<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/NCT01730898</url>
  </required_header>
  <id_info>
    <org_study_id>BL14</org_study_id>
    <nct_id>NCT01730898</nct_id>
  </id_info>
  <brief_title>Lutein Absorption in Healthy Adults</brief_title>
  <official_title>Lutein Absorption in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Nutrition</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the absorption of lutein when consumed in different oil blends.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma lutein</measure>
    <time_frame>baseline and 336 hours</time_frame>
    <description>adjusted area under the curve at specified postprandial timepoint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma carotenoids</measure>
    <time_frame>2, 4, 6, 8, 12, 24, 48, and 336 hours</time_frame>
    <description>mean concentrations at specified postprandial timepoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma lipid concentrations</measure>
    <time_frame>baseline and 48 hours</time_frame>
    <description>averaged concentrations at specified postprandial timepoints</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Control capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Study product containing lutein</intervention_name>
    <description>delivered in capsule form</description>
    <arm_group_label>Control capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Study product containing lutein</intervention_name>
    <description>delivered in capsule form</description>
    <arm_group_label>Experimental capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects will be eligible for the study if they meet all of the following inclusion&#xD;
        criteria:&#xD;
&#xD;
          -  BMI ≥ 18 and ≤ 25 kg/m2&#xD;
&#xD;
          -  Between 18 and 45 years of age, inclusive&#xD;
&#xD;
          -  Male or a non-pregnant, non-lactating female, nulliparous or at least 6 weeks&#xD;
             postpartum prior to screening visit. A urine pregnancy test is required for all female&#xD;
             subjects unless she is not of childbearing potential. If female is of childbearing&#xD;
             potential, is practicing one of the following methods of birth control (and will&#xD;
             continue through the duration of the study):&#xD;
&#xD;
               -  Condoms, sponge, diaphragm or intrauterine device;&#xD;
&#xD;
               -  Oral or parenteral contraceptives for 3 months prior to screening visit;&#xD;
&#xD;
               -  Vasectomized partner;&#xD;
&#xD;
               -  Total abstinence from sexual intercourse.&#xD;
&#xD;
          -  If on a chronic medication, subject has been on constant dosage for at least two&#xD;
             months prior to screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from the study if they meet any of the following criteria:&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Current chronic disease, including malabsorption or gastrointestinal disorders;&#xD;
             hyperlipidemia; anemia; hemophilia; excessive bleeding; cystic fibrosis; kidney&#xD;
             disease requiring dialysis; diabetes; active malignancy; wasting condition&#xD;
&#xD;
          -  Current chronic contagious, infectious disease, such as active tuberculosis, Hepatitis&#xD;
             B or C,or HIV&#xD;
&#xD;
          -  Vegetarian, or has very selective food habits/dieting&#xD;
&#xD;
          -  Average intake of alcoholic beverages greater than 2 drinks per day&#xD;
&#xD;
          -  Medication or dietary supplement use to lower plasma lipids or affect lipid absorption&#xD;
             or transport, including antibiotics&#xD;
&#xD;
          -  Supplement use that contains carotenoids (multi-vitamin as an example)&#xD;
&#xD;
          -  Known allergy or intolerance to any ingredient found in the study products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Williams</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Biofortis Clinical Research</name>
      <address>
        <city>Addison</city>
        <state>Illinois</state>
        <zip>60101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>July 2, 2013</last_update_submitted>
  <last_update_submitted_qc>July 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 4, 2013</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/NCT01730898
org study id: BL14
nct id: NCT01730898
lead sponsor: 
has dmc: No
This study will evaluate the absorption of lutein when consumed in different oil blends.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Plasma lutein
time frame: baseline and 336 hours
description: adjusted area under the curve at specified postprandial timepoint
measure: Plasma carotenoids
time frame: 2, 4, 6, 8, 12, 24, 48, and 336 hours
description: mean concentrations at specified postprandial timepoints
measure: Plasma lipid concentrations
time frame: baseline and 48 hours
description: averaged concentrations at specified postprandial timepoints
arm group label: Control capsule
arm group type: Active Comparator
description: 2 capsules
arm group label: Experimental capsule
arm group type: Experimental
description: 2 capsules
intervention type: Other
intervention name: Study product containing lutein
description: delivered in capsule form
arm group label: Control capsule
intervention type: Other
intervention name: Study product containing lutein
description: delivered in capsule form
arm group label: Experimental capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Williams
role: Study Chair
affiliation: Abbott Nutrition
facility: 
country: United States
responsible party type: Sponsor