<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/NCT01694680</url>
  </required_header>
  <id_info>
    <org_study_id>NWT-02/Human 4</org_study_id>
    <nct_id>NCT01694680</nct_id>
  </id_info>
  <brief_title>Intervention Trial in Early Age-related Macular Degeneration</brief_title>
  <acronym>I-TEAM</acronym>
  <official_title>Intervention Study to Assess the Effect of Daily Consumption of a Lutein-enriched-egg Beverage on Maintenance of Visual Function in Subjects With Early Signs of Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newtricious R&amp;D BV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sprim Advanced Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Newtricious R&amp;D BV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the I-TEAM project is to assess whether there is a change in visual function&#xD;
      and status of the retina after a year of intervention in subjects with early signs of&#xD;
      Age-related Macular Degeneration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Carotenoid levels</measure>
    <time_frame>12 months</time_frame>
    <description>Levels of lutein and Zeaxanthin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Age-related Macular Degeneration (AMD)</condition>
  <arm_group>
    <arm_group_label>Lutein-enriched-egg beverage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Powder in sachet to prepare beverage</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lutein-enriched-egg beverage (NWT-02)</intervention_name>
    <description>Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage</description>
    <arm_group_label>Lutein-enriched-egg beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>color-, taste- and energy-matched powder without enriched egg-yolk</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Early AMD (AREDS category 2)&#xD;
&#xD;
               -  many small drusen, or&#xD;
&#xD;
               -  a few intermediate-sized (63-124 micrometres in diameter) drusen, or&#xD;
&#xD;
               -  macular pigmentary changes&#xD;
&#xD;
        OR&#xD;
&#xD;
          -  Intermediate AMD (AREDS category 3)&#xD;
&#xD;
               -  extensive intermediate sized (63-124 micrometres in diameter) drusen, or&#xD;
&#xD;
               -  at least one large (&gt;125 micrometers in diameter) drusen or&#xD;
&#xD;
               -  geographic atrophy not involving the foveal centre&#xD;
&#xD;
          -  men and women age ≥50 years&#xD;
&#xD;
          -  BMI 18-35 kg/m2&#xD;
&#xD;
          -  Vision ≥ 20/40 for Snellen visual acuity&#xD;
&#xD;
          -  lutein intake of &lt; 2 mg/day (including supplements)&#xD;
&#xD;
          -  DHA intake of &lt; 150 mg/day (including supplements)&#xD;
&#xD;
          -  must be able to give written informed consent&#xD;
&#xD;
          -  have normal hematologic parameters&#xD;
&#xD;
          -  normal values of plasma albumin&#xD;
&#xD;
          -  normal values for liver and kidney function&#xD;
&#xD;
          -  no use of carotenoid, fish oil, or n3 fatty acid supplements (within 1 month of study&#xD;
             start)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ocular media opacity (severe cataract)&#xD;
&#xD;
          -  history of active small bowel disease or resection&#xD;
&#xD;
          -  atrophic gastritis&#xD;
&#xD;
          -  history of hyperlipidemia or screening values as follows (LDL &gt; 5.33mmol/L or&#xD;
             205mg/dL; triglycerides &gt; 4.52mmol/L or &gt;400 mg/dL)&#xD;
&#xD;
          -  hypertension (&gt;150/90 mm Hg)&#xD;
&#xD;
          -  diabetes mellitus (if also accompanied by signs of diabetic retinopathy)&#xD;
&#xD;
          -  alcohol intake of &gt;2 drinks/day or 14 drinks/week&#xD;
&#xD;
          -  pancreatic disease&#xD;
&#xD;
          -  dementia or Alzheimer's disease&#xD;
&#xD;
          -  anemia, and bleeding disorders&#xD;
&#xD;
          -  known allergy to egg or egg products&#xD;
&#xD;
          -  known allergy to milk or milk products&#xD;
&#xD;
          -  known allergy to cocoa or chocolate products&#xD;
&#xD;
          -  known allergy to fish or fish oils&#xD;
&#xD;
          -  lactose intolerance&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's&#xD;
             disease, cystic fibrosis (as determined by screening interview)&#xD;
&#xD;
          -  medication or supplements that contain a significant level of carotenoids, including&#xD;
             an amount of lutein of more than 0.25 mg per day within 1 month of the study start&#xD;
&#xD;
          -  medications that interfere with fat absorption, e.g. bile sequestrants (as determined&#xD;
             by screening interview)&#xD;
&#xD;
          -  use of antipsychotic, anti manic, or dementia medications&#xD;
&#xD;
          -  smoking or use of nicotine patches or gum (within the past 6 months)&#xD;
&#xD;
          -  subjects having extremely high dietary intakes of carotenoids&#xD;
&#xD;
          -  stroke, head injury with loss of consciousness or seizures&#xD;
&#xD;
          -  for US and UK center: Non English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>E J Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TUFTS University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts Augenklinik - Bonn</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud University Hospital</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525EX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester Royal Eye Hospital - Manchester</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 20, 2016</last_update_submitted>
  <last_update_submitted_qc>September 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AMD</keyword>
  <keyword>Lutein</keyword>
  <keyword>Visual function</keyword>
  <keyword>Early signs of AMD</keyword>
  <keyword>AREDS-category 2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</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/NCT01694680
org study id: NWT-02/Human 4
nct id: NCT01694680
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the I-TEAM project is to assess whether there is a change in visual function
      and status of the retina after a year of intervention in subjects with early signs of
      Age-related Macular Degeneration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual function
time frame: 12 months
measure: Carotenoid levels
time frame: 12 months
description: Levels of lutein and Zeaxanthin
arm group label: Lutein-enriched-egg beverage
arm group type: Active Comparator
description: Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage
arm group label: Placebo
arm group type: Placebo Comparator
description: Powder in sachet to prepare beverage
intervention type: Dietary Supplement
intervention name: Lutein-enriched-egg beverage (NWT-02)
description: Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage
arm group label: Lutein-enriched-egg beverage
intervention type: Dietary Supplement
intervention name: Placebo
description: color-, taste- and energy-matched powder without enriched egg-yolk
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: E J Johnson, PhD
role: Principal Investigator
affiliation: Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Netherlands
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration