<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/NCT03039023</url>
  </required_header>
  <id_info>
    <org_study_id>16-1048</org_study_id>
    <nct_id>NCT03039023</nct_id>
  </id_info>
  <brief_title>Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans</brief_title>
  <acronym>EGGS</acronym>
  <official_title>Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans (EGGS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are interested in learning more about choline, a nutrient required by the&#xD;
      body. The body does make some choline, but it does not make enough to support health and the&#xD;
      rest must be acquired through diet. Eggs, and especially egg yolks, are a major dietary&#xD;
      source of choline. Choline can also be given as a dietary supplement. Ingestion of choline&#xD;
      supplements has been linked to an increased concentration of a compound called TMAO&#xD;
      (trimethylamine N-oxide). Elevated TMAO levels have been linked to higher heart disease risk.&#xD;
      With this study, the investigators hope to learn whether there is a difference in the way&#xD;
      your body responds to the ingestion of a choline supplement versus the choline found within&#xD;
      eggs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The principal goal for the study is to examine whether there is a difference between the&#xD;
      ingestion of choline through supplements versus choline found within eggs on plasma TMAO&#xD;
      levels. The investigators have previously shown that dietary intake of trimethylamines,&#xD;
      including the choline group of phosphatidylcholine (PC), is mechanistically linked to&#xD;
      cardiovascular disease risk and that the metabolism of these trimethylamine nutrients in&#xD;
      humans is modulated by the intestinal microbes (gut microbes). Additionally, extensive animal&#xD;
      studies link an essential role of gut microbiota to the metabolism of choline and the&#xD;
      production of metabolites that promote / accelerate atherosclerotic processes. The&#xD;
      investigators have also recently shown a 10-fold increase in plasma TMAO levels following&#xD;
      supplementation with choline bitartrate supplements. However, another pilot study by a&#xD;
      collaborator (unpublished) did not show the same increase in plasma TMAO levels following the&#xD;
      ingestion of whole eggs, a major dietary source of choline. Therefore, with this study the&#xD;
      investigators wish to examine the differences, if any, between the ingestion of an equivalent&#xD;
      mass of total choline in the free form (as bitartrate salt) as a supplement vs. within whole&#xD;
      eggs.&#xD;
&#xD;
      Eggs, and specifically the egg yolk, contain a large amount of total choline. However, egg&#xD;
      white contains potential anti-microbial peptides that could influence gut microbial&#xD;
      composition and function, and therefore impact conversion of choline into TMA and TMAO&#xD;
      observed in subjects. Therefore, the investigators hypothesize that the consumption of whole&#xD;
      eggs (hardboiled) will not elevate plasma TMAO levels to the same extent as a comparable&#xD;
      amount of total choline ingested in capsule form as the choline bitartrate salt. The&#xD;
      investigators further hypothesize that the consumption of egg white with choline bitartrate&#xD;
      tablets may result in less of a rise in TMAO levels than ingestion of the choline bitartrate&#xD;
      supplement alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2016</start_date>
  <completion_date type="Actual">September 3, 2020</completion_date>
  <primary_completion_date type="Actual">April 10, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite</measure>
    <time_frame>Baseline, 28 days</time_frame>
    <description>Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Platelet Function With Increased Choline Intake</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Plasma Levels of Fasting Choline</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Plasma Levels of Fasting Carnitine.</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Plasma Levels of Fasting Betaine.</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Lipid Profile, Total Cholesterol</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Changes in total cholesterol levels between baseline and Day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Lipid Profile, HDL</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Changes in measured HDL levels between baseline and Day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Lipid Profile, LDL</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Changes in measured LDL levels between baseline and Day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Lipid Profile, Triglycerides</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Changes in measured triglyceride levels between baseline and Day 28</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Whole Hardboiled Eggs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Choline Bitartrate Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hardboiled Eggs + Choline Bitartrate Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Egg Whites + Choline Bitartrate Tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phosphatidylcholine Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Choline Bitartrate</intervention_name>
