<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/NCT01694056</url>
  </required_header>
  <id_info>
    <org_study_id>NL39991.081.12</org_study_id>
    <nct_id>NCT01694056</nct_id>
  </id_info>
  <brief_title>Soy Protein Intake and the Metabolic Syndrome</brief_title>
  <acronym>SOY</acronym>
  <official_title>Soy Protein Intake and the Metabolic Syndrome: Reducing Inflammation to Improve Insulin Resistance and Glucose Homeostasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alpro Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Soy protein has a high biological value, and contains several potential health-related&#xD;
      nutritional factors, i.e. its amino acids pattern, biological active peptides and non-protein&#xD;
      compounds such as isoflavones. In the field of obesity and blood lipids soy protein is&#xD;
      well-studied and appreciated; it improves circulating blood lipids and is associated with&#xD;
      weight reduction. The effect of soy on insulin resistance, glucose homeostasis and the&#xD;
      metabolic syndrome is less frequently studied. However, several molecular mechanisms of&#xD;
      action of soy protein make it a promising approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The primary objective of the present study is to evaluate the effect of a high soy&#xD;
      protein diet on insulin resistance and glycemic control in participants with characteristics&#xD;
      of the metabolic syndrome. Secondly, the present study will evaluate whether reduced&#xD;
      low-grade inflammation is a possible mechanism underlying the improvement in insulin&#xD;
      resistance and glucose homeostasis. Finally, it will be assessed whether soy protein has&#xD;
      beneficial effects on components of the metabolic syndrome, such as cardio-metabolic risk&#xD;
      factors, blood lipid profile, blood pressure and endothelial function, fat storage in the&#xD;
      liver and gene-expression in subcutaneous abdominal adipose tissue.&#xD;
&#xD;
      Study design: Single-blind, cross-over strictly-controlled dietary intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Insulin sensitivity is measured with an intravenous glucose tolerance test (IVGTT).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adipose tissue gene expression</measure>
    <time_frame>4 weeks</time_frame>
    <description>Adipose tissue samples will be collected for subsequent gene expression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipids</measure>
    <time_frame>4 weeks</time_frame>
    <description>Circulating triglycerides, free fatty acids (FFA), and HDL and total cholesterol will be measured in fasted blood samples, LDL will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation markers and adipokines</measure>
    <time_frame>4 weeks</time_frame>
    <description>For low-grade inflammation interleukins, tumor necrosis factor-α, C-reactive protein and adipokines will be measured in fasting blood samples. Furthermore, peripheral blood mononuclear cells (PBMC's) will be collected to measure expression of genes involved in lipid handling and inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardio-metabolic risk factors</measure>
    <time_frame>4 weeks</time_frame>
    <description>Blood pressure and macro vascular regional arterial stiffness will be assessed by Pulse Wave Analysis (PWA). Besides PWA, we will also measure markers for endothelial function in fasting blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic lipid content</measure>
    <time_frame>4 weeks</time_frame>
    <description>Hepatic lipid content The lipid content in liver will be quantified by proton magnetic resonance spectroscopy (1H -MRS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Metabolic Syndrome X</condition>
  <arm_group>
    <arm_group_label>Soy protein diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High mixed protein diet (20 en%) with 25gr of soy protein per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High mixed protein diet (20 en%)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Soy protein diet</intervention_name>
    <description>4 weeks high protein diet (20 en%) with 25gr of soy protein per day</description>
    <arm_group_label>Soy protein diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control diet</intervention_name>
    <description>4 weeks high mixed protein diet (20 en%)</description>
    <arm_group_label>Control diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  45-70 years&#xD;
&#xD;
          -  No menstrual cycle for ≥1 year&#xD;
&#xD;
          -  Stable body weight for ≥6 months (no weight gain/loss &gt; 3 kg)&#xD;
&#xD;
          -  Stable exercise habits during the last 6 months, and not participating in any vigorous&#xD;
             exercise program&#xD;
&#xD;
          -  Central obesity: waist circumference ≥80 cm&#xD;
&#xD;
        Plus any one of the following four factors:&#xD;
&#xD;
          -  Raised triglyceride level: ≥1.7 mmol/L;&#xD;
&#xD;
          -  Reduced high-density lipoprotein (HDL) cholesterol: &lt;1.29 mmol/L&#xD;
&#xD;
          -  Raised blood pressure: systolic blood pressure ≥135 mmHg or diastolic BP ≥85 mmHg or&#xD;
             use of blood pressure lowering medication&#xD;
&#xD;
          -  Raised fasting plasma glucose ≥ 5.6 mmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (Undiagnosed) Diabetes - but not impaired fasting glucose (IFG) and/or impaired&#xD;
             glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening&#xD;
&#xD;
          -  Active hearth disease, i.e. history of myocardial infarction, stroke or angina&#xD;
