<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/NCT01667939</url>
  </required_header>
  <id_info>
    <org_study_id>HMPMP05/06/09</org_study_id>
    <nct_id>NCT01667939</nct_id>
  </id_info>
  <brief_title>A Supervised Nutritional Program in Pregnancies and NF-κB Expression in Placenta</brief_title>
  <official_title>A Supervised Nutritional Program in Pregnancies Diminish the NF-κB Expression in Placenta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Materno-Perinatal Hospital of the State of Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Council of Science and Technology, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Secretariat of Public Education (SEP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Materno-Perinatal Hospital of the State of Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nuclear factor kappa B (NF-κB) pathway and oxidative stress participate in endothelial&#xD;
      dysfunction, which is one of the causes of preeclampsia. Among the human antioxidant&#xD;
      mechanisms there are the enzymes catalase (CAT), glutathione peroxidase (GPx) and superoxide&#xD;
      dismutase (SOD). Our aim was to measure NF-κB and oxidative stress in pregnant women&#xD;
      submitted to an individualized diet during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity during pregnancy is associated with exaggerated metabolic adaptation, endothelial&#xD;
      dysfunction and an increased risk of adverse pregnancy outcomes, including preeclampsia, a&#xD;
      major cause of maternal and fetal morbidity and mortality characterized by increased blood&#xD;
      pressure, proteinuria and edema, which affects approximately 3% to 7% of all pregnant women.&#xD;
      Other risk factors, besides obesity, that increase the likelihood of developing preeclampsia&#xD;
      include chronic hypertension, and diabetes mellitus.&#xD;
&#xD;
      Reactive oxygen species (ROS) [superoxide anions (•O2-), hydrogen peroxide (H2O2) and&#xD;
      hydroxyl radicals (•OH)],5 interact with proteins, nucleic acids and lipids and in a process&#xD;
      called lipid peroxidation (LPO), can cause severe cell and tissue damage. There is current&#xD;
      evidence that ROS are common activators of nuclear factor-kappa B (NF-κB), a factor that&#xD;
      initiates a systemic inflammatory process by promoting the synthesis of cytokines,&#xD;
      interleukin (IL)-6, IL-8, monocyte chemotactic protein-1 (MCP-1) and expression of&#xD;
      intercellular adhesion molecule (ICAM-1).&#xD;
&#xD;
      To maintain balance of the oxidative state, the human body possesses intracellular&#xD;
      antioxidant enzyme systems, including superoxide dismutase (SOD, glutathione peroxidase&#xD;
      (GPx), and catalase (CAT), which is located mainly in peroxisomes and cytoplasm of the cell.&#xD;
&#xD;
      The epidemiology of preeclampsia, which is more common among poor women, had previously&#xD;
      suggested that nutrients may be involved in the disorder, unfortunately, the nutritional data&#xD;
      obtained from women with the syndrome has been poorly defined.&#xD;
&#xD;
      The objective of this paper was to provide an overview of the biological plausibility and&#xD;
      potential mechanisms underlying associations among maternal nutrition, oxidative stress in&#xD;
      placenta and the risk of preeclampsia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">December 2010</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Placental expression of NF-κB</measure>
    <time_frame>two years</time_frame>
    <description>measure of gene expression by real time PCR</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Dietary Habits</condition>
  <arm_group>
    <arm_group_label>pregnancy diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Eating Index (HEI) in supervised pregnancies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>unsupervised pregnancy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>women attending the obstetrics unit who did not follow a supervised diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Eating Index (HEI) in supervised pregnancies</intervention_name>
    <description>Dietetic treatment was calculated according to height, weeks of gestation and weight, considering an energy intake of 30 kcal/kg of expected weight, distributing the resulting energy according to the percentage of macronutrients' adequation (55-65% carbohydrates, 10-20% fat and the remainder as proteins).16 On each nutritional visit, 24 hour dietary recall was done and analyzed using NutriKcal®VO software in order to evaluate the Healthy Eating Index (HEI), which is commonly employed to assess pregnant women's dietary adequacy (on a scale from 0-100), through the consumption of 12 components of food groups described previously. An improvement in diet was considered when the initial HEI score improved more than one point during the next nutritional assessment.</description>
    <arm_group_label>pregnancy diet</arm_group_label>
    <other_name>NutriKcal®VO software</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in their first trimester of pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple pregnancies&#xD;
&#xD;
          -  prior history of chronic-metabolic diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hugo Mendieta Zeron, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Materno-Perinatal Hospital &quot;Monica Pretelini&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Materno-Perinatal Hospital &quot;Mónica Pretelini&quot;</name>
      <address>
        <city>Toluca</city>
        <zip>50130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Materno-Perinatal Hospital of the State of Mexico</investigator_affiliation>
    <investigator_full_name>Hugo Mendieta Zeron</investigator_full_name>
    <investigator_title>General Internal Medicine, Researcher</investigator_title>
  </responsible_party>
  <keyword>adequacy</keyword>
  <keyword>diet</keyword>
  <keyword>pregnancy</keyword>
  <!-- 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/NCT01667939
org study id: HMPMP05/06/09
nct id: NCT01667939
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Nuclear factor kappa B (NF-κB) pathway and oxidative stress participate in endothelial
      dysfunction, which is one of the causes of preeclampsia. Among the human antioxidant
      mechanisms there are the enzymes catalase (CAT), glutathione peroxidase (GPx) and superoxide
      dismutase (SOD). Our aim was to measure NF-κB and oxidative stress in pregnant women
      submitted to an individualized diet during pregnancy.
Obesity during pregnancy is associated with exaggerated metabolic adaptation, endothelial
      dysfunction and an increased risk of adverse pregnancy outcomes, including preeclampsia, a
      major cause of maternal and fetal morbidity and mortality characterized by increased blood
      pressure, proteinuria and edema, which affects approximately 3% to 7% of all pregnant women.
      Other risk factors, besides obesity, that increase the likelihood of developing preeclampsia
      include chronic hypertension, and diabetes mellitus.