    <description>500mg choline bitartrate tablets</description>
    <arm_group_label>Choline Bitartrate Tablets</arm_group_label>
    <arm_group_label>Egg Whites + Choline Bitartrate Tablets</arm_group_label>
    <arm_group_label>Hardboiled Eggs + Choline Bitartrate Tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-cooked, pre-peeled whole hardboiled eggs</intervention_name>
    <description>Obtained from a commercial source.</description>
    <arm_group_label>Hardboiled Eggs + Choline Bitartrate Tablets</arm_group_label>
    <arm_group_label>Whole Hardboiled Eggs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Egg whites from pre-cooked, pre-peeled hardboiled eggs</intervention_name>
    <description>Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
    <arm_group_label>Egg Whites + Choline Bitartrate Tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Phosphatidylcholine capsules</intervention_name>
    <description>420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
    <arm_group_label>Phosphatidylcholine Capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women age 18 years or above.&#xD;
&#xD;
          -  Willing to remain on aspirin or stay off aspirin or aspirin products for 1 week prior&#xD;
             to starting the study and throughout the study period.&#xD;
&#xD;
          -  Able to provide informed consent and comply with study protocol.&#xD;
&#xD;
          -  Able to be off all other supplements during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant chronic illness.&#xD;
&#xD;
          -  Active infection or received antibiotics within 1 month of study enrollment.&#xD;
&#xD;
          -  Use of over-the-counter probiotic within the past month&#xD;
&#xD;
          -  Chronic gastrointestinal disorders, such as ulcerative colitis or Crohn's disease.&#xD;
&#xD;
          -  Allergy to eggs or lactose.&#xD;
&#xD;
          -  Having undergone bariatric procedures or surgeries such as gastric banding or bypass.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Any condition that, in the judgment of the Investigator, would place a patient at&#xD;
             undue risk by being enrolled in the trial or cause inability to comply with the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>W. H. Wilson Tang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://data.nal.usda.gov/system/files/Choln02.pdf</url>
    <description>Patterson K, Bhagwat S, Williams J, Howe J, and Holden J. USDA Database for the Choline Content of Common Foods, Release Two. January 2008.</description>
  </link>
  <reference>
    <citation>Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.</citation>
    <PMID>21475195</PMID>
  </reference>
  <reference>
    <citation>Rebouche CJ, Chenard CA. Metabolic fate of dietary carnitine in human adults: identification and quantification of urinary and fecal metabolites. J Nutr. 1991 Apr;121(4):539-46. doi: 10.1093/jn/121.4.539.</citation>
    <PMID>2007906</PMID>
  </reference>
  <reference>
    <citation>Bidulescu A, Chambless LE, Siega-Riz AM, Zeisel SH, Heiss G. Repeatability and measurement error in the assessment of choline and betaine dietary intake: the Atherosclerosis Risk in Communities (ARIC) study. Nutr J. 2009 Feb 20;8:14. doi: 10.1186/1475-2891-8-14.</citation>
    <PMID>19232103</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>April 21, 2021</results_first_submitted>
  <results_first_submitted_qc>April 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 14, 2021</results_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Wilson Tang</investigator_full_name>
    <investigator_title>Staff, Cardiovascular Medicine, The Cleveland Clinic; Staff, Cellular and Molecular Medicine, The Cleveland Clinic Lerner Research Institute</investigator_title>
  </responsible_party>
  <keyword>TMAO</keyword>
  <keyword>choline</keyword>
  <keyword>eggs</keyword>
  <keyword>gastrointestinal microbiome</keyword>
  <keyword>healthy volunteers</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03039023/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Whole Hardboiled Eggs</title>
          <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
        </group>
        <group group_id="P2">
          <title>Choline Bitartrate Tablets</title>
          <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
        </group>
        <group group_id="P3">
          <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
          <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
        </group>
        <group group_id="P4">
          <title>Egg Whites + Choline Bitartrate Tablets</title>
          <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
        </group>
        <group group_id="P5">
          <title>Phosphatidylcholine Capsules</title>
          <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Whole Hardboiled Eggs</title>
          <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
        </group>
        <group group_id="B2">
          <title>Choline Bitartrate Tablets</title>
