<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/NCT03295188</url>
  </required_header>
  <id_info>
    <org_study_id>Pls2017-01</org_study_id>
    <nct_id>NCT03295188</nct_id>
  </id_info>
  <brief_title>Effects of Plasmalogen on Obese Subjects</brief_title>
  <official_title>A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Japanese Plasmalogen Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Japanese Plasmalogen Society</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects&#xD;
      of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen&#xD;
      in obese subjects aged 20-75 years old.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2017</start_date>
  <completion_date type="Actual">August 22, 2018</completion_date>
  <primary_completion_date type="Actual">August 22, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Profile of Mood States 2nd Edition (POMS 2)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Psychological rating scale to assess transient feelings and mood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist diameter</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood levels of plasmalogen</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Athens Insomnia Scale (AIS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-assessment psychometric tool to quantify sleep difficulty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two 0.5 mg plasmalogen capsules per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two placebo capsules containing no plasmalogen per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Plasmalogen</intervention_name>
    <description>Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Group takes two placebo capsules per day for 12 weeks.</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to provide informed consent to participate in the study&#xD;
&#xD;
          -  BMI ≥ 25 ㎏/㎡&#xD;
&#xD;
          -  HbA1C ≺ 8% without antidiabetic medication in the previous 3 months&#xD;
&#xD;
          -  Stable medication for 3 months prior to the enrollment, and expectedly throughout the&#xD;
             course of study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Scallop allergy&#xD;
&#xD;
          -  Symptomatic obesity, i.e., endocrinal, hypothalamic or drug-induced obesity&#xD;
&#xD;
          -  Hypertension under medication with 4 or more drugs&#xD;
&#xD;
          -  Hepatic disorder with AST ≥ 5 times upper limit of the normal range&#xD;
&#xD;
          -  Mental disorder including schizophrenia and neurosis&#xD;
&#xD;
          -  Alcohol dependence&#xD;
&#xD;
          -  History of malignancy for which treatment completed in the past 5 years&#xD;
&#xD;
          -  Inflammatory disease&#xD;
&#xD;
          -  Use of plasmalogen supplement in the past 3 months&#xD;
&#xD;
          -  Ineligible condition as determined by study physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Takehiko Fujino</last_name>
    <role>Study Chair</role>
    <affiliation>BOOCS Clinic Fukuoka</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BOOCS Clinic Fukuoka</name>
      <address>
        <city>Fukuoka</city>
        <zip>8120025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03295188
org study id: Pls2017-01
nct id: NCT03295188
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects
      of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen
      in obese subjects aged 20-75 years old.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Profile of Mood States 2nd Edition (POMS 2)
time frame: 12 weeks
description: Psychological rating scale to assess transient feelings and mood
measure: Change in body weight
time frame: 12 weeks
measure: Change in waist diameter
time frame: 12 weeks
measure: Change in blood levels of plasmalogen
time frame: 12 weeks
measure: Change in Athens Insomnia Scale (AIS)
time frame: 12 weeks
description: Self-assessment psychometric tool to quantify sleep difficulty
measure: Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein
time frame: 12 weeks
arm group label: Intervention Group
arm group type: Experimental
description: Two 0.5 mg plasmalogen capsules per day
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Two placebo capsules containing no plasmalogen per day
intervention type: Dietary Supplement
intervention name: Plasmalogen
description: Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.
arm group label: Intervention Group
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo Group takes two placebo capsules per day for 12 weeks.
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Takehiko Fujino
role: Study Chair
affiliation: BOOCS Clinic Fukuoka
facility: 
country: Japan
responsible party type: Sponsor