<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/NCT02184832</url>
  </required_header>
  <id_info>
    <org_study_id>2014P001226</org_study_id>
    <nct_id>NCT02184832</nct_id>
  </id_info>
  <brief_title>Dietary Intake of Tryptophan and Metformin Response</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the influence of dietary intake of tryptophan on response to&#xD;
      metformin. The investigators hypothesize that dietary tryptophan alteration will influence&#xD;
      metformin response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Early Phase 1</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in fasting glucose</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in tryptophan concentration</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>tolerability of dietary tryptophan alteration</measure>
    <time_frame>2 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Metformin Response</condition>
  <condition>Fasting Glucose</condition>
  <condition>Tryptophan Concentration</condition>
  <condition>Metformin Concentration</condition>
  <condition>Diet Tolerability</condition>
  <arm_group>
    <arm_group_label>Low tryptophan diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 days of a low tryptophan diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High tryptophan diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 days of a high tryptophan diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>2 doses of 500 mg metformin given approximately 12 hrs apart</description>
    <arm_group_label>High tryptophan diet</arm_group_label>
    <arm_group_label>Low tryptophan diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low tryptophan diet</intervention_name>
    <arm_group_label>Low tryptophan diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High tryptophan diet</intervention_name>
    <arm_group_label>High tryptophan diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. healthy adult male or non-pregnant female volunteers (age 20-40)&#xD;
&#xD;
          2. able and willing to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 20 or greater than 40&#xD;
&#xD;
          2. Women who are pregnant, nursing, or at risk of becoming pregnant&#xD;
&#xD;
          3. Body mass index (BMI) less than 20 or greater than 28&#xD;
&#xD;
          4. Changes of more than 5 pounds in weight (increase or decrease) during the month prior&#xD;
             to enrollment in the study&#xD;
&#xD;
          5. Participation in more than 300 minutes of exercise per week during the month prior to&#xD;
             enrollment in the study&#xD;
&#xD;
          6. Known diabetes or pre-diabetes (based on prior diagnoses, use of medications to lower&#xD;
             glucose; or fasting blood glucose &gt; 100mg/dL at screening)&#xD;
&#xD;
          7. Untreated hypertension (defined as systolic blood pressure &gt; 140mmHg and diastolic&#xD;
             blood pressure &gt; 90mmHg)&#xD;
&#xD;
          8. Current or past mood disorder, including major depression, anxiety, or bipolar&#xD;
             disorder&#xD;
&#xD;
          9. Conditions causing intestinal malabsorption, including celiac disease or a history of&#xD;
             intestinal or gastric bypass surgery&#xD;
&#xD;
         10. History of liver disease and/or aspartate aminotransferase (AST) or alanine&#xD;
             aminotransferase (ALT) more than 3 times upper limit of normal (ULN)&#xD;
&#xD;
         11. Estimated glomerular filtration rate (eGFR) &lt; 60 ml/min/1.73 m2 as calculated by the&#xD;
             Modification of Diet in Renal Disease equation&#xD;
&#xD;
         12. Currently taking or intending to take during the study duration any medication known&#xD;
             to affect glycemic parameters, such as glucocorticoids, growth hormone, or&#xD;
             fluoroquinolones&#xD;
&#xD;
         13. Use of medications and herbal or vitamin supplements during the study&#xD;
&#xD;
         14. Contraindications to safe use of metformin, including planned radiologic or&#xD;
             angiographic study requiring contrast within one week of the study completion&#xD;
&#xD;
         15. Objection to taking metformin&#xD;
&#xD;
         16. Participation in any other interventional study during the study duration&#xD;
&#xD;
         17. Use of nicotine-containing products, including inhaled, chewed, or patches during the&#xD;
             study.&#xD;
&#xD;
         18. Use of drugs of abuse.&#xD;
&#xD;
         19. Restrictions that prevent adherence to standardized meals or unwillingness to adhere&#xD;
             to a pre-specified meal plan, including abstinence from alcohol and limitation of&#xD;
             caffeine intake to one drink daily.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geoffrey Walford, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 14, 2016</last_update_submitted>
  <last_update_submitted_qc>March 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Geoffrey Walford, MD</investigator_full_name>
    <investigator_title>Instructor in Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Tryptophan</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02184832
org study id: 2014P001226
nct id: NCT02184832
lead sponsor: 
has dmc: No
This study will examine the influence of dietary intake of tryptophan on response to
      metformin. The investigators hypothesize that dietary tryptophan alteration will influence
      metformin response.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: change in fasting glucose
time frame: 2 days
measure: change in tryptophan concentration
time frame: 2 days
measure: tolerability of dietary tryptophan alteration
time frame: 2 days
arm group label: Low tryptophan diet
arm group type: Experimental
description: 2 days of a low tryptophan diet
arm group label: High tryptophan diet
arm group type: Experimental
description: 2 days of a high tryptophan diet
intervention type: Drug
intervention name: Metformin
description: 2 doses of 500 mg metformin given approximately 12 hrs apart
arm group label: High tryptophan diet
arm group label: Low tryptophan diet
intervention type: Other
intervention name: Low tryptophan diet
arm group label: Low tryptophan diet
intervention type: Other
intervention name: High tryptophan diet
arm group label: High tryptophan diet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Geoffrey Walford, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Geoffrey Walford, MD
investigator title: Instructor in Medicine
mesh term: Metformin
mesh term: Tryptophan