<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/NCT04476160</url>
  </required_header>
  <id_info>
    <org_study_id>R-2018-785-108</org_study_id>
    <nct_id>NCT04476160</nct_id>
  </id_info>
  <brief_title>Effectiveness of Cinnamon on Insulin Resistance ( ECIRCCOS ) December 1, 2019</brief_title>
  <acronym>ECIRCCOS</acronym>
  <official_title>Effectiveness of Cinnamon on Insulin Resistance and Corporate Composition of Obese Schoolchildren</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coordinación de Investigación en Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Infantil de Mexico Federico Gomez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Coordinación de Investigación en Salud, Mexico</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>
      Childhood obesity is one of the most serious public health problems of the 21st century. It&#xD;
      is considered that if there are no changes in prevention and treatment strategies there will&#xD;
      be an increase to 70 million obese children by 2025. Of the only pharmacological treatments&#xD;
      accepted at this age to improve insulin resistance is metformin, but it can condition&#xD;
      gastrointestinal, muscular and hepatic adverse events. Cinnamon is an alternative therapy,&#xD;
      which due to its high concentrations of polyphenols, improves insulin resistance by&#xD;
      decreasing the proinflammatory environment that occurs in this group of patients, and unlike&#xD;
      metformin with less frequent adverse events. The effectiveness of cinnamon has been&#xD;
      demonstrated by decreasing insulin resistance in the adult population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Controlled clinical trial, 100 children aged 10 to 15 years with obesity Body Mass Index&#xD;
      (BMI&gt; 2 SD) will be selected. Children and parents who agree to participate will be measured&#xD;
      anthropometry (weight, height, BMI, body fat) and Tanner stage. Once the 100 children have&#xD;
      been selected and registered, a determination will be made after 8 hours of fasting leptin,&#xD;
      ghrelin, insulin, lipid profile, liver function tests, creatinine and cinnamic acid.&#xD;
      Subsequently they will be randomly assigned to a group that receives the intervention with&#xD;
      cinnamon 3000mg / day, or placebo; Both groups will receive diet and physical activity&#xD;
      recommendations according to the World Health Organization (WHO) guidelines. They will be&#xD;
      followed for 16 weeks. During this period, patients will be contacted weekly to confirm the&#xD;
      consumption of the capsules and interrogation of adverse effects such as dyspepsia,&#xD;
      gastrointestinal disturbances and headache. They will be scheduled monthly for capsule&#xD;
      counting and interrogation of adverse effects. At the end of the 16-week follow-up,&#xD;
      anthropometry, fasting after 8 hours of leptin, ghrelin, insulin lipid profile, liver&#xD;
      function tests, creatinine and cinnamic acid will be performed.&#xD;
&#xD;
      Statistical analysis: Shapiro Wilk test will be applied to the variables with quantitative&#xD;
      measurement scale to identify the type of distribution; in the case of parametric&#xD;
      distribution, the data with averages and standard deviation will be presented, in case of&#xD;
      presenting non-parametric distribution, medium and minimum and maximum values will be used.&#xD;
      In the case of qualitative variables, they will be expressed with percentages and simple&#xD;
      frequencies. Baseline characteristics will be compared between the two groups with t-Student&#xD;
      or U-Mann Whitney according to the type of distribution of the variables. To evaluate the&#xD;
      effect of the intervention, body fat deltas and biochemical measurements will be calculated&#xD;
      by subtracting the final value (after 16 weeks of intervention) from the initial (baseline)&#xD;
      value and statistical significance will be evaluated using comparisons between groups with&#xD;
      paired t- or Wilcoxon. Covariance analysis control of confounding variables (ANCOVA) will be&#xD;
      carried out.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 12, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 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>homeostatic model assessment (HOMA) index</measure>
    <time_frame>16 weeks</time_frame>
    <description>resistence insulin is evaluated for fasting glucose and insulin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appetite hormone (ghrelin [pg/ml])</measure>
    <time_frame>16 weeks</time_frame>
    <description>Change in fasting serum ghrelin from baseline to the end of intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appetite hormone (leptin [ng/ml])</measure>
    <time_frame>16 weeks</time_frame>
    <description>Change in fasting serum leptin from baseline to the end of intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>16 weeks</time_frame>
    <description>change in BMI from baseline to the end of intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obesity, Childhood</condition>
  <condition>Insulin Resistance</condition>
  <condition>Insulin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Cinnamon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, children will receive an intervention with 3000mg / day cinnamon along with diet and physical activity recommendations according to the WHO guidelines. They will be followed for 16 weeks. During this period, patients will be contacted weekly to corroborate the consumption of the capsules and interrogation of adverse effects such as dyspepsia, gastrointestinal disturbances and headache. They will be scheduled monthly for capsule counting and interrogation of adverse effects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group, children will receive a placebo intervention along with diet and physical activity recommendations according to the WHO guidelines. They will be followed for 16 weeks. During this period, patients will be contacted weekly to corroborate the consumption of the capsules and interrogation of adverse effects such as dyspepsia, gastrointestinal disturbances and headache. They will be scheduled monthly for capsule counting and interrogation of adverse effects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cinnamon</intervention_name>
    <description>children recipe 3 grams by day of cinnamon</description>
    <arm_group_label>Cinnamon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obesity (BMI &gt; 95 percentile )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  treatment with insulin or Metformin&#xD;
&#xD;
          -  genetic or endocrine obesity&#xD;
&#xD;
          -  routine consumption of cinnamon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessie Nallelly Zurita Cruz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Coordinación de Investigación en Salud, México</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Castuera Martinez</last_name>
    <phone>525556276900</phone>
    <phone_ext>21218</phone_ext>
    <email>carla_martinez@imss.gob.mx</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Study Officials</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Unit of research in Medical Nutricion, Pediatric Hospital CMN &quot;Siglo XXI&quot; , Instituto Mexicano del Seguro Social</name>
      <address>
        <city>Mexico</city>
        <state>México City</state>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessie Zurita Cruz</last_name>
      <phone>5554194513</phone>
      <email>zuritaj@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Mexicano del Seguro Social</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Juana Serret, MsC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mardia Lopez-Alarcon, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lourdes Barbosa-Cortes, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 12, 2019</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Coordinación de Investigación en Salud, Mexico</investigator_affiliation>
    <investigator_full_name>Jessie Nallelly Zurita Cruz</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>Insulin Resistance</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT04476160
org study id: R-2018-785-108
nct id: NCT04476160
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Childhood obesity is one of the most serious public health problems of the 21st century. It
      is considered that if there are no changes in prevention and treatment strategies there will
      be an increase to 70 million obese children by 2025. Of the only pharmacological treatments
      accepted at this age to improve insulin resistance is metformin, but it can condition
      gastrointestinal, muscular and hepatic adverse events. Cinnamon is an alternative therapy,
      which due to its high concentrations of polyphenols, improves insulin resistance by
      decreasing the proinflammatory environment that occurs in this group of patients, and unlike
      metformin with less frequent adverse events. The effectiveness of cinnamon has been
      demonstrated by decreasing insulin resistance in the adult population.
