<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/NCT04458116</url>
  </required_header>
  <id_info>
    <org_study_id>Denise Mafra9</org_study_id>
    <nct_id>NCT04458116</nct_id>
  </id_info>
  <brief_title>Effects of Curcumin on Markers of Cardiovascular Risk in Patients With CAD</brief_title>
  <official_title>Curcumin Supplementation Effects on Markers of Cardiovascular Risk, Inflammation, Oxidative Stress and Functional Capacity in Patients With Coronary Arterial Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal Fluminense</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal Fluminense</source>
  <oversight_info>
    <has_dmc>No</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>
      - General Objective To evaluate the effects of curcumin supplementation on cardiovascular&#xD;
      risk markers, inflammation, oxidative stress and functional capacity in participants with&#xD;
      coronary artery disease.&#xD;
&#xD;
      Specific Objectives&#xD;
&#xD;
      Assess, before and after supplementation with turmeric:&#xD;
&#xD;
        -  The nutritional status of the participants;&#xD;
&#xD;
        -  Blood pressure;&#xD;
&#xD;
        -  Atherogenic risk;&#xD;
&#xD;
        -  The expression of transcription factors (Nrf2 and NF-kB), antioxidant enzymes (NQO1,&#xD;
           HO-1, sirtuin 1 (SIRT-1)), NLPR3 receptor, as well as the levels of inflammatory&#xD;
           cytokines (IL-6, tumor necrosis factor-alpha (TNF-α), protein C reactive (PCR), IL-1, IL&#xD;
           18) and vascular cell adhesion protein 1 (VCAM-1) and E-selectin adhesion molecules;&#xD;
&#xD;
        -  Routine biochemical parameters;&#xD;
&#xD;
        -  Lipid peroxidation and oxidized LDL;&#xD;
&#xD;
        -  The 6-minute walk test, the recovery heart rate and the chair lift test;&#xD;
&#xD;
        -  Modifiable risk factors before and after supplementation;&#xD;
&#xD;
        -  The comparison of all parameters between groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary Artery Disease (CAD) is the leading cause of death worldwide. CAD refers to the&#xD;
      pathological process of atherosclerosis that affects the coronary arteries, often leading to&#xD;
      obstruction by an atheromatous plaque. Oxidative stress is one of the most potent inducers of&#xD;
      vascular inflammation in atherogenesis. Reactive oxygen species (ROS) regulate through&#xD;
      nuclear factor kB (NF-kB), transcription factors and genes related to inflammation, thus,&#xD;
      activation of NF-kB by ROS in the atherosclerosis patient is associated with vascular&#xD;
      dysfunction and thus with inflammation and atherosclerosis. Recently, researchers have&#xD;
      discovered a transcription factor identified as nuclear factor-erythroid 2-related factor 2&#xD;
      (Nrf2) transcription factor, which is responsible for the expression of antioxidant response&#xD;
      element genes that can inhibit this pathway, thus providing cellular protection. Thus,&#xD;
      several nutritional strategies have been studied, including the use of curcumin, a chemical&#xD;
      compound of the class of curcumin produced by turmeric root (Curcuma longa). Turmeric is&#xD;
      capable of promoting the activation of nuclear factor-erythroid 2-related factor 2 (Nrf2)&#xD;
      transcription factor and inflammasome (NLPR3). These factors, in turn, are involved with the&#xD;
      activity of nuclear factor kappa-B (NF-kB), a transcription factor that increases the&#xD;
      synthesis of inflammatory cytokines. Thus, the present study aims to evaluate the effects of&#xD;
      turmeric supplementation on cardiovascular risk markers, inflammation, oxidative stress and&#xD;
      evaluation of functional capacity. Perspectives: This study aims to improve the inflammatory&#xD;
      and oxidative stress status of patients with CAD with the use of turmeric, and thus try to&#xD;
      reduce the risk factors related to the onset and progression of coronary artery disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 10, 2022</start_date>
  <completion_date type="Anticipated">November 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2022</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>Is a longitudinal randomized clinical study where participants will be randomized into two groups: Turmeric Group, in which participants will receive 1.5 grams of turmeric 95% curcumin (ACTIVE PHARMACEUTICA LTDA) for 1 month (3 capsules / day containing 500mg each for 4 weeks), and placebo group, where participants will receive capsules containing corn starch. Randomization will be done in blocks.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effects of curcumin supplementation on the expression of transcription factors</measure>
    <time_frame>4 months</time_frame>
    <description>Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The effects of curcumin supplementation on antioxidant enzymes.</measure>
    <time_frame>4 months</time_frame>
    <description>Get blood samples to evaluate the supplementation effects in antioxidants biomarkers glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1), NQO1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The effects of curcumin supplementation on inflammatory cytokines.</measure>
    <time_frame>4 months</time_frame>
    <description>Get blood samples to evaluate the supplementation effects on cytokines</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effects of curcumin supplementation on blood pressure</measure>
    <time_frame>4 months</time_frame>
    <description>Measurement of blood pressure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Oxidative Stress</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Tumeric Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants will receive capsules containing 1.5 grams of turmeric 95% curcumin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group.</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>will receive capsules containing corn starch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Curcumin</intervention_name>
    <description>Participants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks).</description>
    <arm_group_label>Placebo Group.</arm_group_label>
    <arm_group_label>Tumeric Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  with a previous diagnosis of coronary artery disease and / or altered myocardial&#xD;
             scintigraphy, both performed by a cardiologist.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  autoimmune and infectious diseases&#xD;
&#xD;
          -  pregnant and lactating women&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  AIDS;&#xD;
&#xD;
          -  participants using catabolic drugs, antioxidant vitamin supplements and habitual&#xD;
             intake of turmeric and turmeric.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Denise Mafra, PhD</last_name>
    <phone>5521985683003</phone>
    <email>dmafra30@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ludmila Cardozo, PhD</last_name>
    <email>ludmila.cardozo@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Denise Mafra</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>22260050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Curcumin</keyword>
  <keyword>Oxidative Stress</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary 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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04458116
org study id: Denise Mafra9
nct id: NCT04458116
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
- General Objective To evaluate the effects of curcumin supplementation on cardiovascular
      risk markers, inflammation, oxidative stress and functional capacity in participants with
      coronary artery disease.

