<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/NCT01674491</url>
  </required_header>
  <id_info>
    <org_study_id>BPS_201106</org_study_id>
    <nct_id>NCT01674491</nct_id>
  </id_info>
  <brief_title>Effects of Black Soy Peptide Supplementation on Blood Pressure</brief_title>
  <official_title>Effects of Black Soy Peptide Supplementation on Blood Pressure and Oxidative Stress:A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Black soy peptides have been shown to possess properties that may decrease blood pressure. To&#xD;
      examine the effects of black soy peptides supplementation on blood pressure and oxidative&#xD;
      stress in subjects with pre-hypertension or stage I hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial participants included men and women aged 30 to 65 years who had an average systolic&#xD;
      blood pressure (SBP) between 130 to 159 mmHg, average diastolic blood pressure (DBP) between&#xD;
      80 to 99 mmHg, or both, based on an average of six measurements during two screening visits.&#xD;
      Participants were supplied with 84 pouches of placebo (casein) or black soy peptide (3&#xD;
      pouches/day) at 0-week and at 4-week visits. Test group subjects received pouches containing&#xD;
      black soy peptides (4.5 g/day total soy peptides for 8 weeks). The control group received&#xD;
      pouches containing casein that had a similar appearance to the black soy peptide tablet.&#xD;
      During the intervention, we instructed study participants to continue their current food&#xD;
      intake patterns and lifestyles so that total energy intake and energy expenditure would be&#xD;
      constant during the course of trial. Participants brought back unconsumed pouches at their 4-&#xD;
      and 8-week follow-up visits. The dietitian counted the number of returned pouches, and we&#xD;
      used this to assess the participants' adherence to their assigned intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 3</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in Systolic blood pressure at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Diastolic blood pressure at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in plasma malondialdehyde at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in Urinary 8-epi-prostaglandin F2 at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in Renin at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in angiotensin-converting enzyme at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>4.5g/day black soy peptide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4.5 g/day, 8weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>similar appearance to the black soy peptide tablet, 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>black soy peptide</intervention_name>
    <description>black soy peptide: 4.5g/day for 8 weeks</description>
    <arm_group_label>4.5g/day black soy peptide</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Average systolic blood pressure (SBP) between 130 to 159 mmHg&#xD;
&#xD;
          -  Average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an&#xD;
             average of six measurements during two screening visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous diagnosed clinical hypertension&#xD;
&#xD;
          -  Self-reported use of anti-hypertensive medication&#xD;
&#xD;
          -  Abnormal liver or renal function&#xD;
&#xD;
          -  History of cardiovascular disease, cancer, thyroid or pituitary disease, or any other&#xD;
             serious life-threatening illness that required regular medical treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Ho Lee, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yonsei University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Clinical Nutrigenetics/Nutrigenomic</name>
      <address>
        <city>Seoul</city>
        <zip>120-749</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT01674491
org study id: BPS_201106
nct id: NCT01674491
lead sponsor: 
has dmc: Yes
Black soy peptides have been shown to possess properties that may decrease blood pressure. To
      examine the effects of black soy peptides supplementation on blood pressure and oxidative
      stress in subjects with pre-hypertension or stage I hypertension.
Trial participants included men and women aged 30 to 65 years who had an average systolic
      blood pressure (SBP) between 130 to 159 mmHg, average diastolic blood pressure (DBP) between
      80 to 99 mmHg, or both, based on an average of six measurements during two screening visits.
      Participants were supplied with 84 pouches of placebo (casein) or black soy peptide (3
      pouches/day) at 0-week and at 4-week visits. Test group subjects received pouches containing
      black soy peptides (4.5 g/day total soy peptides for 8 weeks). The control group received
      pouches containing casein that had a similar appearance to the black soy peptide tablet.
      During the intervention, we instructed study participants to continue their current food
      intake patterns and lifestyles so that total energy intake and energy expenditure would be
      constant during the course of trial. Participants brought back unconsumed pouches at their 4-
      and 8-week follow-up visits. The dietitian counted the number of returned pouches, and we
      used this to assess the participants' adherence to their assigned intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: change from baseline in Systolic blood pressure at 8 weeks
time frame: 8 weeks
measure: Change from baseline in Diastolic blood pressure at 8 weeks
time frame: 8 weeks
measure: change from baseline in plasma malondialdehyde at 8 weeks
time frame: 8 weeks
measure: change from baseline in Urinary 8-epi-prostaglandin F2 at 8 weeks
time frame: 8 weeks
measure: change from baseline in Renin at 8 weeks
time frame: 8 weeks
measure: Change from baseline in angiotensin-converting enzyme at 8 weeks
time frame: 8 weeks
arm group label: 4.5g/day black soy peptide
arm group type: Experimental
description: 4.5 g/day, 8weeks
arm group label: placebo
arm group type: Placebo Comparator
description: similar appearance to the black soy peptide tablet, 8 weeks
intervention type: Dietary Supplement
intervention name: black soy peptide
description: black soy peptide: 4.5g/day for 8 weeks
arm group label: 4.5g/day black soy peptide
arm group label: placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jong Ho Lee, Ph.D
role: Principal Investigator
affiliation: Yonsei University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension