<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/NCT03828955</url>
  </required_header>
  <id_info>
    <org_study_id>CS15123</org_study_id>
    <nct_id>NCT03828955</nct_id>
  </id_info>
  <brief_title>Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect in Humans</brief_title>
  <official_title>Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect by Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chung Shan Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chung Shan Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is the report to assess supplementation with soybean peptides on blood pressure among&#xD;
      people with mild hypertension. Overall, soybean peptide consumption for 8 weeks could&#xD;
      successfully reduce mean diastolic and systolic BP through the suppression of&#xD;
      Angiotensin-converting enzyme (ACE) linked to downstream suppression of angiotensin II&#xD;
      formation, which further decreases the sympathetic outflow that leads to hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is the report to assess supplementation with soybean peptides on blood pressure among&#xD;
      people with mild hypertension. Thirty subjects with systolic blood pressure (SBP) between 120&#xD;
      and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg were randomized&#xD;
      to ingest 2 bags of soybean peptides or placebo per day for 8 weeks of a stage.&#xD;
      Anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical&#xD;
      markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride&#xD;
      (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT) were examined every&#xD;
      four weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">October 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The soy bean peptides anti-hypertensive measure blood pressure (SBP and DBP)</measure>
    <time_frame>8 weeks</time_frame>
    <description>values chang of systolbbic and diastolic BPs between before to after 8 weeks</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Soybean peptides</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive two bags soybean peptides per day for 8 weeks of a stage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects receive two bags starch placebo of similar appearance per day for 8 weeks of a stage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soybean peptides</intervention_name>
    <description>Subjects receive two bags soybean peptides per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hipline and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every four weeks.</description>
    <arm_group_label>Soybean peptides</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects receive two bags of starch placebo of similar appearance per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hipline, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible subjects were untreated hypertensive men or women aged between 20 and 80&#xD;
             years old with SBP between 120 and 159 mmHg and/or DBP between 80 and 99 mmHg as&#xD;
             measured in a sitting position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects were excluded if they had a history of major cardiovascular disease or severe&#xD;
             liver dysfunction;&#xD;
&#xD;
          -  Diastolic blood pressure ≥ 100 mmHg or Systolic blood pressure ≥ 160 mmHg;&#xD;
&#xD;
          -  Alcoholic;&#xD;
&#xD;
          -  US-controlled diabetics;&#xD;
&#xD;
          -  Stoke in past one year;&#xD;
&#xD;
          -  Mental diseases or melancholia;&#xD;
&#xD;
          -  Pregnancy or breast-feeding a child;&#xD;
&#xD;
          -  Renal dysfunction;&#xD;
&#xD;
          -  Allergic to Soybean peptides.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>You-Cheng Mr Shen, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chung Shan Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chung Shan Medical University</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Lo WM, Li-Chan EC. Angiotensin I converting enzyme inhibitory peptides from in vitro pepsin-pancreatin digestion of soy protein. J Agric Food Chem. 2005 May 4;53(9):3369-76. doi: 10.1021/jf048174d.</citation>
    <PMID>15853374</PMID>
  </reference>
  <reference>
    <citation>Rizzello CG, Cassone A, Di Cagno R, Gobbetti M. Synthesis of angiotensin I-converting enzyme (ACE)-inhibitory peptides and gamma-aminobutyric acid (GABA) during sourdough fermentation by selected lactic acid bacteria. J Agric Food Chem. 2008 Aug 27;56(16):6936-43. doi: 10.1021/jf800512u. Epub 2008 Jul 16.</citation>
    <PMID>18627167</PMID>
  </reference>
  <reference>
    <citation>Yoshiji H, Kuriyama S, Fukui H. Angiotensin-I-converting enzyme inhibitors may be an alternative anti-angiogenic strategy in the treatment of liver fibrosis and hepatocellular carcinoma. Possible role of vascular endothelial growth factor. Tumour Biol. 2002 Nov-Dec;23(6):348-56. doi: 10.1159/000069792.</citation>
    <PMID>12677092</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 20, 2021</last_update_submitted>
  <last_update_submitted_qc>May 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chung Shan Medical University</investigator_affiliation>
    <investigator_full_name>You-Cheng Shen</investigator_full_name>
    <investigator_title>School of Health Diet and Industry Managment</investigator_title>
  </responsible_party>
  <keyword>soybean peptides</keyword>
  <keyword>clinical trial</keyword>
  <keyword>blood preesure</keyword>
  <keyword>SBP</keyword>
  <keyword>DBP</keyword>
  <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/NCT03828955
org study id: CS15123
nct id: NCT03828955
lead sponsor: 
has dmc: Yes
This is the report to assess supplementation with soybean peptides on blood pressure among
      people with mild hypertension. Overall, soybean peptide consumption for 8 weeks could
      successfully reduce mean diastolic and systolic BP through the suppression of
      Angiotensin-converting enzyme (ACE) linked to downstream suppression of angiotensin II
      formation, which further decreases the sympathetic outflow that leads to hypertension.
This is the report to assess supplementation with soybean peptides on blood pressure among
      people with mild hypertension. Thirty subjects with systolic blood pressure (SBP) between 120
      and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg were randomized
      to ingest 2 bags of soybean peptides or placebo per day for 8 weeks of a stage.
      Anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical
      markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride
      (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT) were examined every
      four weeks.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The soy bean peptides anti-hypertensive measure blood pressure (SBP and DBP)
time frame: 8 weeks
description: values chang of systolbbic and diastolic BPs between before to after 8 weeks
arm group label: Soybean peptides
arm group type: Experimental
description: Subjects receive two bags soybean peptides per day for 8 weeks of a stage.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects receive two bags starch placebo of similar appearance per day for 8 weeks of a stage.
intervention type: Dietary Supplement
intervention name: Soybean peptides
description: Subjects receive two bags soybean peptides per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hipline and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every four weeks.
arm group label: Soybean peptides
intervention type: Dietary Supplement
intervention name: Placebo
description: Subjects receive two bags of starch placebo of similar appearance per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hipline, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: You-Cheng Mr Shen, Ph.D.
role: Principal Investigator
affiliation: Chung Shan Medical University
facility: 
country: Taiwan
citation: Lo WM, Li-Chan EC. Angiotensin I converting enzyme inhibitory peptides from in vitro pepsin-pancreatin digestion of soy protein. J Agric Food Chem. 2005 May 4;53(9):3369-76. doi: 10.1021/jf048174d.
PMID: 15853374
citation: Rizzello CG, Cassone A, Di Cagno R, Gobbetti M. Synthesis of angiotensin I-converting enzyme (ACE)-inhibitory peptides and gamma-aminobutyric acid (GABA) during sourdough fermentation by selected lactic acid bacteria. J Agric Food Chem. 2008 Aug 27;56(16):6936-43. doi: 10.1021/jf800512u. Epub 2008 Jul 16.
PMID: 18627167
citation: Yoshiji H, Kuriyama S, Fukui H. Angiotensin-I-converting enzyme inhibitors may be an alternative anti-angiogenic strategy in the treatment of liver fibrosis and hepatocellular carcinoma. Possible role of vascular endothelial growth factor. Tumour Biol. 2002 Nov-Dec;23(6):348-56. doi: 10.1159/000069792.
PMID: 12677092
responsible party type: Principal Investigator
investigator affiliation: Chung Shan Medical University
investigator full name: You-Cheng Shen
investigator title: School of Health Diet and Industry Managment
mesh term: Hypertension