          <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
        </group>
        <group group_id="B3">
          <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
          <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
        </group>
        <group group_id="B4">
          <title>Egg Whites + Choline Bitartrate Tablets</title>
          <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
        </group>
        <group group_id="B5">
          <title>Phosphatidylcholine Capsules</title>
          <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="18"/>
            <count group_id="B5" value="10"/>
            <count group_id="B6" value="82"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.5" lower_limit="23.3" upper_limit="28.8"/>
                    <measurement group_id="B2" value="27.0" lower_limit="23.0" upper_limit="37.0"/>
                    <measurement group_id="B3" value="37.0" lower_limit="24.0" upper_limit="50.3"/>
                    <measurement group_id="B4" value="30.0" lower_limit="25.0" upper_limit="35.8"/>
                    <measurement group_id="B5" value="31.5" lower_limit="25.8" upper_limit="47.3"/>
                    <measurement group_id="B6" value="28.0" lower_limit="24.0" upper_limit="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>TMAO at Baseline</title>
          <units>uM</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.0" lower_limit="1.4" upper_limit="3.5"/>
                    <measurement group_id="B2" value="1.9" lower_limit="1.4" upper_limit="3.4"/>
                    <measurement group_id="B3" value="2.3" lower_limit="1.5" upper_limit="2.8"/>
                    <measurement group_id="B4" value="2.6" lower_limit="1.8" upper_limit="5.3"/>
                    <measurement group_id="B5" value="2.8" lower_limit="2.0" upper_limit="5.1"/>
                    <measurement group_id="B6" value="2.3" lower_limit="1.5" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite</title>
        <description>Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry.</description>
        <time_frame>Baseline, 28 days</time_frame>
        <population>All participants with TMAO measured at baseline and Day 28.</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite</title>
          <description>Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry.</description>
          <population>All participants with TMAO measured at baseline and Day 28.</population>
          <units>uM</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.4" upper_limit="3.5"/>
                    <measurement group_id="O2" value="1.9" lower_limit="1.4" upper_limit="3.4"/>
                    <measurement group_id="O3" value="2.3" lower_limit="1.5" upper_limit="2.8"/>
                    <measurement group_id="O4" value="2.6" lower_limit="1.8" upper_limit="5.3"/>
                    <measurement group_id="O5" value="2.8" lower_limit="2.0" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.9" upper_limit="3.7"/>
                    <measurement group_id="O2" value="11.1" lower_limit="7.1" upper_limit="25.4"/>
                    <measurement group_id="O3" value="12.3" lower_limit="5.1" upper_limit="26.5"/>
                    <measurement group_id="O4" value="28.1" lower_limit="9.2" upper_limit="44.1"/>
                    <measurement group_id="O5" value="3.4" lower_limit="2.6" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.20</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.27</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Platelet Function With Increased Choline Intake</title>
        <description>The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Platelet Function With Increased Choline Intake</title>
          <description>The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.</description>
          <units>aggregation percentage</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="1.4" upper_limit="5.3"/>
                    <measurement group_id="O2" value="2.6" lower_limit="1.2" upper_limit="7.2"/>
                    <measurement group_id="O3" value="2.3" lower_limit="1.6" upper_limit="3.0"/>
                    <measurement group_id="O4" value="3.0" lower_limit="2.3" upper_limit="5.0"/>
                    <measurement group_id="O5" value="2.8" lower_limit="2.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.5" upper_limit="7.7"/>
                    <measurement group_id="O2" value="12.8" lower_limit="7.6" upper_limit="27.2"/>
                    <measurement group_id="O3" value="12.3" lower_limit="6.1" upper_limit="25.7"/>
                    <measurement group_id="O4" value="29.4" lower_limit="17.9" upper_limit="43.3"/>
                    <measurement group_id="O5" value="3.4" lower_limit="2.6" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.10</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.0002</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.01</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.006</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.79</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections</title>
        <description>Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections</title>
          <description>Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.</description>
