<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/NCT03008785</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 40622414.9.0000.5152</org_study_id>
    <nct_id>NCT03008785</nct_id>
  </id_info>
  <brief_title>Effect of Isoflavone Supplementation Associated With Physical Exercise in the Health Parameters of Postmenopausal Women</brief_title>
  <official_title>Effect of Isoflavone Supplementation Associated With Physical Exercise on Blood Pressure, Lipic and Inflamatory Profile, Body Composition and Hydratation and Climacteric Symptoms in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Uberlandia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Uberlandia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluate if 10 weeks of mixed exercise combined with isoflavones could have&#xD;
      greater effects on climacteric symptoms, body composition and hydratation, lipidic and&#xD;
      inflamatory profile than exercise alone in postmenopausal women. the participants will be&#xD;
      randomly assigned to the group: placebo and exercise or 100mg of isoflavone and exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several endocrine metabolic changes occur during the climacteric period, due to the lack of&#xD;
      estrogen and also by the aging process and some studies show that ingestion of isoflavones by&#xD;
      postmenopausal women may have benefits. Theoretically the isoflavone potentiate the effects&#xD;
      obtained during exercise&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>Change in blood pressure in 10 weeks intervention</time_frame>
    <description>Evaluate change in blood pressure through ambulatory 24-hour blood pressure monitoring used before the begin of intervention and after 10 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Climateric Symptoms (Kupperman-Blatt Index)</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>Evaluate the intensity of climateric symptoms using the Kupperman-Blatt Index questionnaire. Consists of 11 questions in which the symptoms are given numerical values according to their intensity .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Climateric Symptoms (Cervantes Scale)</measure>
    <time_frame>before the begin the intervention and after 10 weeks</time_frame>
    <description>Evaluate the intensity of climateric symptoms using the Cervantes Scale questionnaire. Composed of 31 questions distributed in four domains and 6 possibilities of answer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Climateric Symptoms (Menopause Rating Scale)</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>Evaluate the intensity of climateric symptoms using the Menopause Rating Scale questionnaire. Composed of eleven questions, with five possible answers, Symptoms divided into somatovegetative, psychological and urogenital domains may be classified as absent, mild, moderate, severe and very severe. With a general score ranging from 0 to 55 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile (enzymatic colorimetric method)</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>The concentrations in mg/dL of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol and uric acid will be made through the enzymatic colorimetric method. The glucose will be analyzed by the enzymatic method and the glycated hemoglobin A1c by the turbidimetry method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Human cytokines (Flow Cytometry)</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>Measurement in pg/mL of the production of human cytokines (IL-8, IL-1β, IL-6, TNF ( tumor necrosis factor), IL-10 and IL-12p70) in serum samples will be performed by the flow cytometry (FACSCantoII BDTM) Human Inflammatory Cytokines Kit &quot;(BD ™ Cytometric Bead Array (CBA), BD Biosciences, San Jose, CA, USA) according to the manufacturer's instructions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antioxidant capacity</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>The total antioxidant capacity will be evaluated in plasma and saliva using the FRAP (Ferric-Absorbing Ability of Plasma) methodology (Benzie and Strain, 1999).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total protein</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>The determination of the total salivary and plasma protein will be performed by the Bradfort method (Bradford, 1976) adapted for microplate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>Bioelectrical impedance (Biodynamics, model 450c, EUA) will be used to determine absolute and relative extracellular mass and body cell mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase Angle</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>Phase angle in degrees (o) was calculated using the equation (Reactance/Resistance)&#xD;
*(180/л) using a values obtained on bioelectrical impedance (Biodynamics, model 450c, EUA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress (SOD, Catalase and TBARS activity)</measure>
    <time_frame>before and after 10 weeks</time_frame>
