<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/NCT03792282</url>
  </required_header>
  <id_info>
    <org_study_id>KYH2018-017</org_study_id>
    <nct_id>NCT03792282</nct_id>
  </id_info>
  <brief_title>Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)</brief_title>
  <acronym>TRF-PCOS</acronym>
  <official_title>Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome(PCOS): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Xiamen 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>
      The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe&#xD;
      and effective regimen to improve insulin resistance and decrease body weight in&#xD;
      overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced&#xD;
      energy restriction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intermittent fasting regimens involve periods fasting followed by periods of eating freely.&#xD;
      Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening&#xD;
      the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in&#xD;
      adults with obesity. Accumulating evidence suggests that TRF is an effective means of&#xD;
      decreasing body weight and improving insulin resistance but did not have any negative impact&#xD;
      on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary&#xD;
      syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70&#xD;
      % of women with PCOS are obese or overweight, and obesity is associated with insulin&#xD;
      resistance. Since many women with PCOS seem to have insulin resistance, compensatory&#xD;
      hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of&#xD;
      ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important&#xD;
      to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine&#xD;
      whether TRF is a safe and effective regimen to improve insulin resistance and decrease body&#xD;
      weight in overweight/obese PCOS patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in body weight (Kilograms)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Changes in body weight (Kilograms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in insulin resistance</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Insulin resistance will be assessed by HOMA-IR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in waist circumference (cm)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in abdominal circumference (cm)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic pressure（SBP）</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diastolic pressure (DBP）</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in β cell function</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>β cell function will be assessed by HOMA-β</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL-c level</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TG level</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CHO level</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in liver fiber</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systemic Inflammatory biomarkers</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Oxidative stress markers</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depressive symptoms as assessed by Patient Health Questionnaire-9</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in time to return to normal menstrual cycle</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Changes in time to return to normal menstrual cycle</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Polycystic Ovary Syndrome (PCOS)</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>TRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will receive a general lifestyle counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time Restricted Feeding</intervention_name>
    <description>Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).</description>
    <arm_group_label>TRF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Participants receive a general lifestyle counseling.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  BMI≥24kg/m2&#xD;
&#xD;
          -  Polycystic ovary syndrome has been diagnosed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  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;
          -  The body weight fluctuated more than 5% in recent 3 months.&#xD;
&#xD;
          -  Liver and kidney dysfunction: renal impairment, creatinine clearance rate &lt; 30&#xD;
             mL/min/1.73 m2, transaminase increased, more than three times higher than the normal&#xD;
             limit;&#xD;
&#xD;
          -  History of serious cardiovascular or cerebrovascular disease (angina, myocardial&#xD;
             infarction or stroke) in the past 6 months;&#xD;
&#xD;
          -  History of thyroid diseases;&#xD;
&#xD;
          -  Having been in pregnancy.&#xD;
&#xD;
          -  Researchers believe that there are any factors that affect assessing subjects'&#xD;
             participation in trial.&#xD;
&#xD;
          -  History of malignant tumors;&#xD;
&#xD;
          -  History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;&#xD;
&#xD;
          -  Currently participating in weight loss programs or weight change in the past 3 months&#xD;
             (&gt; 5% current body weight)&#xD;
&#xD;
          -  Patients who cannot be followed for 16 months (due to a health situation or migration)&#xD;
&#xD;
          -  Patients who are unwilling or unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only women have the PCOS.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Changqin Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The first afilliated hospital of Xiamen university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The first afilliated hospital of Xiamen university</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>August 19, 2023</last_update_submitted>
  <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polycystic Ovary Syndrome</keyword>
  <keyword>Overweight and Obesity</keyword>
  <keyword>Time-Restricted Feeding</keyword>
  <keyword>Intermittent fasting regimens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Syndrome</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/NCT03792282
org study id: KYH2018-017
nct id: NCT03792282
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe
      and effective regimen to improve insulin resistance and decrease body weight in
      overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced
      energy restriction.
Intermittent fasting regimens involve periods fasting followed by periods of eating freely.
      Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening
      the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in
      adults with obesity. Accumulating evidence suggests that TRF is an effective means of
      decreasing body weight and improving insulin resistance but did not have any negative impact
      on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary
      syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70
      % of women with PCOS are obese or overweight, and obesity is associated with insulin
      resistance. Since many women with PCOS seem to have insulin resistance, compensatory
      hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of
      ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important
      to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine
      whether TRF is a safe and effective regimen to improve insulin resistance and decrease body
      weight in overweight/obese PCOS patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in body weight (Kilograms)
time frame: Baseline and 16 weeks
description: Changes in body weight (Kilograms)
measure: Change in insulin resistance
time frame: Baseline and 16 weeks
description: Insulin resistance will be assessed by HOMA-IR
measure: Changes in waist circumference (cm)
time frame: Baseline and 16 weeks
measure: Changes in abdominal circumference (cm)
time frame: Baseline and 16 weeks
measure: Changes in systolic pressure（SBP）
time frame: Baseline and 16 weeks
measure: Changes in diastolic pressure (DBP）
time frame: Baseline and 16 weeks
measure: Change in β cell function
time frame: Baseline and 16 weeks
description: β cell function will be assessed by HOMA-β
measure: Change in LDL-c level
time frame: Baseline and 16 weeks
measure: Change in TG level
time frame: Baseline and 16 weeks
measure: Change in CHO level
time frame: Baseline and 16 weeks
measure: Change in liver fiber
time frame: Baseline and 16 weeks
description: liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan
measure: Changes in systemic Inflammatory biomarkers
time frame: Baseline and 16 weeks
description: Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).
measure: Changes in Oxidative stress markers
time frame: Baseline and 16 weeks
description: Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.
measure: Change in depressive symptoms as assessed by Patient Health Questionnaire-9
time frame: Baseline and 16 weeks
measure: Change in quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
time frame: Baseline and 16 weeks
measure: Changes in time to return to normal menstrual cycle
time frame: Baseline and 16 weeks
description: Changes in time to return to normal menstrual cycle
arm group label: TRF
arm group type: Experimental
description: Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.
arm group label: Usual care
arm group type: Active Comparator
description: Participants in this group will receive a general lifestyle counseling.
intervention type: Behavioral
intervention name: Time Restricted Feeding
description: Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).
arm group label: TRF
intervention type: Behavioral
intervention name: Usual care
description: Participants receive a general lifestyle counseling.
arm group label: Usual care
criteria: 
gender: Female
gender based: Yes
gender description: Only women have the PCOS.
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Changqin Liu, MD
role: Principal Investigator
affiliation: The first afilliated hospital of Xiamen university
facility: 
country: China
responsible party type: Sponsor
mesh term: Polycystic Ovary Syndrome
mesh term: Overweight
mesh term: Syndrome
sharing ipd: No