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/NCT05975866</url>
    </required_header>
    <id_info>
      <org_study_id>0410359181</org_study_id>
      <nct_id>NCT05975866</nct_id>
    </id_info>
    <brief_title>The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato</brief_title>
    <official_title>The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Nutrition and Food Technology Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to investigate The effects of an anti-inflammatory diet&#xD;
        with or without curcumin supplementation on anthropometric measurements, concentrations of&#xD;
        thyroid hormones, anti-TPO, and systemic inflammation in plasma and NFK-B in peripheral blood&#xD;
        mononuclear cells in patients with Hashimoto.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. Does prescribing an anti-inflammatory diet with or without curcumin supplementation&#xD;
             significantly affect the changes in anthropometric measurements (weight, body mass&#xD;
             index, BMI, waist circumference, waist-to-hip ratio) in patients with Hashimoto's&#xD;
             disease?&#xD;
  &#xD;
          2. Does prescribing an anti-inflammatory diet with or without curcumin supplementation&#xD;
             significantly affect the changes in the serum concentration of thyroid hormones (T3, T4,&#xD;
             TSH) in patients with Hashimoto's disease?&#xD;
  &#xD;
          3. Does prescribing an anti-inflammatory diet with or without curcumin supplementation&#xD;
             significantly affect the change of Anti-TPO concentration in patients with Hashimoto's&#xD;
             disease?&#xD;
  &#xD;
          4. Does prescribing an anti-inflammatory diet with or without curcumin supplementation&#xD;
             significantly affect the changes in systemic inflammation indicators (hs-CRP, IL-6) in&#xD;
             plasma and NF-κB in peripheral blood mononuclear cells in patients with Hashimoto's&#xD;
             disease?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 23, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 19, 2025</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>
      <intervention_model_description>The study subjects are Hashimoto's patients who, if they wish to participate in this research, a written consent form will be obtained from the patients at the beginning of the study. The patients will be classified according to age and sex. Then, using Stratified Block Randomization, patients will be placed in one of two intervention or placebo groups. The intervention will last 12 weeks, and the anti-inflammatory diet will be personalized based on each person's calorie intake. Patients will be asked to take one tablet with cold water daily (morning, noon, and night with the main meals). Also, the curcumin placebo in size, shape, color, appearance, smell, and dispensing cans of the drug will be similar to the curcumin supplement.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Before the start of the study, the set of cans containing the relevant capsules will be coded as A and B by someone other than the researcher so that the researcher does not know the type of capsule received by the patients. The cans containing the relevant capsules will be delivered to the patients on a monthly basis, and they will be asked to take one tablet with cold water every day (morning, noon, and night with the main meals). Also, the curcumin placebo will be similar to the curcumin supplement in terms of size, shape, color, appearance, smell, and drug distribution cans.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>IL6</measure>
      <time_frame>3 month</time_frame>
      <description>Interleukin 6</description>
    </primary_outcome>
    <primary_outcome>
      <measure>hs-Crp</measure>
      <time_frame>3 month</time_frame>
      <description>high-sensitivity C-reactive protein</description>
    </primary_outcome>
    <primary_outcome>
      <measure>NF-KB</measure>
      <time_frame>3 month</time_frame>
      <description>Nuclear factor kappa-light-chain-enhancer of activated B cells</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anti-tpo</measure>
      <time_frame>3 month</time_frame>
      <description>antithyroperoxidase</description>
    </primary_outcome>
    <primary_outcome>
      <measure>T4</measure>
      <time_frame>3 month</time_frame>
      <description>Thyroxine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>T3</measure>
      <time_frame>3 month</time_frame>
      <description>Triiodothyronine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>TSH</measure>
      <time_frame>3 month</time_frame>
      <description>Thyroid-stimulating hormone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>waist circumference</measure>
      <time_frame>3 month</time_frame>
      <description>waist circumference in Centimeter</description>
    </primary_outcome>
    <primary_outcome>
      <measure>hip circumference</measure>
      <time_frame>3 month</time_frame>
      <description>hip circumference in Centimeter</description>
    </primary_outcome>
    <primary_outcome>
      <measure>waist to hip ratio</measure>
      <time_frame>3 month</time_frame>
      <description>an Anthropometric index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>BMI</measure>
      <time_frame>3 month</time_frame>
      <description>Body Mass Index - Anthropometric index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total Cholestrol</measure>
      <time_frame>3 month</time_frame>
      <description>serum lipid profile</description>
    </primary_outcome>
    <primary_outcome>
      <measure>TG</measure>
      <time_frame>3 month</time_frame>
      <description>Triglyceride - serum lipid profile</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hb</measure>
      <time_frame>3 month</time_frame>
      <description>hemoglobin - Blood test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>hematocrit</measure>
      <time_frame>3 month</time_frame>
      <description>Blood test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>LDL</measure>
      <time_frame>3 month</time_frame>
      <description>low-density lipoprotein</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HDL</measure>
      <time_frame>3 month</time_frame>
      <description>high-density lipoprotein</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Thyroid Diseases</condition>
    <condition>Hypothyroidism</condition>
    <condition>Hashimoto Disease</condition>
    <arm_group>
      <arm_group_label>The group receiving anti-inflammatory diet with curcumin supplement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Implementation of an anti-inflammatory diet along with the daily consumption of three 500 mg curcumin capsules along with the main meals of breakfast, lunch, and dinner.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group receiving anti-inflammatory regimen with curcumin placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Implementation of an anti-inflammatory diet along with the daily consumption of three 500 mg placebo capsules of curcumin (microcrystalline cellulose) and the main meals of breakfast, lunch, and dinner.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>curcumin</intervention_name>
      <description>Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner</description>
      <arm_group_label>The group receiving anti-inflammatory diet with curcumin supplement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Anti-inflammatory diet</intervention_name>
      <description>The anti-inflammatory diet will be personalized based on each person's calorie intake in five meals. Achieving the goals of an anti-inflammatory diet by consuming only one type of food or following its principles in one meal is impossible and must be implemented consistently and regularly in a meal plan.</description>
      <arm_group_label>Group receiving anti-inflammatory regimen with curcumin placebo</arm_group_label>
      <arm_group_label>The group receiving anti-inflammatory diet with curcumin supplement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Having Hashimoto's thyroiditis Willingness to cooperate Body mass index between 35 and 18.5&#xD;
          TSH less than ten and without clinical symptoms Not taking levothyroxine tablets&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Pregnancy and breastfeeding kidney Diseases Follow non-routine weight loss diets for three&#xD;
          months before the start of the study × Taking slimming and fat-burning drugs, fiber powder&#xD;
          Mineral, vegetable, and fiber vitamin supplements&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Golbon Sohrab</name>
        <address>
          <city>Tehran</city>
          <state>National Nutrition And Food Technology Research Institute</state>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 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>Dr Azita Hekmatdoost</investigator_full_name>
      <investigator_title>MD-PHD of nutrition s science</investigator_title>
    </responsible_party>
    <keyword>Thyroid Diseases</keyword>
    <keyword>Hypothyroidism</keyword>
    <keyword>Hashimoto Disease</keyword>
    <keyword>Anti-inflammatory diet</keyword>
    <keyword>Curcumin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thyroid Diseases</mesh_term>
      <mesh_term>Hypothyroidism</mesh_term>
      <mesh_term>Hashimoto Disease</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Curcumin</mesh_term>
      <mesh_term>Anti-Inflammatory Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05975866
  org study id: 0410359181
  nct id: NCT05975866
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to investigate The effects of an anti-inflammatory diet
        with or without curcumin supplementation on anthropometric measurements, concentrations of
        thyroid hormones, anti-TPO, and systemic inflammation in plasma and NFK-B in peripheral blood
        mononuclear cells in patients with Hashimoto.
  
