<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/NCT03232970</url>
  </required_header>
  <id_info>
    <org_study_id>5170138</org_study_id>
    <nct_id>NCT03232970</nct_id>
  </id_info>
  <brief_title>Full Plate Diet Study</brief_title>
  <acronym>FPDCT</acronym>
  <official_title>Full Plate Diet Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ardmore Institute of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison between two groups, experimental and control. Experimental will undergo lectures&#xD;
      on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done&#xD;
      before and after the 3-months long program. Comparisons will be made pre and post and with&#xD;
      groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Full Plate Diet Clinical Trial is a study that will verify if the three months course is&#xD;
      sufficient to change diet behavior of the participants. Forty participants will be recruited&#xD;
      and then randomly assigned to one of two groups (20 in each group): The Experimental group&#xD;
      will attend one weekly session with instructions on how to increase fiber intake; Control&#xD;
      group will not have the intervention. The goal of the study is to see if the Full Plate Diet&#xD;
      program will improve blood measures of metabolic diseases and weight.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2018</start_date>
  <completion_date type="Actual">July 2, 2018</completion_date>
  <primary_completion_date type="Actual">July 2, 2018</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>
    <intervention_model_description>Randomized Control Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>3 months</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Fat</measure>
    <time_frame>3 months</time_frame>
    <description>Body Fat % measured by InBody 520 BIA machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipids</measure>
    <time_frame>3 months</time_frame>
    <description>Measure of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1C</measure>
    <time_frame>3 months</time_frame>
    <description>Glycated Hemoglobin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>FPD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will undergo three months of weekly lectures to incorporate more fiber in their diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FPD Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive all the assessments before, during and after the three months program period but will not attend the weekly lectures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Full Plate Diet</intervention_name>
    <description>12 weekly sessions on how to incorporate more fiber in the diet.</description>
    <arm_group_label>FPD group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any gender and age between 21-65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI between 25 to 35,&#xD;
&#xD;
          -  no debilitating disease,&#xD;
&#xD;
          -  no previous participation in the FPD program,&#xD;
&#xD;
          -  no allergies to beans&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Loma Linda University</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kim SJ, de Souza RJ, Choo VL, Ha V, Cozma AI, Chiavaroli L, Mirrahimi A, Blanco Mejia S, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ, Sievenpiper JL. Effects of dietary pulse consumption on body weight: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2016 May;103(5):1213-23. doi: 10.3945/ajcn.115.124677. Epub 2016 Mar 30.</citation>
    <PMID>27030531</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 30, 2019</last_update_submitted>
  <last_update_submitted_qc>July 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Hildemar Dos Santos, MD, DrPH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03232970
org study id: 5170138
nct id: NCT03232970
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison between two groups, experimental and control. Experimental will undergo lectures
      on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done
      before and after the 3-months long program. Comparisons will be made pre and post and with
      groups.
The Full Plate Diet Clinical Trial is a study that will verify if the three months course is
      sufficient to change diet behavior of the participants. Forty participants will be recruited
      and then randomly assigned to one of two groups (20 in each group): The Experimental group
      will attend one weekly session with instructions on how to increase fiber intake; Control
      group will not have the intervention. The goal of the study is to see if the Full Plate Diet
      program will improve blood measures of metabolic diseases and weight.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Control Trial
primary purpose: Prevention
masking: None (Open Label)
measure: Body Mass Index (BMI)
time frame: 3 months
description: weight and height will be combined to report BMI in kg/m^2
measure: Body Fat
time frame: 3 months
description: Body Fat % measured by InBody 520 BIA machine
measure: Lipids
time frame: 3 months
description: Measure of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides
measure: HbA1C
time frame: 3 months
description: Glycated Hemoglobin
arm group label: FPD group
arm group type: Experimental
description: This group will undergo three months of weekly lectures to incorporate more fiber in their diet.
arm group label: FPD Control group
arm group type: No Intervention
description: This group will receive all the assessments before, during and after the three months program period but will not attend the weekly lectures.
intervention type: Other
intervention name: Full Plate Diet
description: 12 weekly sessions on how to incorporate more fiber in the diet.
arm group label: FPD group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Kim SJ, de Souza RJ, Choo VL, Ha V, Cozma AI, Chiavaroli L, Mirrahimi A, Blanco Mejia S, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ, Sievenpiper JL. Effects of dietary pulse consumption on body weight: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2016 May;103(5):1213-23. doi: 10.3945/ajcn.115.124677. Epub 2016 Mar 30.
PMID: 27030531
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Hildemar Dos Santos, MD, DrPH
investigator title: Assistant Professor
sharing ipd: No