  time frame: Baseline survey
  description: Including urinary protein, urinary creatinine, urine collection was followed by routine urine testing at the hospital
  measure: urine routine
  time frame: 8 weeks after baseline survey
  description: Including urinary protein, urinary creatinine, urine collection was followed by routine urine testing at the hospital
  measure: Questionnaire survey
  time frame: Baseline survey
  description: Demographic characteristics questionnaire, 4-day 24-hour dietary review, international physical activity questionnaire, sleep quality questionnaire, CNAQ appetite questionnaire
  measure: Questionnaire survey
  time frame: 8 weeks after baseline survey
  description: Demographic characteristics questionnaire, 4-day 24-hour dietary review, international physical activity questionnaire, sleep quality questionnaire, CNAQ appetite questionnaire
  arm group label: Time-restricted diet group
  arm group type: Other
  description: Subjects in this group were given a limited diet every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on the same day, and only allowed to drink purified water during other periods, namely an 8-hour eating window and a 16-hour fasting period
  arm group label: Multimode aerobics group
  arm group type: Other
  description: Subjects in this group performed multi-mode aerobic exercise from 6:00 PM to 7:00 PM on Monday, Wednesday and Friday under the unified guidance of the physical education teacher of the Health Science Center in the gymnasium and sports field of Peking University Health Science Center, including aerobics, yoga and comprehensive physical training
  arm group label: A combination of time-restricted diet and multimodal aerobic exercise
  arm group type: Experimental
  description: Subjects in this group received the same time-limited dietary intervention every Tuesday, Thursday and Saturday according to the above requirements of the single time-limited dietary group, and the same multi-mode aerobic exercise intervention every Monday, Wednesday and Friday according to the above requirements of the single multi-mode aerobic exercise group.
  intervention type: Behavioral
  intervention name: Time-restricted diet
  description: On Tuesdays, Thursdays and Saturdays, only eating is allowed between 7am and 3pm. The rest of the time, only drinking pure water is allowed, which is an eight-hour eating window and a 16-hour fasting period.
  On Mondays, Wednesdays and Fridays, under the unified guidance of the physical education teachers of the Health Science Department from 6:00 PM to 7:00 PM, the venue is the gymnasium and sports field of Peking University Health Science Center. The exercise items include aerobics, yoga and comprehensive physical training.
  arm group label: A combination of time-restricted diet and multimodal aerobic exercise
  arm group label: Multimode aerobics group
  arm group label: Time-restricted diet group
  other name: Multimodal aerobic exercise
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Qihuang Gong, Dr
  role: Study Chair
  affiliation: Peking University
  last name: Tao Huang, Dr
  phone: 13488745828
  phone ext: +86
  email: huangtao@bjmu.edu.cn
  last name: Yimin Zhao, Dr
  phone: 17810788503
  phone ext: +86
  email: 2116390124@bjmu.edu.cn
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: The anonymous data is then shared with relevant collaborators
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: After the data is anonymized
  ipd access criteria: Need to reach an agreement and sign a collaboration agreement with the researcher