<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/NCT01672359</url>
  </required_header>
  <id_info>
    <org_study_id>20090985</org_study_id>
    <nct_id>NCT01672359</nct_id>
  </id_info>
  <brief_title>Evaluating Whole Foods Supplementation on Cognition</brief_title>
  <official_title>The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Standard Process Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC&#xD;
      Synergy® and Catalyn® on cognitive and immune function markers and quality of life among&#xD;
      healthy older adults with no history of significant cognitive deficits&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive Measures</measure>
    <time_frame>6 months</time_frame>
    <description>The measures included the MMSE, the Stroop Color and Word Test (SCWT), the Trail Making Test Parts A and B (TMT-A, TMT-B), the Controlled Oral Word Association test (COWA), the Digit Symbol subtest of the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), and the Hopkins Verbal Learning Test-Revised (HVLT-R)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measures</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of Well-Being Scale (QWBS) Medical Outcomes Study Short Form 36 (SF 36) Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune Function Markers</measure>
    <time_frame>6 months</time_frame>
    <description>interleukin [IL]-2, IL-4, IL-6, IL-8, IL-10, IL-1α, IL-1β, interferon [IFN]-γ, tumor necrosis factor [TNF]-α, monocyte chemotactic protein [MCP]-1, vascular endothelial growth factor [VEGF], and epidermal growth factor [EGF]</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Sub-optimal Cognitive Function</condition>
  <condition>Sub-optimal Immune Function</condition>
  <arm_group>
    <arm_group_label>Ginkgo Synergy® and Choline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ginkgo Synergy® (120 mg/day Ginkgo biloba leaf with 80 mg/day Ginkgo biloba whole extract combined with 40 mg/day Grape Seed extract) and Choline (700 mg choline/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OPC Synergy® and Catalyn</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OPC Synergy® (100 mg/day of Grape Seed extract with 50 mg/day Green Tea extract (60% catechins)) and Catalyn® (1,248 IU/day of Vitamin D, 4,800 IU/day of Vitamin A, combined with vitamin C, thiamine, riboflavin, and vitamin B6)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>cellulose pills to simulate actual products</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ginkgo Synergy® and Choline</intervention_name>
    <description>3 tablets 2 times per day with breakfast and dinner over 6 months</description>
    <arm_group_label>Ginkgo Synergy® and Choline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>OPC Synergy® and Catalyn</intervention_name>
    <description>3 tablets 2 times per day with breakfast and dinner over 6 months</description>
    <arm_group_label>OPC Synergy® and Catalyn</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 years of age and older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Not living in a skilled or intermediate care level nursing facility&#xD;
&#xD;
          -  No use of dietary supplements for cognitive functioning two weeks before enrolling in&#xD;
             the study and during the length of the trial&#xD;
&#xD;
          -  A Mini-Mental State Exam (MMSE) score ≥ 23&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A cognitive deficit greater than that indicated according to the MMSE score&#xD;
&#xD;
          -  A clinical diagnosis of AD and/or related disorders&#xD;
&#xD;
          -  A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder,&#xD;
             major depression with psychotic features, delirium, and alcohol or substance&#xD;
             abuse/dependence&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Aphasia or sensory, motor, and/or visual disturbances that would have interfered with&#xD;
             psychometric tests&#xD;
&#xD;
          -  Gastrointestinal disorders causing impaired absorption of the study supplements&#xD;
&#xD;
          -  Insulin-dependent diabetes&#xD;
&#xD;
          -  Major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic,&#xD;
             gastrointestinal, or seizure&#xD;
&#xD;
          -  Hematologic or oncologic disorders treated with chemotherapy in the previous two years&#xD;
&#xD;
          -  Active chemotherapy or radiation treatment for cancer&#xD;
&#xD;
          -  Current cigarette smoking&#xD;
&#xD;
          -  More than three major medical or psychiatric hospitalizations in the past year&#xD;
&#xD;
          -  Diagnosis of a terminal illness&#xD;
&#xD;
          -  A T score &gt; 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)&#xD;
&#xD;
          -  A score ≥ 29 on the Beck Depression Inventory-II (BDI) (15)&#xD;
&#xD;
          -  Prescription and OTC sympathomimetic amines and antihistamines within 2 days of an&#xD;
             assessment visit&#xD;
&#xD;
          -  Cognition enhancing drugs consumption such as Donepezil, Rivastigmine, Galantamine,&#xD;
             and Tacrine&#xD;
&#xD;
          -  Coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants&#xD;
&#xD;
          -  Cognition-enhancing supplements, herbs, or antioxidants that could not be stopped&#xD;
             during the trial&#xD;
&#xD;
          -  Participating in a concurrent trial for drugs, supplements, or treatment that affects&#xD;
             behavior or cognitive function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Lewis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Building</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>John E. Lewis</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>cognitive functioning</keyword>
  <keyword>immune function</keyword>
  <keyword>cytokines</keyword>
  <keyword>growth factors</keyword>
  <keyword>quality of life</keyword>
  <keyword>dietary supplementation</keyword>
  <keyword>Ginkgo biloba</keyword>
  <keyword>Improvement of cognitive function</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choline</mesh_term>
  </intervention_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/NCT01672359
org study id: 20090985
nct id: NCT01672359
lead sponsor: 
collaborator: 
has dmc: No
A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC
      Synergy® and Catalyn® on cognitive and immune function markers and quality of life among
      healthy older adults with no history of significant cognitive deficits
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cognitive Measures
time frame: 6 months
description: The measures included the MMSE, the Stroop Color and Word Test (SCWT), the Trail Making Test Parts A and B (TMT-A, TMT-B), the Controlled Oral Word Association test (COWA), the Digit Symbol subtest of the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), and the Hopkins Verbal Learning Test-Revised (HVLT-R)
measure: Quality of Life Measures
time frame: 6 months
description: Quality of Well-Being Scale (QWBS) Medical Outcomes Study Short Form 36 (SF 36) Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI)
measure: Immune Function Markers
time frame: 6 months
description: interleukin [IL]-2, IL-4, IL-6, IL-8, IL-10, IL-1α, IL-1β, interferon [IFN]-γ, tumor necrosis factor [TNF]-α, monocyte chemotactic protein [MCP]-1, vascular endothelial growth factor [VEGF], and epidermal growth factor [EGF]
arm group label: Ginkgo Synergy® and Choline
arm group type: Experimental
description: Ginkgo Synergy® (120 mg/day Ginkgo biloba leaf with 80 mg/day Ginkgo biloba whole extract combined with 40 mg/day Grape Seed extract) and Choline (700 mg choline/day)
arm group label: OPC Synergy® and Catalyn
arm group type: Experimental
description: OPC Synergy® (100 mg/day of Grape Seed extract with 50 mg/day Green Tea extract (60% catechins)) and Catalyn® (1,248 IU/day of Vitamin D, 4,800 IU/day of Vitamin A, combined with vitamin C, thiamine, riboflavin, and vitamin B6)
arm group label: Placebo
arm group type: Placebo Comparator
description: cellulose pills to simulate actual products
intervention type: Dietary Supplement
intervention name: Ginkgo Synergy® and Choline
description: 3 tablets 2 times per day with breakfast and dinner over 6 months
arm group label: Ginkgo Synergy® and Choline
intervention type: Dietary Supplement
intervention name: OPC Synergy® and Catalyn
description: 3 tablets 2 times per day with breakfast and dinner over 6 months
arm group label: OPC Synergy® and Catalyn
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John Lewis, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: John E. Lewis
investigator title: Associate Professor
mesh term: Choline