          <units>mg in 24 hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" lower_limit="13.0" upper_limit="44.3"/>
                    <measurement group_id="O2" value="26.2" lower_limit="15.6" upper_limit="40.3"/>
                    <measurement group_id="O3" value="27.5" lower_limit="9.1" upper_limit="36.2"/>
                    <measurement group_id="O4" value="29.3" lower_limit="18.4" upper_limit="45.9"/>
                    <measurement group_id="O5" value="15.8" lower_limit="12.9" upper_limit="35.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" lower_limit="23.1" upper_limit="36.7"/>
                    <measurement group_id="O2" value="139.0" lower_limit="90.1" upper_limit="308.9"/>
                    <measurement group_id="O3" value="221.8" lower_limit="166.3" upper_limit="294.3"/>
                    <measurement group_id="O4" value="186.9" lower_limit="91.2" upper_limit="232.4"/>
                    <measurement group_id="O5" value="33.1" lower_limit="19.9" upper_limit="64.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.28</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.11</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Plasma Levels of Fasting Choline</title>
        <description>Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Plasma Levels of Fasting Choline</title>
          <description>Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.</description>
          <units>uM</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="6.6" upper_limit="10.2"/>
                    <measurement group_id="O2" value="7.5" lower_limit="6.5" upper_limit="9.3"/>
                    <measurement group_id="O3" value="8.5" lower_limit="7.6" upper_limit="11.2"/>
                    <measurement group_id="O4" value="9.5" lower_limit="7.6" upper_limit="11.6"/>
                    <measurement group_id="O5" value="7.6" lower_limit="6.7" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" lower_limit="8.9" upper_limit="12.4"/>
                    <measurement group_id="O2" value="12.9" lower_limit="10.8" upper_limit="16.0"/>
                    <measurement group_id="O3" value="14.0" lower_limit="11.7" upper_limit="15.7"/>
                    <measurement group_id="O4" value="12.8" lower_limit="10.2" upper_limit="14.1"/>
                    <measurement group_id="O5" value="10.6" lower_limit="9.2" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.005</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.009</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.04</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Plasma Levels of Fasting Carnitine.</title>
        <description>Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Plasma Levels of Fasting Carnitine.</title>
          <description>Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.</description>
          <units>uM</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" lower_limit="16.3" upper_limit="22.8"/>
                    <measurement group_id="O2" value="21.2" lower_limit="16.6" upper_limit="25.1"/>
                    <measurement group_id="O3" value="21.5" lower_limit="16.8" upper_limit="24.8"/>
                    <measurement group_id="O4" value="21.1" lower_limit="16.5" upper_limit="26.6"/>
                    <measurement group_id="O5" value="23.4" lower_limit="17.8" upper_limit="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="13.4" upper_limit="27.9"/>
                    <measurement group_id="O2" value="18.7" lower_limit="15.5" upper_limit="21.0"/>
                    <measurement group_id="O3" value="15.6" lower_limit="10.9" upper_limit="19.4"/>
                    <measurement group_id="O4" value="18.9" lower_limit="15.2" upper_limit="23.2"/>
                    <measurement group_id="O5" value="20.8" lower_limit="19.1" upper_limit="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.93</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.01</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.003</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.04</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.99</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Plasma Levels of Fasting Betaine.</title>
        <description>Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Plasma Levels of Fasting Betaine.</title>
          <description>Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.</description>
          <units>uM</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1" lower_limit="23.6" upper_limit="48.3"/>
                    <measurement group_id="O2" value="38.2" lower_limit="28.7" upper_limit="48.7"/>
                    <measurement group_id="O3" value="30.7" lower_limit="18.4" upper_limit="35.7"/>
                    <measurement group_id="O4" value="38.7" lower_limit="23.3" upper_limit="47.7"/>
                    <measurement group_id="O5" value="33.6" lower_limit="23.3" upper_limit="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.7" lower_limit="29.4" upper_limit="55.5"/>
                    <measurement group_id="O2" value="69.0" lower_limit="54.4" upper_limit="82.2"/>
                    <measurement group_id="O3" value="46.9" lower_limit="33.9" upper_limit="67.5"/>
                    <measurement group_id="O4" value="59.8" lower_limit="41.6" upper_limit="65.6"/>
                    <measurement group_id="O5" value="46.3" lower_limit="28.3" upper_limit="64.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.02</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.001</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>For equivalence testing, the difference was assumed to be 0.</non_inferiority_desc>
            <p_value>0.02</p_value>
            <p_value_desc>A p-value &lt;0.05 was considered significant.</p_value_desc>
            <method>Wilcoxon Signed Rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Lipid Profile, Total Cholesterol</title>
        <description>Changes in total cholesterol levels between baseline and Day 28</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Lipid Profile, Total Cholesterol</title>
          <description>Changes in total cholesterol levels between baseline and Day 28</description>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156" lower_limit="145" upper_limit="175"/>
                    <measurement group_id="O2" value="180" lower_limit="147" upper_limit="201"/>
                    <measurement group_id="O3" value="187" lower_limit="172" upper_limit="204"/>
                    <measurement group_id="O4" value="186" lower_limit="150" upper_limit="189"/>
                    <measurement group_id="O5" value="175" lower_limit="159" upper_limit="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158" lower_limit="136" upper_limit="180"/>
                    <measurement group_id="O2" value="172" lower_limit="157" upper_limit="191"/>
                    <measurement group_id="O3" value="198" lower_limit="168" upper_limit="221"/>
                    <measurement group_id="O4" value="178" lower_limit="157" upper_limit="193"/>
                    <measurement group_id="O5" value="172" lower_limit="151" upper_limit="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Lipid Profile, HDL</title>
        <description>Changes in measured HDL levels between baseline and Day 28</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Lipid Profile, HDL</title>
          <description>Changes in measured HDL levels between baseline and Day 28</description>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" lower_limit="44" upper_limit="66"/>
                    <measurement group_id="O2" value="49" lower_limit="40" upper_limit="60"/>
                    <measurement group_id="O3" value="57" lower_limit="50" upper_limit="65"/>
                    <measurement group_id="O4" value="48" lower_limit="39" upper_limit="63"/>
                    <measurement group_id="O5" value="61" lower_limit="49" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" lower_limit="44" upper_limit="65"/>
                    <measurement group_id="O2" value="51" lower_limit="44" upper_limit="60"/>
                    <measurement group_id="O3" value="56" lower_limit="49" upper_limit="74"/>
                    <measurement group_id="O4" value="50" lower_limit="41" upper_limit="57"/>
                    <measurement group_id="O5" value="62" lower_limit="42" upper_limit="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Lipid Profile, LDL</title>
        <description>Changes in measured LDL levels between baseline and Day 28</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Lipid Profile, LDL</title>
          <description>Changes in measured LDL levels between baseline and Day 28</description>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" lower_limit="72" upper_limit="102"/>
                    <measurement group_id="O2" value="90" lower_limit="80" upper_limit="124"/>
                    <measurement group_id="O3" value="108" lower_limit="98" upper_limit="120"/>
                    <measurement group_id="O4" value="104" lower_limit="86" upper_limit="124"/>
                    <measurement group_id="O5" value="107" lower_limit="90" upper_limit="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="71" upper_limit="110"/>
                    <measurement group_id="O2" value="94" lower_limit="82" upper_limit="119"/>
                    <measurement group_id="O3" value="118" lower_limit="87" upper_limit="132"/>
                    <measurement group_id="O4" value="101" lower_limit="87" upper_limit="121"/>
                    <measurement group_id="O5" value="106" lower_limit="79" upper_limit="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Lipid Profile, Triglycerides</title>
        <description>Changes in measured triglyceride levels between baseline and Day 28</description>
        <time_frame>Baseline, Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Hardboiled Eggs</title>
            <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O2">
            <title>Choline Bitartrate Tablets</title>
            <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
          </group>
          <group group_id="O3">
            <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
          </group>
          <group group_id="O4">
            <title>Egg Whites + Choline Bitartrate Tablets</title>
            <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
          </group>
