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/NCT05983224</url>
    </required_header>
    <id_info>
      <org_study_id>43003154</org_study_id>
      <nct_id>NCT05983224</nct_id>
    </id_info>
    <brief_title>Effect of Quercetin Supplementation on Endometriosis Outcomes</brief_title>
    <official_title>Effect of Quercetin Supplementation on Glycemic Status, Lipid Profile, Oxidative Stress, Inflammation, Growth Factor, Adiponectin, Sex Hormones and Anthropometric Indices in Women With Endometriosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Nutrition and Food Technology Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shahid Beheshti University of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Nutrition and Food Technology Institute</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>
        Quercetin is a polyphenol compound that possesses anti-inflammatory properties and can be&#xD;
        found in various food sources like apples, berries, cabbage, and onions. In Park et al.'s&#xD;
        study, it was discovered that quercetin led to a significant decrease in the proliferation of&#xD;
        endometriosis cells. Furthermore, quercetin also triggered apoptosis in endometriosis cells&#xD;
        in vitro and reduced the size of endometriosis lesions in vivo. Nevertheless, as of now,&#xD;
        there have been no studies conducted in Iran or worldwide that explore the effects of&#xD;
        quercetin supplementation on individuals with endometriosis. Hence, the aim of this study is&#xD;
        to investigate the impact of quercetin supplementation on factors such as glycemic status,&#xD;
        lipid profile, oxidative stress, inflammation, growth factors, adiponectin, sex hormones, and&#xD;
        anthropometric indicators in women suffering from endometriosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The participants in the study were randomly assigned to two groups: the intervention group&#xD;
        and the control group. The intervention group will receive two 500 mg quercetin tablets&#xD;
        daily, after breakfast and lunch, for twelve weeks. On the other hand, the control group will&#xD;
        be given a placebo. Blood samples will be collected before and after the intervention to&#xD;
        measure changes in blood lipid profile, fasting blood sugar, sex hormones (testosterone,&#xD;
        estrogen, progesterone), TNFα, IL-6, adiponectin, IGF1, HbA1C, SHBG, FSH, LH, and plasma&#xD;
        total antioxidant capacity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean serum TNF-alpha concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean serum IL-6 concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>Human Interleukin 6, IL-6 ELISA Kit</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean Serum FBS concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>Glucose Test Kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean HbA1C Serum</measure>
      <time_frame>12 weeks</time_frame>
      <description>Human Hemoglobin A1c (HbA1c) Assay Kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Serum Testosterone concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>The Testosterone ELISA Kits</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Serum Estrogen concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>The Total Estrogens ELISA Assay Kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Serum Adiponectin concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>Adiponectin Human ELISA Kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Serum IGF1 concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>IGF-1 ELISA Assay Kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Serum SHBG concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>liquid chromatography-tandem mass spectrometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Serum FSH concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>FSH (Human) ELISA Kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Serum LH concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>LH (Human) ELISA Kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Serum Progesterone concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>The Progesterone Enzyme Immunoassay Kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean plasma total antioxidant capacity concentration</measure>
      <time_frame>12 weeks</time_frame>
      <description>Total Antioxidant Capacity ELISA Kit</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Endometriosis</condition>
    <arm_group>
      <arm_group_label>Quercetin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The Placebogroup will receive Placebo tablets daily, after breakfast and lunch, for twelve weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Quercetin</intervention_name>
      <description>The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.</description>
      <arm_group_label>Quercetin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>The control group will receive two placebo daily, after breakfast and lunch, for twelve weeks.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Willing to cooperate and complete the informed consent form.&#xD;
  &#xD;
            -  Diagnosed endometriosis using laparoscopy and histopathological tests.&#xD;
  &#xD;
            -  In the age group of 18 to 40 years.&#xD;
  &#xD;
            -  Having a regular menstrual cycle.&#xD;
  &#xD;
            -  Having a body mass index between 18.5 and 30.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Using hormonal medications or intrauterine treatments for a minimum of three months&#xD;
               prior to collecting a sample.&#xD;
  &#xD;
            -  Having immune system disorders, persistent infections, diabetes, or any conditions&#xD;
               like polyps and fibroids within the uterine cavity.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ghazaleh Eslamian, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Nutrition and Food Technology Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ghazaleh Eslamian, PhD</last_name>
      <phone>+989122173918</phone>
      <email>gh_eslamian@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Nutrition and Food Technology Research Institute</name>
        <address>
          <city>Tehran</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ghazaleh Eslamian, PhD</last_name>
        <email>gh_eslamian@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <reference>
      <citation>Khorshidi M, Moini A, Alipoor E, Rezvan N, Gorgani-Firuzjaee S, Yaseri M, Hosseinzadeh-Attar MJ. The effects of quercetin supplementation on metabolic and hormonal parameters as well as plasma concentration and gene expression of resistin in overweight or obese women with polycystic ovary syndrome. Phytother Res. 2018 Nov;32(11):2282-2289. doi: 10.1002/ptr.6166. Epub 2018 Jul 30.</citation>
      <PMID>30062709</PMID>
    </reference>
    <reference>
      <citation>Rezvan N, Moini A, Gorgani-Firuzjaee S, Hosseinzadeh-Attar MJ. Oral Quercetin Supplementation Enhances Adiponectin Receptor Transcript Expression in Polycystic Ovary Syndrome Patients: A Randomized Placebo-Controlled Double-Blind Clinical Trial. Cell J. 2018 Jan;19(4):627-633. doi: 10.22074/cellj.2018.4577. Epub 2017 Nov 4.</citation>
      <PMID>29105398</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Nutrition and Food Technology Institute</investigator_affiliation>
      <investigator_full_name>Ghazaleh Eslamian</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Quercetin</keyword>
    <keyword>Endometriosis</keyword>
    <keyword>Inflammation</keyword>
    <keyword>Gonadal Steroid Hormones</keyword>
    <keyword>Anthropometric</keyword>
    <keyword>Adiponectin</keyword>
    <keyword>Growth factor</keyword>
    <keyword>Metabolic factors</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometriosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Quercetin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>One year after starting the study</ipd_time_frame>
    </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/NCT05983224
  org study id: 43003154
  nct id: NCT05983224
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Quercetin is a polyphenol compound that possesses anti-inflammatory properties and can be
        found in various food sources like apples, berries, cabbage, and onions. In Park et al.'s
        study, it was discovered that quercetin led to a significant decrease in the proliferation of
        endometriosis cells. Furthermore, quercetin also triggered apoptosis in endometriosis cells
        in vitro and reduced the size of endometriosis lesions in vivo. Nevertheless, as of now,
        there have been no studies conducted in Iran or worldwide that explore the effects of
        quercetin supplementation on individuals with endometriosis. Hence, the aim of this study is
        to investigate the impact of quercetin supplementation on factors such as glycemic status,
        lipid profile, oxidative stress, inflammation, growth factors, adiponectin, sex hormones, and
        anthropometric indicators in women suffering from endometriosis.