      Reactive oxygen species (ROS) [superoxide anions (•O2-), hydrogen peroxide (H2O2) and
      hydroxyl radicals (•OH)],5 interact with proteins, nucleic acids and lipids and in a process
      called lipid peroxidation (LPO), can cause severe cell and tissue damage. There is current
      evidence that ROS are common activators of nuclear factor-kappa B (NF-κB), a factor that
      initiates a systemic inflammatory process by promoting the synthesis of cytokines,
      interleukin (IL)-6, IL-8, monocyte chemotactic protein-1 (MCP-1) and expression of
      intercellular adhesion molecule (ICAM-1).

      To maintain balance of the oxidative state, the human body possesses intracellular
      antioxidant enzyme systems, including superoxide dismutase (SOD, glutathione peroxidase
      (GPx), and catalase (CAT), which is located mainly in peroxisomes and cytoplasm of the cell.

      The epidemiology of preeclampsia, which is more common among poor women, had previously
      suggested that nutrients may be involved in the disorder, unfortunately, the nutritional data
      obtained from women with the syndrome has been poorly defined.

      The objective of this paper was to provide an overview of the biological plausibility and
      potential mechanisms underlying associations among maternal nutrition, oxidative stress in
      placenta and the risk of preeclampsia.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Placental expression of NF-κB
time frame: two years
description: measure of gene expression by real time PCR
arm group label: pregnancy diet
arm group type: Experimental
description: Healthy Eating Index (HEI) in supervised pregnancies
arm group label: unsupervised pregnancy
arm group type: No Intervention
description: women attending the obstetrics unit who did not follow a supervised diet
intervention type: Behavioral
intervention name: Healthy Eating Index (HEI) in supervised pregnancies
description: Dietetic treatment was calculated according to height, weeks of gestation and weight, considering an energy intake of 30 kcal/kg of expected weight, distributing the resulting energy according to the percentage of macronutrients' adequation (55-65% carbohydrates, 10-20% fat and the remainder as proteins).16 On each nutritional visit, 24 hour dietary recall was done and analyzed using NutriKcal®VO software in order to evaluate the Healthy Eating Index (HEI), which is commonly employed to assess pregnant women's dietary adequacy (on a scale from 0-100), through the consumption of 12 components of food groups described previously. An improvement in diet was considered when the initial HEI score improved more than one point during the next nutritional assessment.
arm group label: pregnancy diet
other name: NutriKcal®VO software
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 36 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hugo Mendieta Zeron, PhD
role: Principal Investigator
affiliation: Materno-Perinatal Hospital "Monica Pretelini"
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Materno-Perinatal Hospital of the State of Mexico
investigator full name: Hugo Mendieta Zeron
investigator title: General Internal Medicine, Researcher