          <group group_id="O5">
            <title>Phosphatidylcholine Capsules</title>
            <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Lipid Profile, Triglycerides</title>
          <description>Changes in measured triglyceride levels between baseline and Day 28</description>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="70" upper_limit="112"/>
                    <measurement group_id="O2" value="106" lower_limit="74" upper_limit="134"/>
                    <measurement group_id="O3" value="103" lower_limit="89" upper_limit="125"/>
                    <measurement group_id="O4" value="122" lower_limit="52" upper_limit="156"/>
                    <measurement group_id="O5" value="74" lower_limit="67" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="57" upper_limit="116"/>
                    <measurement group_id="O2" value="96" lower_limit="82" upper_limit="141"/>
                    <measurement group_id="O3" value="97" lower_limit="80" upper_limit="111"/>
                    <measurement group_id="O4" value="109" lower_limit="69" upper_limit="170"/>
                    <measurement group_id="O5" value="84" lower_limit="67" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected during study participation, up to 30 days from enrollment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Whole Hardboiled Eggs</title>
          <description>Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
        </group>
        <group group_id="E2">
          <title>Choline Bitartrate Tablets</title>
          <description>Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets</description>
        </group>
        <group group_id="E3">
          <title>Hardboiled Eggs + Choline Bitartrate Tablets</title>
          <description>Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.</description>
        </group>
        <group group_id="E4">
          <title>Egg Whites + Choline Bitartrate Tablets</title>
          <description>Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.&#xD;
Choline Bitartrate: 500mg choline bitartrate tablets&#xD;
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.</description>
        </group>
        <group group_id="E5">
          <title>Phosphatidylcholine Capsules</title>
          <description>Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.&#xD;
420 mg phosphatidylcholine capsules obtained from a commercial source.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample sizes within each group created uneven distributions of some baseline characteristics; participants' dietary intake beyond the assigned interventions was not controlled during the study period; using only healthy controls makes the translatability of the results to other patient populations, like those with impaired renal function, unclear.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jennifer Wilcox</name_or_title>
      <organization>Cleveland Clinic Foundation</organization>
      <phone>216-636-6153</phone>
      <email>kirsopj@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03039023
org study id: 16-1048
nct id: NCT03039023
lead sponsor: 
has dmc: No
The investigators are interested in learning more about choline, a nutrient required by the
      body. The body does make some choline, but it does not make enough to support health and the
      rest must be acquired through diet. Eggs, and especially egg yolks, are a major dietary
      source of choline. Choline can also be given as a dietary supplement. Ingestion of choline
      supplements has been linked to an increased concentration of a compound called TMAO
      (trimethylamine N-oxide). Elevated TMAO levels have been linked to higher heart disease risk.
      With this study, the investigators hope to learn whether there is a difference in the way
      your body responds to the ingestion of a choline supplement versus the choline found within
      eggs.
The principal goal for the study is to examine whether there is a difference between the
      ingestion of choline through supplements versus choline found within eggs on plasma TMAO
      levels. The investigators have previously shown that dietary intake of trimethylamines,
      including the choline group of phosphatidylcholine (PC), is mechanistically linked to
      cardiovascular disease risk and that the metabolism of these trimethylamine nutrients in
      humans is modulated by the intestinal microbes (gut microbes). Additionally, extensive animal
      studies link an essential role of gut microbiota to the metabolism of choline and the
      production of metabolites that promote / accelerate atherosclerotic processes. The
      investigators have also recently shown a 10-fold increase in plasma TMAO levels following
      supplementation with choline bitartrate supplements. However, another pilot study by a
      collaborator (unpublished) did not show the same increase in plasma TMAO levels following the
      ingestion of whole eggs, a major dietary source of choline. Therefore, with this study the
      investigators wish to examine the differences, if any, between the ingestion of an equivalent
      mass of total choline in the free form (as bitartrate salt) as a supplement vs. within whole
      eggs.

      Eggs, and specifically the egg yolk, contain a large amount of total choline. However, egg
      white contains potential anti-microbial peptides that could influence gut microbial
      composition and function, and therefore impact conversion of choline into TMA and TMAO
      observed in subjects. Therefore, the investigators hypothesize that the consumption of whole
      eggs (hardboiled) will not elevate plasma TMAO levels to the same extent as a comparable
      amount of total choline ingested in capsule form as the choline bitartrate salt. The
      investigators further hypothesize that the consumption of egg white with choline bitartrate
      tablets may result in less of a rise in TMAO levels than ingestion of the choline bitartrate
      supplement alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite
time frame: Baseline, 28 days
description: Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry.
measure: Changes in Platelet Function With Increased Choline Intake
time frame: Baseline, Day 28
description: The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.
measure: Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections
time frame: Baseline, Day 28
description: Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.
measure: Changes in Plasma Levels of Fasting Choline
time frame: Baseline, Day 28
description: Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.
measure: Changes in Plasma Levels of Fasting Carnitine.
time frame: Baseline, Day 28
description: Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.
measure: Changes in Plasma Levels of Fasting Betaine.
time frame: Baseline, Day 28
description: Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.
measure: Changes in Lipid Profile, Total Cholesterol
time frame: Baseline, Day 28
description: Changes in total cholesterol levels between baseline and Day 28
measure: Changes in Lipid Profile, HDL
time frame: Baseline, Day 28
description: Changes in measured HDL levels between baseline and Day 28
measure: Changes in Lipid Profile, LDL
time frame: Baseline, Day 28
description: Changes in measured LDL levels between baseline and Day 28
measure: Changes in Lipid Profile, Triglycerides
time frame: Baseline, Day 28
description: Changes in measured triglyceride levels between baseline and Day 28
arm group label: Whole Hardboiled Eggs
arm group type: Experimental
description: Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
arm group label: Choline Bitartrate Tablets
arm group type: Experimental
description: Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
arm group label: Hardboiled Eggs + Choline Bitartrate Tablets
arm group type: Experimental
description: Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
arm group label: Egg Whites + Choline Bitartrate Tablets
arm group type: Experimental
description: Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
arm group label: Phosphatidylcholine Capsules
arm group type: Experimental
description: Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
intervention type: Dietary Supplement
intervention name: Choline Bitartrate
description: 500mg choline bitartrate tablets
arm group label: Choline Bitartrate Tablets
arm group label: Egg Whites + Choline Bitartrate Tablets
arm group label: Hardboiled Eggs + Choline Bitartrate Tablets
intervention type: Other
intervention name: Pre-cooked, pre-peeled whole hardboiled eggs
description: Obtained from a commercial source.
arm group label: Hardboiled Eggs + Choline Bitartrate Tablets
arm group label: Whole Hardboiled Eggs
intervention type: Other
intervention name: Egg whites from pre-cooked, pre-peeled hardboiled eggs
description: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
arm group label: Egg Whites + Choline Bitartrate Tablets
intervention type: Dietary Supplement
intervention name: Phosphatidylcholine capsules
description: 420 mg phosphatidylcholine capsules obtained from a commercial source.
arm group label: Phosphatidylcholine Capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: W. H. Wilson Tang, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
url: https://data.nal.usda.gov/system/files/Choln02.pdf
description: Patterson K, Bhagwat S, Williams J, Howe J, and Holden J. USDA Database for the Choline Content of Common Foods, Release Two. January 2008.
citation: Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
PMID: 21475195
citation: Rebouche CJ, Chenard CA. Metabolic fate of dietary carnitine in human adults: identification and quantification of urinary and fecal metabolites. J Nutr. 1991 Apr;121(4):539-46. doi: 10.1093/jn/121.4.539.
PMID: 2007906
citation: Bidulescu A, Chambless LE, Siega-Riz AM, Zeisel SH, Heiss G. Repeatability and measurement error in the assessment of choline and betaine dietary intake: the Atherosclerosis Risk in Communities (ARIC) study. Nutr J. 2009 Feb 20;8:14. doi: 10.1186/1475-2891-8-14.
PMID: 19232103
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Wilson Tang
investigator title: Staff, Cardiovascular Medicine, The Cleveland Clinic; Staff, Cellular and Molecular Medicine, The Cleveland Clinic Lerner Research Institute
mesh term: Choline
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample sizes within each group created uneven distributions of some baseline characteristics; participants' dietary intake beyond the assigned interventions was not controlled during the study period; using only healthy controls makes the translatability of the results to other patient populations, like those with impaired renal function, unclear.
point of contact: 