<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/NCT03773029</url>
  </required_header>
  <id_info>
    <org_study_id>1397.247</org_study_id>
    <nct_id>NCT03773029</nct_id>
  </id_info>
  <brief_title>The Effects of Isoflavones on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients</brief_title>
  <official_title>Effects of Isoflavones on Cardiovascular Disease Risk Factors, Bone Metabolism Markers, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this double-blind randomized clinical trial is to determine the effects of&#xD;
      isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum&#xD;
      concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis&#xD;
      patients. Forty-four patients from shafa clinic and Dr.najafi's clinic will randomly assign&#xD;
      to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg&#xD;
      soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive&#xD;
      identical placebo. At the baseline and the end of the study,7 ml blood will be collected from&#xD;
      each patient after a 12-14-hours fasting and serum concentrations of Lp (a), MDA, hs-CRP,&#xD;
      sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH,&#xD;
      triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine,&#xD;
      pentosidine, glucose, albumin, calcium and phosphorous will be measured. Furthermore, blood&#xD;
      pressure measurements will be performed twice with a ten-minute interval between testing&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lp (a)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of lipoprotein-a</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MDA</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of malondialdehyde</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hs-CRP</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of high sensitivity c-reactive protein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sICAM-1</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of Soluble intercellular adhesion molecule-1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>bone alkaline phosphatase</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of bone alkaline phosphatase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>osteocalcin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of osteocalcin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>N-telopeptide</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of N-telopeptide</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Osteoprotegerin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of Osteoprotegerin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RANKL</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand</description>
  </primary_outcome>
  <primary_outcome>
    <measure>triglyceride</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of triglyceride</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total cholesterol</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of total cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HDL-C</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of High-density lipoprotein cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LDL-C</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of low-density lipoprotein cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sVCAM-1</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of Soluble vascular adhesion molecule-1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>E-selectin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of E-selectin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>albumin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>calcium</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of calcium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>phosphorous</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of phosphorous</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iPTH</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum concentrations of Intact parathyroid hormone</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">47</enrollment>
  <condition>Peritoneal Dialysis Patients</condition>
  <arm_group>
    <arm_group_label>isoflavone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 mg soy isoflavone (as 2 capsules)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 capsules of placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>soy isoflavone</intervention_name>
    <description>100 mg soy isoflavone (as 2 capsules)</description>
    <arm_group_label>isoflavone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>2 capsules of placebo</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        infections inflammatory diseases; liver diseases; past medical history of cancer receiving&#xD;
        glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant&#xD;
        consumption of soy or foods containing soy in the diet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>zahra yari</last_name>
    <phone>+982122357484</phone>
    <email>zahrayari_nut@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Nutrition and Food Technology Research Institute</name>
      <address>
        <city>Tehran</city>
        <state>Iran (the Islamic Republic Of)</state>
        <zip>1981619573</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zahra Yari</last_name>
      <phone>+982122357484</phone>
      <email>zahrayari_nut@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</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>zahra yari</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03773029
org study id: 1397.247
nct id: NCT03773029
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this double-blind randomized clinical trial is to determine the effects of
      isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum
      concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis
      patients. Forty-four patients from shafa clinic and Dr.najafi's clinic will randomly assign
      to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg
      soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive
      identical placebo. At the baseline and the end of the study,7 ml blood will be collected from
      each patient after a 12-14-hours fasting and serum concentrations of Lp (a), MDA, hs-CRP,
      sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH,
      triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine,
      pentosidine, glucose, albumin, calcium and phosphorous will be measured. Furthermore, blood
      pressure measurements will be performed twice with a ten-minute interval between testing
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Lp (a)
time frame: 8 weeks
description: Serum concentrations of lipoprotein-a
measure: MDA
time frame: 8 weeks
description: Serum concentrations of malondialdehyde
measure: hs-CRP
time frame: 8 weeks
description: Serum concentrations of high sensitivity c-reactive protein
measure: sICAM-1
time frame: 8 weeks
description: Serum concentrations of Soluble intercellular adhesion molecule-1
measure: bone alkaline phosphatase
time frame: 8 weeks
description: Serum concentrations of bone alkaline phosphatase
measure: osteocalcin
time frame: 8 weeks
description: Serum concentrations of osteocalcin
measure: N-telopeptide
time frame: 8 weeks
description: Serum concentrations of N-telopeptide
measure: Osteoprotegerin
time frame: 8 weeks
description: Serum concentrations of Osteoprotegerin
measure: RANKL
time frame: 8 weeks
description: Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
measure: triglyceride
time frame: 8 weeks
description: Serum concentrations of triglyceride
measure: total cholesterol
time frame: 8 weeks
description: Serum concentrations of total cholesterol
measure: HDL-C
time frame: 8 weeks
description: Serum concentrations of High-density lipoprotein cholesterol
measure: LDL-C
time frame: 8 weeks
description: Serum concentrations of low-density lipoprotein cholesterol
measure: sVCAM-1
time frame: 8 weeks
description: Serum concentrations of Soluble vascular adhesion molecule-1
measure: E-selectin
time frame: 8 weeks
description: Serum concentrations of E-selectin
measure: albumin
time frame: 8 weeks
description: Serum concentrations of albumin
measure: calcium
time frame: 8 weeks
description: Serum concentrations of calcium
measure: phosphorous
time frame: 8 weeks
description: Serum concentrations of phosphorous
measure: iPTH
time frame: 8 weeks
description: Serum concentrations of Intact parathyroid hormone
arm group label: isoflavone
arm group type: Active Comparator
description: 100 mg soy isoflavone (as 2 capsules)
arm group label: control
arm group type: Placebo Comparator
description: 2 capsules of placebo
intervention type: Dietary Supplement
intervention name: soy isoflavone
description: 100 mg soy isoflavone (as 2 capsules)
arm group label: isoflavone
intervention type: Other
intervention name: placebo
description: 2 capsules of placebo
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: zahra yari
phone: +982122357484
email: zahrayari_nut@yahoo.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: National Nutrition and Food Technology Institute
investigator full name: zahra yari
investigator title: Principal Investigator