<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/NCT03822169</url>
  </required_header>
  <id_info>
    <org_study_id>NL67054.081.18</org_study_id>
    <nct_id>NCT03822169</nct_id>
  </id_info>
  <brief_title>Choline Uptake Study</brief_title>
  <acronym>CUP</acronym>
  <official_title>Choline Uptake Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AAK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University and Research</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>
      The study is a randomised, cross-over, double blind, controlled trial in which study&#xD;
      participants will visit the research facility on two occasions under fasting conditions with&#xD;
      a washout period of one week. During each visit, study subjects will receive a test shake&#xD;
      with phospholipid-bound choline or a control shake with choline added as a salt and DHA added&#xD;
      separately. The two shakes will be given in randomised order and blood will be collected via&#xD;
      a catheter before and up-to 6 hours after choline consumption. All study participants will&#xD;
      receive a standardised evening meal prior to each study day and asked not to drink alcohol or&#xD;
      perform heavy exercise the day before each study day. Study subjects are also asked to avoid&#xD;
      choline rich products the day before each test day. Study participants are offered a meal&#xD;
      after the test day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Choline is water-soluble vitamin-like essential nutrient. It is made in small amounts by the&#xD;
      liver, but humans need to receive choline through the diet or by supplementation for proper&#xD;
      health. Pregnancy and lactation are times when demand for choline is especially high. Infant&#xD;
      formula not made from cow's milk is therefore supplemented with choline. Choline is therefore&#xD;
      widely used. It is normally added to food products as a salt. However, if choline is present&#xD;
      in a natural form, bound to phospholipids, it may be more efficiently absorbed.&#xD;
      Docosahexaenoic acids (DHA) are also bound to these phospholipids.&#xD;
&#xD;
      The primary objective is determine choline uptake and bioavailability after consumption of a&#xD;
      test shake with phospholipid-bound choline (and DHA), and to compare this to a control shake&#xD;
      with choline added as a salt (and DHA added as an oil). Secondary objective is to compare the&#xD;
      uptake and bioavailability of DHA after the two shakes.&#xD;
&#xD;
      The study is a cross-over, double blind, controlled trial in which study participants will&#xD;
      visit the research facility on two occasions under fasting conditions. Subjects will receive&#xD;
      two different choline products in randomized order with a washout period of one week. Blood&#xD;
      will be collected via a catheter before and up-to 6 hours after choline consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">February 19, 2019</completion_date>
  <primary_completion_date type="Actual">February 19, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in plasma choline concentration</measure>
    <time_frame>blood samples will be taken before and up to 6 hours after shake consumption</time_frame>
    <description>postprandial test, determine choline in blood samples collected before and after a shake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in plasma betaine concentration</measure>
    <time_frame>blood samples will be taken before and up to 6 hours after shake consumption</time_frame>
    <description>postprandial test, determine betaine in blood samples collected before and after a shake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in plasma dimethylglycine concentration</measure>
    <time_frame>blood samples will be taken before and up to 6 hours after shake consumption</time_frame>
    <description>postprandial test, determine dimethylglycine in blood samples collected before and after a shake</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plasma DHA concentration</measure>
    <time_frame>blood samples will be taken before and up to 6 hours after shake consumption</time_frame>
    <description>postprandial test, determine DHA in blood samples collected before and after a shake</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Choline Uptake</condition>
  <condition>Kinetics</condition>
  <arm_group>
    <arm_group_label>Choline added as a phospholipid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A shake with phospholipid-bound choline (and bound DHA),</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Choline added as a salt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control shake with choline added as a salt and added DHA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Choline added as a phospholipid</intervention_name>
    <description>A shake with 3000 mg choline added as a phospholipid</description>
    <arm_group_label>Choline added as a phospholipid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Choline added as a salt</intervention_name>
    <description>A shake with 3000 mg choline added as a salt</description>
    <arm_group_label>Choline added as a salt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy men and women&#xD;
&#xD;
          -  Age between 30 and 70 years&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5 and 24.9 kg/m2&#xD;
&#xD;
          -  Having veins suitable for blood sampling via a catheter (judged by study nurse/&#xD;
             medical doctor)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes,&#xD;
             anaemia, hepatitis, cardiovascular disease)&#xD;
&#xD;
          -  History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints&#xD;
&#xD;
          -  History of liver dysfunction (cirrhosis, hepatitis) or liver surgery&#xD;
&#xD;
          -  Kidney dysfunction (self-reported)&#xD;
&#xD;
          -  Use of medication that may influence the study results,&#xD;
&#xD;
          -  such as laxatives, stomach protectors and drugs that can affect intestinal motility.&#xD;
