<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/NCT04417218</url>
  </required_header>
  <id_info>
    <org_study_id>200427</org_study_id>
    <secondary_id>R01DK117144</secondary_id>
    <nct_id>NCT04417218</nct_id>
  </id_info>
  <brief_title>Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2</brief_title>
  <official_title>Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the effect of controlled dietary lysine intake on plasma and urine&#xD;
      α-aminoadipic acid (2-AAA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes is an important health concern worldwide. It is associated with significantly&#xD;
      increased mortality as well as high incidence of co-morbidities. Unfortunately, treatment&#xD;
      efficacy and successful disease management is highly variable among treated patients, and&#xD;
      this is partly due to the fact that diabetes has multiple underlying causes most of which are&#xD;
      still unknown. A newly identified biomarker, α-aminoadipic acid (2-AAA), has the potential to&#xD;
      successfully predict the development of diabetes in humans, even before the development of&#xD;
      other known risk markers. However, little is known about the function of 2-AAA; it is unclear&#xD;
      whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered&#xD;
      metabolic processes that then lead to diabetes.&#xD;
&#xD;
      The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy&#xD;
      individuals from the general population to identify subjects with high or low 2-AAA. Now in&#xD;
      the second phase of the study, 80 subjects with high or low 2-AAA will be invited to&#xD;
      participate in a dietary lysine modification study to access the effect of controlled lysine&#xD;
      intake on plasma and urine 2AAA. Participants will be asked to complete two one-week dietary&#xD;
      interventions. Subjects will be screened and consented via email, online, or phone. Each&#xD;
      subject will be required to come to Vanderbilt University Medical Center for four study&#xD;
      visits, at which the study team will obtain a blood sample, a urine sample, stool sample,&#xD;
      vital signs, waist and hip circumference, and 1-3 surveys will be completed if the subject&#xD;
      did not complete them prior to the visit. Each subject that completes the entire study visit&#xD;
      will be compensated $250. DNA samples will be obtained to allow for identification of genetic&#xD;
      predictors of 2-AAA levels. Some individuals may be asked to return for a future follow-up&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">January 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Plasma 2-AAA concentration from baseline</measure>
    <time_frame>Baseline, Post-diet 1 (1 week), Pre-diet 2 (3 weeks), Post-diet 2 (4 weeks)</time_frame>
    <description>Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Normal Lysine Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Lysine Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lysine</intervention_name>
    <description>Lysine is an essential amino acid which is acquired from dietary sources.</description>
    <arm_group_label>High Lysine Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Controlled Diet</intervention_name>
    <description>Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.</description>
    <arm_group_label>High Lysine Diet</arm_group_label>
    <arm_group_label>Normal Lysine Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior participant in 2-AAA screening study.&#xD;
&#xD;
          -  Identified as eligible due to high or low plasma 2-AAA, in the absence of&#xD;
             hyperglycemia, as defined by study team.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who currently use tobacco products.&#xD;
&#xD;
          -  Use of prescription or over-the-counter medications or dietary supplements which could&#xD;
             modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to&#xD;
             first study visit until completion of study). Hormonal birth control is acceptable.&#xD;
&#xD;
          -  Follow a severely restricted diet or have food allergies, which would preclude&#xD;
             adherence to study diet.&#xD;
&#xD;
          -  Newly diagnosed disease (since screening visit), including cardiovascular, renal, or&#xD;
             liver disease, or Diabetes mellitus.&#xD;
&#xD;
          -  Individuals who are pregnant or lactating&#xD;
&#xD;
          -  Inability to provide written or electronic informed consent&#xD;
&#xD;
          -  Inability to fast for 8 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Jane Ferguson</investigator_full_name>
    <investigator_title>Assistant Professor, Cardiovascular Medicine Division</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 3, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04417218/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04417218
org study id: 200427
secondary id: R01DK117144
nct id: NCT04417218
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to assess the effect of controlled dietary lysine intake on plasma and urine
      α-aminoadipic acid (2-AAA).
Diabetes is an important health concern worldwide. It is associated with significantly
      increased mortality as well as high incidence of co-morbidities. Unfortunately, treatment
      efficacy and successful disease management is highly variable among treated patients, and
      this is partly due to the fact that diabetes has multiple underlying causes most of which are
      still unknown. A newly identified biomarker, α-aminoadipic acid (2-AAA), has the potential to
      successfully predict the development of diabetes in humans, even before the development of
      other known risk markers. However, little is known about the function of 2-AAA; it is unclear
      whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered
      metabolic processes that then lead to diabetes.

      The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy
      individuals from the general population to identify subjects with high or low 2-AAA. Now in
      the second phase of the study, 80 subjects with high or low 2-AAA will be invited to
      participate in a dietary lysine modification study to access the effect of controlled lysine
      intake on plasma and urine 2AAA. Participants will be asked to complete two one-week dietary
      interventions. Subjects will be screened and consented via email, online, or phone. Each
      subject will be required to come to Vanderbilt University Medical Center for four study
      visits, at which the study team will obtain a blood sample, a urine sample, stool sample,
      vital signs, waist and hip circumference, and 1-3 surveys will be completed if the subject
      did not complete them prior to the visit. Each subject that completes the entire study visit
      will be compensated $250. DNA samples will be obtained to allow for identification of genetic
      predictors of 2-AAA levels. Some individuals may be asked to return for a future follow-up
      study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Plasma 2-AAA concentration from baseline
time frame: Baseline, Post-diet 1 (1 week), Pre-diet 2 (3 weeks), Post-diet 2 (4 weeks)
description: Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard
arm group label: Normal Lysine Diet
arm group type: Experimental
description: Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period.
arm group label: High Lysine Diet
arm group type: Experimental
description: Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day).
intervention type: Dietary Supplement
intervention name: Lysine
description: Lysine is an essential amino acid which is acquired from dietary sources.
arm group label: High Lysine Diet
intervention type: Dietary Supplement
intervention name: Controlled Diet
description: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.
arm group label: High Lysine Diet
arm group label: Normal Lysine Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Jane Ferguson
investigator title: Assistant Professor, Cardiovascular Medicine Division
sharing ipd: No
provided document: 