    <description>The enzyme superoxide dismutase (SOD) will be dosed from the auto oxidation capacity of pyrogallol, a process dependent on the superoxide radical (Fernandes et al., 2011). . Catalase activity in saliva will be determined based on the decrease in absorbance of hydrogen peroxide (H2O2) (Aebi, 1984). Thiobarbituric acid reactive substances (TBARS) will be detected by the Yagi method (Yagi, 1998).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Bloodpressure</condition>
  <arm_group>
    <arm_group_label>group isoflavone and exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The isoflavone group received daily 100mg of isoflavones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group placebo and exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The placebo group received 100mg containing starch of corn.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise</intervention_name>
    <description>The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.</description>
    <arm_group_label>group isoflavone and exercise</arm_group_label>
    <arm_group_label>group placebo and exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>isoflavone</intervention_name>
    <description>Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).</description>
    <arm_group_label>group isoflavone and exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Daily supplementation in 1 capsule per day containing starch of corn.</description>
    <arm_group_label>group placebo and exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy postmenopausal woman&#xD;
&#xD;
          -  to be able to practice exercises on treadmill and weight exercises&#xD;
&#xD;
          -  without physical complications that prevent the execution of physical exercises&#xD;
&#xD;
          -  have no history of cardiovascular disease, diabetes, renal pathologies or hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  use hormone therapy or isoflavone&#xD;
&#xD;
          -  use drugs that interfere with lipid and antihypertensive metabolism&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guilherme Puga, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Uberlandia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guilherme Morais Puga</name>
      <address>
        <city>Uberlandia</city>
        <state>Minas Gerais</state>
        <zip>38400-678</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Acharjee S, Zhou JR, Elajami TK, Welty FK. Effect of soy nuts and equol status on blood pressure, lipids and inflammation in postmenopausal women stratified by metabolic syndrome status. Metabolism. 2015 Feb;64(2):236-43. doi: 10.1016/j.metabol.2014.09.005. Epub 2014 Oct 5.</citation>
    <PMID>25441251</PMID>
  </reference>
  <results_reference>
    <citation>Lebon J, Riesco E, Tessier D, Dionne IJ. Additive effects of isoflavones and exercise training on inflammatory cytokines and body composition in overweight and obese postmenopausal women: a randomized controlled trial. Menopause. 2014 Aug;21(8):869-75. doi: 10.1097/GME.0000000000000177.</citation>
    <PMID>24378766</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Uberlandia</investigator_affiliation>
    <investigator_full_name>Juliene Gonçalves Costa</investigator_full_name>
    <investigator_title>Guilherme Morais Puga PhD</investigator_title>
  </responsible_party>
  <keyword>isoflavone</keyword>
  <keyword>blood pressure</keyword>
  <keyword>climateric symptoms</keyword>
  <keyword>exercise</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03008785
org study id: CAAE: 40622414.9.0000.5152
nct id: NCT03008785
lead sponsor: 
has dmc: No
This study evaluate if 10 weeks of mixed exercise combined with isoflavones could have
      greater effects on climacteric symptoms, body composition and hydratation, lipidic and
      inflamatory profile than exercise alone in postmenopausal women. the participants will be
      randomly assigned to the group: placebo and exercise or 100mg of isoflavone and exercise.
Several endocrine metabolic changes occur during the climacteric period, due to the lack of
      estrogen and also by the aging process and some studies show that ingestion of isoflavones by
      postmenopausal women may have benefits. Theoretically the isoflavone potentiate the effects
      obtained during exercise
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change in blood pressure
time frame: Change in blood pressure in 10 weeks intervention
description: Evaluate change in blood pressure through ambulatory 24-hour blood pressure monitoring used before the begin of intervention and after 10 weeks.
measure: Climateric Symptoms (Kupperman-Blatt Index)
time frame: before and after 10 weeks
description: Evaluate the intensity of climateric symptoms using the Kupperman-Blatt Index questionnaire. Consists of 11 questions in which the symptoms are given numerical values according to their intensity .
measure: Climateric Symptoms (Cervantes Scale)
time frame: before the begin the intervention and after 10 weeks
description: Evaluate the intensity of climateric symptoms using the Cervantes Scale questionnaire. Composed of 31 questions distributed in four domains and 6 possibilities of answer.