             pectoris&#xD;
&#xD;
          -  Active or a history of thyroid disease&#xD;
&#xD;
          -  Cancer or other malignancies in the past 5 years&#xD;
&#xD;
          -  Two sided ovariectomy&#xD;
&#xD;
          -  Drug use knowing to interfere with objectives of the study&#xD;
&#xD;
          -  oral corticosteroids, lipid-lowering drugs (statins)&#xD;
&#xD;
          -  anti-conceptive use (such as the pill or IUD)&#xD;
&#xD;
          -  hormone replacement therapy&#xD;
&#xD;
          -  long-term antibiotics use&#xD;
&#xD;
          -  Habitual intake of soy foods (&gt;1 soy food per week)&#xD;
&#xD;
          -  Isoflavone supplements&#xD;
&#xD;
          -  Vegetarian&#xD;
&#xD;
          -  Following, or have recently followed a (weight-loss) diet&#xD;
&#xD;
          -  Allergic to soy or dairy products&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Consuming more than 14 glasses of alcohol per week&#xD;
&#xD;
          -  Donated or intended to donate blood 2 months before till two months after the study&#xD;
&#xD;
          -  Participation in another biomedical study within 1 month before the first screening&#xD;
             visit&#xD;
&#xD;
          -  Not willing to be informed if deviations are found in blood samples&#xD;
&#xD;
          -  Contraindications to MRI scanning&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Mensink, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Departement of Human Nutrition, Wageningen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wageningen University</name>
      <address>
        <city>Wageningen</city>
        <zip>6703 HD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>January 3, 2013</last_update_submitted>
  <last_update_submitted_qc>January 3, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2013</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>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT01694056
org study id: NL39991.081.12
nct id: NCT01694056
lead sponsor: 
collaborator: 
has dmc: Yes
Soy protein has a high biological value, and contains several potential health-related
      nutritional factors, i.e. its amino acids pattern, biological active peptides and non-protein
      compounds such as isoflavones. In the field of obesity and blood lipids soy protein is
      well-studied and appreciated; it improves circulating blood lipids and is associated with
      weight reduction. The effect of soy on insulin resistance, glucose homeostasis and the
      metabolic syndrome is less frequently studied. However, several molecular mechanisms of
      action of soy protein make it a promising approach.
Objective: The primary objective of the present study is to evaluate the effect of a high soy
      protein diet on insulin resistance and glycemic control in participants with characteristics
      of the metabolic syndrome. Secondly, the present study will evaluate whether reduced
      low-grade inflammation is a possible mechanism underlying the improvement in insulin
      resistance and glucose homeostasis. Finally, it will be assessed whether soy protein has
      beneficial effects on components of the metabolic syndrome, such as cardio-metabolic risk
      factors, blood lipid profile, blood pressure and endothelial function, fat storage in the
      liver and gene-expression in subcutaneous abdominal adipose tissue.

      Study design: Single-blind, cross-over strictly-controlled dietary intervention.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Insulin sensitivity
time frame: 4 weeks
description: Insulin sensitivity is measured with an intravenous glucose tolerance test (IVGTT).
measure: Adipose tissue gene expression
time frame: 4 weeks
description: Adipose tissue samples will be collected for subsequent gene expression analysis.
measure: Blood lipids
time frame: 4 weeks
description: Circulating triglycerides, free fatty acids (FFA), and HDL and total cholesterol will be measured in fasted blood samples, LDL will be calculated.
measure: Inflammation markers and adipokines
time frame: 4 weeks
description: For low-grade inflammation interleukins, tumor necrosis factor-α, C-reactive protein and adipokines will be measured in fasting blood samples. Furthermore, peripheral blood mononuclear cells (PBMC's) will be collected to measure expression of genes involved in lipid handling and inflammation.
measure: Cardio-metabolic risk factors
time frame: 4 weeks
description: Blood pressure and macro vascular regional arterial stiffness will be assessed by Pulse Wave Analysis (PWA). Besides PWA, we will also measure markers for endothelial function in fasting blood samples.
measure: Hepatic lipid content
time frame: 4 weeks
description: Hepatic lipid content The lipid content in liver will be quantified by proton magnetic resonance spectroscopy (1H -MRS)
arm group label: Soy protein diet
arm group type: Experimental
description: High mixed protein diet (20 en%) with 25gr of soy protein per day
arm group label: Control diet
arm group type: Active Comparator
description: High mixed protein diet (20 en%)
intervention type: Other
intervention name: Soy protein diet
description: 4 weeks high protein diet (20 en%) with 25gr of soy protein per day
arm group label: Soy protein diet
intervention type: Other
intervention name: Control diet
description: 4 weeks high mixed protein diet (20 en%)
arm group label: Control diet
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marco Mensink, PhD
role: Study Chair
affiliation: Departement of Human Nutrition, Wageningen University
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome