<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/NCT02191644</url>
  </required_header>
  <id_info>
    <org_study_id>PBMC_Lp-PLA2_metabolite</org_study_id>
    <nct_id>NCT02191644</nct_id>
  </id_info>
  <brief_title>Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes</brief_title>
  <official_title>Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes</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>
      This study examined whether dietary-induced reductions in lipoprotein-associated&#xD;
      phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma&#xD;
      affected metabolic profiles in PBMCs and plasma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2&#xD;
      diabetes were randomly assigned to a control group (normal diet with refined rice) or a&#xD;
      whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary&#xD;
      intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4%&#xD;
      of protein-derived energy and approximately 3% of fat-derived energy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lp-PLA2 Activity in Plasma</measure>
    <time_frame>Change from baseline in Lp-PLA2 at 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lp-PLA2 Activity in PBMC</measure>
    <time_frame>Change from baseline in Lp-PLA2 at 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PBMC metabolites</measure>
    <time_frame>Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>LDL particle size</measure>
    <time_frame>Changes from baseline in LDL particle size at 12 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Prediabetes</condition>
  <condition>Type-2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Refined rice</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole grains and legumes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary intervention-refined rice</intervention_name>
    <description>Subjects in the control group maintained the usual refined-rice diet.</description>
    <arm_group_label>Refined rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary intervention-whole grains and legumes</intervention_name>
    <description>Subjects in the whole-grain group replaced refined rice with a mix of 1/3 legumes, 1/3 barley, and 1/3 wild rice three times per day, and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.</description>
    <arm_group_label>Whole grains and legumes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects who had IFG (100≤ fasting glucose &lt;126 mg/dL)&#xD;
&#xD;
          -  or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current and/or past history of cardiovascular disease including angina&#xD;
&#xD;
          -  liver or kidney dysfunction&#xD;
&#xD;
          -  thyroid or pituitary disease&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  taking medications or supplements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Ho Lee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yonsei University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yonsei University</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>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</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/NCT02191644
org study id: PBMC_Lp-PLA2_metabolite
nct id: NCT02191644
lead sponsor: 
has dmc: Yes
This study examined whether dietary-induced reductions in lipoprotein-associated
      phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma
      affected metabolic profiles in PBMCs and plasma.
Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2
      diabetes were randomly assigned to a control group (normal diet with refined rice) or a
      whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary
      intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4%
      of protein-derived energy and approximately 3% of fat-derived energy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Lp-PLA2 Activity in Plasma
time frame: Change from baseline in Lp-PLA2 at 12 weeks
measure: Lp-PLA2 Activity in PBMC
time frame: Change from baseline in Lp-PLA2 at 12 weeks
measure: PBMC metabolites
time frame: Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)
measure: LDL particle size
time frame: Changes from baseline in LDL particle size at 12 weeks
arm group label: Refined rice
arm group type: Placebo Comparator
arm group label: Whole grains and legumes
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Dietary intervention-refined rice
description: Subjects in the control group maintained the usual refined-rice diet.
arm group label: Refined rice
intervention type: Dietary Supplement
intervention name: Dietary intervention-whole grains and legumes
description: Subjects in the whole-grain group replaced refined rice with a mix of 1/3 legumes, 1/3 barley, and 1/3 wild rice three times per day, and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.
arm group label: Whole grains and legumes
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jong Ho Lee, PhD
role: Principal Investigator
affiliation: Yonsei University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
mesh term: Glucose Intolerance