      Specific Objectives

      Assess, before and after supplementation with turmeric:

        -  The nutritional status of the participants;

        -  Blood pressure;

        -  Atherogenic risk;

        -  The expression of transcription factors (Nrf2 and NF-kB), antioxidant enzymes (NQO1,
           HO-1, sirtuin 1 (SIRT-1)), NLPR3 receptor, as well as the levels of inflammatory
           cytokines (IL-6, tumor necrosis factor-alpha (TNF-α), protein C reactive (PCR), IL-1, IL
           18) and vascular cell adhesion protein 1 (VCAM-1) and E-selectin adhesion molecules;

        -  Routine biochemical parameters;

        -  Lipid peroxidation and oxidized LDL;

        -  The 6-minute walk test, the recovery heart rate and the chair lift test;

        -  Modifiable risk factors before and after supplementation;

        -  The comparison of all parameters between groups.
Coronary Artery Disease (CAD) is the leading cause of death worldwide. CAD refers to the
      pathological process of atherosclerosis that affects the coronary arteries, often leading to
      obstruction by an atheromatous plaque. Oxidative stress is one of the most potent inducers of
      vascular inflammation in atherogenesis. Reactive oxygen species (ROS) regulate through
      nuclear factor kB (NF-kB), transcription factors and genes related to inflammation, thus,
      activation of NF-kB by ROS in the atherosclerosis patient is associated with vascular
      dysfunction and thus with inflammation and atherosclerosis. Recently, researchers have
      discovered a transcription factor identified as nuclear factor-erythroid 2-related factor 2
      (Nrf2) transcription factor, which is responsible for the expression of antioxidant response
      element genes that can inhibit this pathway, thus providing cellular protection. Thus,
      several nutritional strategies have been studied, including the use of curcumin, a chemical
      compound of the class of curcumin produced by turmeric root (Curcuma longa). Turmeric is
      capable of promoting the activation of nuclear factor-erythroid 2-related factor 2 (Nrf2)
      transcription factor and inflammasome (NLPR3). These factors, in turn, are involved with the
      activity of nuclear factor kappa-B (NF-kB), a transcription factor that increases the
      synthesis of inflammatory cytokines. Thus, the present study aims to evaluate the effects of
      turmeric supplementation on cardiovascular risk markers, inflammation, oxidative stress and
      evaluation of functional capacity. Perspectives: This study aims to improve the inflammatory
      and oxidative stress status of patients with CAD with the use of turmeric, and thus try to
      reduce the risk factors related to the onset and progression of coronary artery disease.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Is a longitudinal randomized clinical study where participants will be randomized into two groups: Turmeric Group, in which participants will receive 1.5 grams of turmeric 95% curcumin (ACTIVE PHARMACEUTICA LTDA) for 1 month (3 capsules / day containing 500mg each for 4 weeks), and placebo group, where participants will receive capsules containing corn starch. Randomization will be done in blocks.
primary purpose: Health Services Research
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The effects of curcumin supplementation on the expression of transcription factors
time frame: 4 months
description: Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)
measure: The effects of curcumin supplementation on antioxidant enzymes.
time frame: 4 months
description: Get blood samples to evaluate the supplementation effects in antioxidants biomarkers glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1), NQO1
measure: The effects of curcumin supplementation on inflammatory cytokines.
time frame: 4 months
description: Get blood samples to evaluate the supplementation effects on cytokines
measure: The effects of curcumin supplementation on blood pressure
time frame: 4 months
description: Measurement of blood pressure
arm group label: Tumeric Group
arm group type: Experimental
description: participants will receive capsules containing 1.5 grams of turmeric 95% curcumin
arm group label: Placebo Group.
arm group type: Placebo Comparator
description: will receive capsules containing corn starch.
intervention type: Dietary Supplement
intervention name: Curcumin
description: Participants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks).
arm group label: Placebo Group.
arm group label: Tumeric Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Denise Mafra, PhD
phone: 5521985683003
email: dmafra30@gmail.com
last name: Ludmila Cardozo, PhD
email: ludmila.cardozo@gmail.com
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Inflammation
mesh term: Curcumin
sharing ipd: No