        The main questions it aims to answer are:
  
          1. Does prescribing an anti-inflammatory diet with or without curcumin supplementation
             significantly affect the changes in anthropometric measurements (weight, body mass
             index, BMI, waist circumference, waist-to-hip ratio) in patients with Hashimoto's
             disease?
  
          2. Does prescribing an anti-inflammatory diet with or without curcumin supplementation
             significantly affect the changes in the serum concentration of thyroid hormones (T3, T4,
             TSH) in patients with Hashimoto's disease?
  
          3. Does prescribing an anti-inflammatory diet with or without curcumin supplementation
             significantly affect the change of Anti-TPO concentration in patients with Hashimoto's
             disease?
  
          4. Does prescribing an anti-inflammatory diet with or without curcumin supplementation
             significantly affect the changes in systemic inflammation indicators (hs-CRP, IL-6) in
             plasma and NF-κB in peripheral blood mononuclear cells in patients with Hashimoto's
             disease?
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study subjects are Hashimoto's patients who, if they wish to participate in this research, a written consent form will be obtained from the patients at the beginning of the study. The patients will be classified according to age and sex. Then, using Stratified Block Randomization, patients will be placed in one of two intervention or placebo groups. The intervention will last 12 weeks, and the anti-inflammatory diet will be personalized based on each person's calorie intake. Patients will be asked to take one tablet with cold water daily (morning, noon, and night with the main meals). Also, the curcumin placebo in size, shape, color, appearance, smell, and dispensing cans of the drug will be similar to the curcumin supplement.
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Before the start of the study, the set of cans containing the relevant capsules will be coded as A and B by someone other than the researcher so that the researcher does not know the type of capsule received by the patients. The cans containing the relevant capsules will be delivered to the patients on a monthly basis, and they will be asked to take one tablet with cold water every day (morning, noon, and night with the main meals). Also, the curcumin placebo will be similar to the curcumin supplement in terms of size, shape, color, appearance, smell, and drug distribution cans.
  measure: IL6
  time frame: 3 month
  description: Interleukin 6
  measure: hs-Crp
  time frame: 3 month
  description: high-sensitivity C-reactive protein
  measure: NF-KB
  time frame: 3 month
  description: Nuclear factor kappa-light-chain-enhancer of activated B cells
  measure: Anti-tpo
  time frame: 3 month
  description: antithyroperoxidase
  measure: T4
  time frame: 3 month
  description: Thyroxine
  measure: T3
  time frame: 3 month
  description: Triiodothyronine
  measure: TSH
  time frame: 3 month
  description: Thyroid-stimulating hormone
  measure: waist circumference
  time frame: 3 month
  description: waist circumference in Centimeter
  measure: hip circumference
  time frame: 3 month
  description: hip circumference in Centimeter
  measure: waist to hip ratio
  time frame: 3 month
  description: an Anthropometric index
  measure: BMI
  time frame: 3 month
  description: Body Mass Index - Anthropometric index
  measure: Total Cholestrol
  time frame: 3 month
  description: serum lipid profile
  measure: TG
  time frame: 3 month
  description: Triglyceride - serum lipid profile
  measure: Hb
  time frame: 3 month
  description: hemoglobin - Blood test
  measure: hematocrit
  time frame: 3 month
  description: Blood test
  measure: LDL
  time frame: 3 month
  description: low-density lipoprotein
  measure: HDL
  time frame: 3 month
  description: high-density lipoprotein
  arm group label: The group receiving anti-inflammatory diet with curcumin supplement
  arm group type: Experimental
  description: Implementation of an anti-inflammatory diet along with the daily consumption of three 500 mg curcumin capsules along with the main meals of breakfast, lunch, and dinner.
  arm group label: Group receiving anti-inflammatory regimen with curcumin placebo
  arm group type: Placebo Comparator
  description: Implementation of an anti-inflammatory diet along with the daily consumption of three 500 mg placebo capsules of curcumin (microcrystalline cellulose) and the main meals of breakfast, lunch, and dinner.
  intervention type: Dietary Supplement
  intervention name: curcumin
  description: Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner
  arm group label: The group receiving anti-inflammatory diet with curcumin supplement
  intervention type: Behavioral
  intervention name: Anti-inflammatory diet
  description: The anti-inflammatory diet will be personalized based on each person's calorie intake in five meals. Achieving the goals of an anti-inflammatory diet by consuming only one type of food or following its principles in one meal is impossible and must be implemented consistently and regularly in a meal plan.
  arm group label: Group receiving anti-inflammatory regimen with curcumin placebo
  arm group label: The group receiving anti-inflammatory diet with curcumin supplement
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: National Nutrition and Food Technology Institute
  investigator full name: Dr Azita Hekmatdoost
  investigator title: MD-PHD of nutrition s science
  mesh term: Thyroid Diseases
  mesh term: Hypothyroidism
  mesh term: Hashimoto Disease
  mesh term: Inflammation
  mesh term: Curcumin
  mesh term: Anti-Inflammatory Agents
  sharing ipd: No