measure: Climateric Symptoms (Menopause Rating Scale)
time frame: before and after 10 weeks
description: Evaluate the intensity of climateric symptoms using the Menopause Rating Scale questionnaire. Composed of eleven questions, with five possible answers, Symptoms divided into somatovegetative, psychological and urogenital domains may be classified as absent, mild, moderate, severe and very severe. With a general score ranging from 0 to 55 points
measure: Lipid profile (enzymatic colorimetric method)
time frame: before and after 10 weeks
description: The concentrations in mg/dL of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol and uric acid will be made through the enzymatic colorimetric method. The glucose will be analyzed by the enzymatic method and the glycated hemoglobin A1c by the turbidimetry method.
measure: Human cytokines (Flow Cytometry)
time frame: before and after 10 weeks
description: Measurement in pg/mL of the production of human cytokines (IL-8, IL-1β, IL-6, TNF ( tumor necrosis factor), IL-10 and IL-12p70) in serum samples will be performed by the flow cytometry (FACSCantoII BDTM) Human Inflammatory Cytokines Kit "(BD ™ Cytometric Bead Array (CBA), BD Biosciences, San Jose, CA, USA) according to the manufacturer's instructions.
measure: Antioxidant capacity
time frame: before and after 10 weeks
description: The total antioxidant capacity will be evaluated in plasma and saliva using the FRAP (Ferric-Absorbing Ability of Plasma) methodology (Benzie and Strain, 1999).
measure: Total protein
time frame: before and after 10 weeks
description: The determination of the total salivary and plasma protein will be performed by the Bradfort method (Bradford, 1976) adapted for microplate
measure: Body Composition
time frame: before and after 10 weeks
description: Bioelectrical impedance (Biodynamics, model 450c, EUA) will be used to determine absolute and relative extracellular mass and body cell mass.
measure: Phase Angle
time frame: before and after 10 weeks
description: Phase angle in degrees (o) was calculated using the equation (Reactance/Resistance)
*(180/л) using a values obtained on bioelectrical impedance (Biodynamics, model 450c, EUA)
measure: Oxidative stress (SOD, Catalase and TBARS activity)
time frame: before and after 10 weeks
description: The enzyme superoxide dismutase (SOD) will be dosed from the auto oxidation capacity of pyrogallol, a process dependent on the superoxide radical (Fernandes et al., 2011). . Catalase activity in saliva will be determined based on the decrease in absorbance of hydrogen peroxide (H2O2) (Aebi, 1984). Thiobarbituric acid reactive substances (TBARS) will be detected by the Yagi method (Yagi, 1998).
arm group label: group isoflavone and exercise
arm group type: Experimental
description: The isoflavone group received daily 100mg of isoflavones.
arm group label: group placebo and exercise
arm group type: Experimental
description: The placebo group received 100mg containing starch of corn.
intervention type: Other
intervention name: exercise
description: The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.
arm group label: group isoflavone and exercise
arm group label: group placebo and exercise
intervention type: Other
intervention name: isoflavone
description: Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).
arm group label: group isoflavone and exercise
intervention type: Other
intervention name: Placebo
description: Daily supplementation in 1 capsule per day containing starch of corn.
arm group label: group placebo and exercise
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guilherme Puga, PhD
role: Principal Investigator
affiliation: Federal University of Uberlandia
facility: 
country: Brazil
citation: Acharjee S, Zhou JR, Elajami TK, Welty FK. Effect of soy nuts and equol status on blood pressure, lipids and inflammation in postmenopausal women stratified by metabolic syndrome status. Metabolism. 2015 Feb;64(2):236-43. doi: 10.1016/j.metabol.2014.09.005. Epub 2014 Oct 5.
PMID: 25441251
citation: Lebon J, Riesco E, Tessier D, Dionne IJ. Additive effects of isoflavones and exercise training on inflammatory cytokines and body composition in overweight and obese postmenopausal women: a randomized controlled trial. Menopause. 2014 Aug;21(8):869-75. doi: 10.1097/GME.0000000000000177.
PMID: 24378766
responsible party type: Principal Investigator
investigator affiliation: Federal University of Uberlandia
investigator full name: Juliene Gonçalves Costa
investigator title: Guilherme Morais Puga PhD
sharing ipd: Undecided