&#xD;
          -  Use of choline or fish oil supplements&#xD;
&#xD;
          -  Reported slimming, medically prescribed or vegan diet&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Alcohol intake ≥4 glasses of alcoholic beverages per day&#xD;
&#xD;
          -  Pregnant, lactating or wishing to become pregnant in the period of the study&#xD;
             (self-reported)&#xD;
&#xD;
          -  Abuse of illicit drugs&#xD;
&#xD;
          -  Food allergies for products that we use in the study&#xD;
&#xD;
          -  Participation in another clinical trial at the same time&#xD;
&#xD;
          -  Being an employee of the department Consumer Science &amp; Health group of Wageningen Food&#xD;
             &amp; Biobased Research and/or Human Nutrition and Health&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diederik Esser, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University and Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stichting Wageningen Research</name>
      <address>
        <city>Wageningen</city>
        <state>Gelderland</state>
        <zip>6708 WG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>April 11, 2019</last_update_submitted>
  <last_update_submitted_qc>April 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wageningen University and Research</investigator_affiliation>
    <investigator_full_name>Diederik Esser</investigator_full_name>
    <investigator_title>project leader clinical trials</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choline</mesh_term>
  </intervention_browse>
  <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/NCT03822169
org study id: NL67054.081.18
nct id: NCT03822169
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a randomised, cross-over, double blind, controlled trial in which study
      participants will visit the research facility on two occasions under fasting conditions with
      a washout period of one week. During each visit, study subjects will receive a test shake
      with phospholipid-bound choline or a control shake with choline added as a salt and DHA added
      separately. The two shakes will be given in randomised order and blood will be collected via
      a catheter before and up-to 6 hours after choline consumption. All study participants will
      receive a standardised evening meal prior to each study day and asked not to drink alcohol or
      perform heavy exercise the day before each study day. Study subjects are also asked to avoid
      choline rich products the day before each test day. Study participants are offered a meal
      after the test day.
Choline is water-soluble vitamin-like essential nutrient. It is made in small amounts by the
      liver, but humans need to receive choline through the diet or by supplementation for proper
      health. Pregnancy and lactation are times when demand for choline is especially high. Infant
      formula not made from cow's milk is therefore supplemented with choline. Choline is therefore
      widely used. It is normally added to food products as a salt. However, if choline is present
      in a natural form, bound to phospholipids, it may be more efficiently absorbed.
      Docosahexaenoic acids (DHA) are also bound to these phospholipids.

      The primary objective is determine choline uptake and bioavailability after consumption of a
      test shake with phospholipid-bound choline (and DHA), and to compare this to a control shake
      with choline added as a salt (and DHA added as an oil). Secondary objective is to compare the
      uptake and bioavailability of DHA after the two shakes.

      The study is a cross-over, double blind, controlled trial in which study participants will
      visit the research facility on two occasions under fasting conditions. Subjects will receive
      two different choline products in randomized order with a washout period of one week. Blood
      will be collected via a catheter before and up-to 6 hours after choline consumption.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: change in plasma choline concentration
time frame: blood samples will be taken before and up to 6 hours after shake consumption
description: postprandial test, determine choline in blood samples collected before and after a shake
measure: change in plasma betaine concentration
time frame: blood samples will be taken before and up to 6 hours after shake consumption
description: postprandial test, determine betaine in blood samples collected before and after a shake
measure: change in plasma dimethylglycine concentration
time frame: blood samples will be taken before and up to 6 hours after shake consumption
description: postprandial test, determine dimethylglycine in blood samples collected before and after a shake
measure: Change in plasma DHA concentration
time frame: blood samples will be taken before and up to 6 hours after shake consumption
description: postprandial test, determine DHA in blood samples collected before and after a shake
arm group label: Choline added as a phospholipid
arm group type: Experimental
description: A shake with phospholipid-bound choline (and bound DHA),
arm group label: Choline added as a salt
arm group type: Active Comparator
description: control shake with choline added as a salt and added DHA.
intervention type: Dietary Supplement
intervention name: Choline added as a phospholipid
description: A shake with 3000 mg choline added as a phospholipid
arm group label: Choline added as a phospholipid
intervention type: Dietary Supplement
intervention name: Choline added as a salt
description: A shake with 3000 mg choline added as a salt
arm group label: Choline added as a salt
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Diederik Esser, PhD
role: Principal Investigator
affiliation: Wageningen University and Research
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Wageningen University and Research
investigator full name: Diederik Esser
investigator title: project leader clinical trials
mesh term: Choline
sharing ipd: No