<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/NCT04452968</url>
  </required_header>
  <id_info>
    <org_study_id>33</org_study_id>
    <nct_id>NCT04452968</nct_id>
  </id_info>
  <brief_title>Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome</brief_title>
  <official_title>Intermittent Fasting and Polycystic Ovarian Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karachi Medical and Dental College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aziz Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karachi Medical and Dental College</source>
  <oversight_info>
    <has_dmc>Yes</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) has been emerging as a potential weight loss strategy that&#xD;
      avoids major dietary changes but achieves strong effects. It also improves insulin&#xD;
      sensitivity through increased human growth hormone. This effect helps to improve the root&#xD;
      cause of weight gain and has additional benefits for women with PCOS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</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>weight loss in kg</measure>
    <time_frame>in 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>decrease in body fat percentage</measure>
    <time_frame>in 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fasting plasma insulin</measure>
    <time_frame>in 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure in mm Hg</measure>
    <time_frame>in 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Polycystic Ovarian Syndrome</condition>
  <condition>Weight Loss</condition>
  <condition>Intermittent Fasting</condition>
  <arm_group>
    <arm_group_label>intermittent fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.&#xD;
Women were told about timed restricted feeding. They were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>caloric restriction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>intermittent fasting</intervention_name>
    <description>Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.</description>
    <arm_group_label>intermittent fasting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Caloric restriction</intervention_name>
    <description>Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.</description>
    <arm_group_label>caloric restriction</arm_group_label>
    <arm_group_label>intermittent fasting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCOS as described by Rotterdam's criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  endocrine disorders&#xD;
&#xD;
          -  diabetic&#xD;
&#xD;
          -  hypertensive&#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;
          -  pregnant&#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>females</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rubina Izhar</last_name>
    <role>Study Chair</role>
    <affiliation>Aziz Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aziz Medical Center</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74600</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karachi Medical and Dental College</investigator_affiliation>
    <investigator_full_name>samia husain</investigator_full_name>
    <investigator_title>clinical investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Weight Loss</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/NCT04452968
org study id: 33
nct id: NCT04452968
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that
      avoids major dietary changes but achieves strong effects. It also improves insulin
      sensitivity through increased human growth hormone. This effect helps to improve the root
      cause of weight gain and has additional benefits for women with PCOS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: weight loss in kg
time frame: in 3 months
measure: decrease in body fat percentage
time frame: in 3 months
measure: fasting plasma insulin
time frame: in 3 months
measure: blood pressure in mm Hg
time frame: in 3 months
arm group label: intermittent fasting
arm group type: Experimental
description: Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.
Women were told about timed restricted feeding. They were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.
arm group label: caloric restriction
arm group type: Active Comparator
description: Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.
intervention type: Behavioral
intervention name: intermittent fasting
description: Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.
arm group label: intermittent fasting
intervention type: Behavioral
intervention name: Caloric restriction
description: Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.
arm group label: caloric restriction
arm group label: intermittent fasting
criteria: 
gender: Female
gender based: Yes
gender description: females
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: Rubina Izhar
role: Study Chair
affiliation: Aziz Medical Center
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Karachi Medical and Dental College
investigator full name: samia husain
investigator title: clinical investigator
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Weight Loss
sharing ipd: No