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/NCT06031753</url>
    </required_header>
    <id_info>
      <org_study_id>AYUSOP22</org_study_id>
      <nct_id>NCT06031753</nct_id>
    </id_info>
    <brief_title>Effects of Intermittent Fasting on Polycystic Ovary Syndrome (PCOS) Compared to Standard Treatment</brief_title>
    <official_title>Time-restricted Eating as a Novel Approach to PCOS Remission, Compared to Guideline's Standard Hormonal Treatment.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centro Medico ABC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento</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 purpose of this study is to assess the effects of Time restricted eating in patients&#xD;
        diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential risks, all patients were given a written&#xD;
        informed consent. Patients were recruited through social media and digital questionnaires, to&#xD;
        make sure they met the criteria. There was a semi aleatory distribution of the patients into&#xD;
        three different groups, one group underwent time restricted eating with no hormonal treatment&#xD;
        (TRE group), the second group received hormonal treatment combined with time restricted&#xD;
        eating (combined group) and the last group received only hormonal treatment (HT). PCOS was&#xD;
        diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood&#xD;
        samples and self reported menstrual cycle.&#xD;
  &#xD;
        Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal&#xD;
        status, including insulin and glucose.&#xD;
  &#xD;
        Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin&#xD;
        resistance, as well as metabolic disfunction.&#xD;
  &#xD;
        After data collection, statistical analyses was done to determine the effect of the different&#xD;
        approaches.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 3, 2021</start_date>
    <completion_date type="Actual">October 11, 2022</completion_date>
    <primary_completion_date type="Actual">November 27, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>group 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eating</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PCOS Rotterdam criteria</measure>
      <time_frame>3 months</time_frame>
      <description>Ovary volume &gt;9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Insulin resistance (IR)</measure>
      <time_frame>3 months</time_frame>
      <description>HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <condition>Insulin Resistance</condition>
    <arm_group>
      <arm_group_label>TRE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Only time restricted eating was carried on by this arm, having the first meal of the day at 12:00hrs and last meal of the day at 18:00hrs. No other medication was allowed during the study for this group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TRE-HT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>They carried on Time Restricted eating, in combination with the oral contraceptives used for the standard hormonal treatment. First meal of the day at 12:00hrs and last meal of the day at 18:00hrs. Other than oral contraceptives, no medication was allowed during the 3 months of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HT</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No time restricted eating was practiced by this group, only oral contraceptives were taken, serving as the control group by having the standard hormonal treatment. No modification to their daily habits and routine was made.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Time restricted eating</intervention_name>
      <description>Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study.</description>
      <arm_group_label>TRE</arm_group_label>
      <arm_group_label>TRE-HT</arm_group_label>
      <other_name>time restricted eating with hormonal treatment</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 20 - 35 years&#xD;
  &#xD;
            -  Mild to moderate exercise at least 4 times per week&#xD;
  &#xD;
            -  Body Mass Index (BMI) of 20-24.9&#xD;
  &#xD;
            -  Diagnosis of PCOS by Rotterdam criteria&#xD;
  &#xD;
            -  Type of oral contraceptives: combined (estrogens and progestins) in group 1 and 2.&#xD;
  &#xD;
            -  PCOS Phenotype A, B, C&#xD;
  &#xD;
            -  nulliparity&#xD;
  &#xD;
            -  Signed informed consent letter&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Menopause or perimenopause&#xD;
  &#xD;
            -  Night work shifts&#xD;
  &#xD;
            -  Phenotype D (without hyperandrogenism)&#xD;
  &#xD;
            -  Associated pathologies such as diabetes mellitus, arterial hypertension, metabolic&#xD;
               syndrome, neoplasms, autoimmune diseases.&#xD;
  &#xD;
            -  Intake of medications on a regular basis, not including oral contraceptives for group&#xD;
               1 and 2.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Centro Médico ABC</name>
        <address>
          <city>Mexico city</city>
          <zip>05300</zip>
          <country>Mexico</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 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 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento</investigator_affiliation>
      <investigator_full_name>Isabela von Damm Longoria</investigator_full_name>
      <investigator_title>Principal 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>Insulin Resistance</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06031753
  org study id: AYUSOP22
  nct id: NCT06031753
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess the effects of Time restricted eating in patients
        diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.
  After being informed about the study and potential risks, all patients were given a written
        informed consent. Patients were recruited through social media and digital questionnaires, to
        make sure they met the criteria. There was a semi aleatory distribution of the patients into
        three different groups, one group underwent time restricted eating with no hormonal treatment
        (TRE group), the second group received hormonal treatment combined with time restricted
        eating (combined group) and the last group received only hormonal treatment (HT). PCOS was
        diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood
        samples and self reported menstrual cycle.
  
        Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal
        status, including insulin and glucose.
  
        Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin
        resistance, as well as metabolic disfunction.
  
        After data collection, statistical analyses was done to determine the effect of the different
        approaches.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: group 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eating
  primary purpose: Treatment
  masking: None (Open Label)
  measure: PCOS Rotterdam criteria
  time frame: 3 months
  description: Ovary volume >9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.
  measure: Insulin resistance (IR)
  time frame: 3 months
  description: HOMA-IR was calculated with insulin and glucose fasting levels to determine the severity of insulin resistance
  arm group label: TRE
  arm group type: Experimental
  description: Only time restricted eating was carried on by this arm, having the first meal of the day at 12:00hrs and last meal of the day at 18:00hrs. No other medication was allowed during the study for this group.
  arm group label: TRE-HT
  arm group type: Experimental
  description: They carried on Time Restricted eating, in combination with the oral contraceptives used for the standard hormonal treatment. First meal of the day at 12:00hrs and last meal of the day at 18:00hrs. Other than oral contraceptives, no medication was allowed during the 3 months of the study.
  arm group label: HT
  arm group type: No Intervention
  description: No time restricted eating was practiced by this group, only oral contraceptives were taken, serving as the control group by having the standard hormonal treatment. No modification to their daily habits and routine was made.
  intervention type: Behavioral
  intervention name: Time restricted eating
  description: Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study.
  arm group label: TRE
  arm group label: TRE-HT
  other name: time restricted eating with hormonal treatment
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: No
  facility: 
  country: Mexico
  responsible party type: Principal Investigator
  investigator affiliation: Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
  investigator full name: Isabela von Damm Longoria
  investigator title: Principal investigator
  mesh term: Polycystic Ovary Syndrome
  mesh term: Insulin Resistance
  mesh term: Syndrome
  sharing ipd: Undecided