  The participants in the study were randomly assigned to two groups: the intervention group
        and the control group. The intervention group will receive two 500 mg quercetin tablets
        daily, after breakfast and lunch, for twelve weeks. On the other hand, the control group will
        be given a placebo. Blood samples will be collected before and after the intervention to
        measure changes in blood lipid profile, fasting blood sugar, sex hormones (testosterone,
        estrogen, progesterone), TNFα, IL-6, adiponectin, IGF1, HbA1C, SHBG, FSH, LH, and plasma
        total antioxidant capacity.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Mean serum TNF-alpha concentration
  time frame: 12 weeks
  description: Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit
  measure: Mean serum IL-6 concentration
  time frame: 12 weeks
  description: Human Interleukin 6, IL-6 ELISA Kit
  measure: Mean Serum FBS concentration
  time frame: 12 weeks
  description: Glucose Test Kit
  measure: Mean HbA1C Serum
  time frame: 12 weeks
  description: Human Hemoglobin A1c (HbA1c) Assay Kit
  measure: Mean Serum Testosterone concentration
  time frame: 12 weeks
  description: The Testosterone ELISA Kits
  measure: Mean Serum Estrogen concentration
  time frame: 12 weeks
  description: The Total Estrogens ELISA Assay Kit
  measure: Mean Serum Adiponectin concentration
  time frame: 12 weeks
  description: Adiponectin Human ELISA Kit
  measure: Mean Serum IGF1 concentration
  time frame: 12 weeks
  description: IGF-1 ELISA Assay Kit
  measure: Mean Serum SHBG concentration
  time frame: 12 weeks
  description: liquid chromatography-tandem mass spectrometry
  measure: Mean Serum FSH concentration
  time frame: 12 weeks
  description: FSH (Human) ELISA Kit
  measure: Mean Serum LH concentration
  time frame: 12 weeks
  description: LH (Human) ELISA Kit
  measure: Mean Serum Progesterone concentration
  time frame: 12 weeks
  description: The Progesterone Enzyme Immunoassay Kit
  measure: Mean plasma total antioxidant capacity concentration
  time frame: 12 weeks
  description: Total Antioxidant Capacity ELISA Kit
  arm group label: Quercetin
  arm group type: Experimental
  description: The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: The Placebogroup will receive Placebo tablets daily, after breakfast and lunch, for twelve weeks.
  intervention type: Dietary Supplement
  intervention name: Quercetin
  description: The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.
  arm group label: Quercetin
  intervention type: Other
  intervention name: Placebo
  description: The control group will receive two placebo daily, after breakfast and lunch, for twelve weeks.
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Ghazaleh Eslamian, PhD
  role: Principal Investigator
  affiliation: National Nutrition and Food Technology Research Institute
  last name: Ghazaleh Eslamian, PhD
  phone: +989122173918
  email: gh_eslamian@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Iran, Islamic Republic of
  citation: Khorshidi M, Moini A, Alipoor E, Rezvan N, Gorgani-Firuzjaee S, Yaseri M, Hosseinzadeh-Attar MJ. The effects of quercetin supplementation on metabolic and hormonal parameters as well as plasma concentration and gene expression of resistin in overweight or obese women with polycystic ovary syndrome. Phytother Res. 2018 Nov;32(11):2282-2289. doi: 10.1002/ptr.6166. Epub 2018 Jul 30.
  PMID: 30062709
  citation: Rezvan N, Moini A, Gorgani-Firuzjaee S, Hosseinzadeh-Attar MJ. Oral Quercetin Supplementation Enhances Adiponectin Receptor Transcript Expression in Polycystic Ovary Syndrome Patients: A Randomized Placebo-Controlled Double-Blind Clinical Trial. Cell J. 2018 Jan;19(4):627-633. doi: 10.22074/cellj.2018.4577. Epub 2017 Nov 4.
  PMID: 29105398
  responsible party type: Principal Investigator
  investigator affiliation: National Nutrition and Food Technology Institute
  investigator full name: Ghazaleh Eslamian
  investigator title: Principal Investigator
  mesh term: Endometriosis
  mesh term: Quercetin
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: One year after starting the study