Controlled clinical trial, 100 children aged 10 to 15 years with obesity Body Mass Index
      (BMI> 2 SD) will be selected. Children and parents who agree to participate will be measured
      anthropometry (weight, height, BMI, body fat) and Tanner stage. Once the 100 children have
      been selected and registered, a determination will be made after 8 hours of fasting leptin,
      ghrelin, insulin, lipid profile, liver function tests, creatinine and cinnamic acid.
      Subsequently they will be randomly assigned to a group that receives the intervention with
      cinnamon 3000mg / day, or placebo; Both groups will receive diet and physical activity
      recommendations according to the World Health Organization (WHO) guidelines. They will be
      followed for 16 weeks. During this period, patients will be contacted weekly to confirm the
      consumption of the capsules and interrogation of adverse effects such as dyspepsia,
      gastrointestinal disturbances and headache. They will be scheduled monthly for capsule
      counting and interrogation of adverse effects. At the end of the 16-week follow-up,
      anthropometry, fasting after 8 hours of leptin, ghrelin, insulin lipid profile, liver
      function tests, creatinine and cinnamic acid will be performed.

      Statistical analysis: Shapiro Wilk test will be applied to the variables with quantitative
      measurement scale to identify the type of distribution; in the case of parametric
      distribution, the data with averages and standard deviation will be presented, in case of
      presenting non-parametric distribution, medium and minimum and maximum values will be used.
      In the case of qualitative variables, they will be expressed with percentages and simple
      frequencies. Baseline characteristics will be compared between the two groups with t-Student
      or U-Mann Whitney according to the type of distribution of the variables. To evaluate the
      effect of the intervention, body fat deltas and biochemical measurements will be calculated
      by subtracting the final value (after 16 weeks of intervention) from the initial (baseline)
      value and statistical significance will be evaluated using comparisons between groups with
      paired t- or Wilcoxon. Covariance analysis control of confounding variables (ANCOVA) will be
      carried out.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: homeostatic model assessment (HOMA) index
time frame: 16 weeks
description: resistence insulin is evaluated for fasting glucose and insulin
measure: Appetite hormone (ghrelin [pg/ml])
time frame: 16 weeks
description: Change in fasting serum ghrelin from baseline to the end of intervention
measure: Appetite hormone (leptin [ng/ml])
time frame: 16 weeks
description: Change in fasting serum leptin from baseline to the end of intervention
measure: Body mass index (BMI)
time frame: 16 weeks
description: change in BMI from baseline to the end of intervention
arm group label: Cinnamon
arm group type: Experimental
description: In this group, children will receive an intervention with 3000mg / day cinnamon along with diet and physical activity recommendations according to the WHO guidelines. They will be followed for 16 weeks. During this period, patients will be contacted weekly to corroborate the consumption of the capsules and interrogation of adverse effects such as dyspepsia, gastrointestinal disturbances and headache. They will be scheduled monthly for capsule counting and interrogation of adverse effects.
arm group label: Control
arm group type: No Intervention
description: In this group, children will receive a placebo intervention along with diet and physical activity recommendations according to the WHO guidelines. They will be followed for 16 weeks. During this period, patients will be contacted weekly to corroborate the consumption of the capsules and interrogation of adverse effects such as dyspepsia, gastrointestinal disturbances and headache. They will be scheduled monthly for capsule counting and interrogation of adverse effects.
intervention type: Dietary Supplement
intervention name: Cinnamon
description: children recipe 3 grams by day of cinnamon
arm group label: Cinnamon
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Jessie Nallelly Zurita Cruz
role: Principal Investigator
affiliation: Coordinación de Investigación en Salud, México
last name: Castuera Martinez
phone: 525556276900
phone ext: 21218
email: carla_martinez@imss.gob.mx
last name: Study Officials
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
investigator: 
investigator: 
investigator: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Coordinación de Investigación en Salud, Mexico
investigator full name: Jessie Nallelly Zurita Cruz
investigator title: principal investigator
mesh term: Insulin Resistance
mesh term: Pediatric Obesity