<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/NCT01710722</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 20034</org_study_id>
    <nct_id>NCT01710722</nct_id>
  </id_info>
  <brief_title>The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man</brief_title>
  <official_title>The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare three treatments to see which causes the most weight&#xD;
      loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three treatments are compared to see which causes the most weight loss, fat loss, loss of&#xD;
      stomach fat and improvement in blood tests like cholesterol.&#xD;
&#xD;
      1) Leptin A-200 injections daily with 2 inactive pills taken three times a day, 2) Caffeine&#xD;
      with ephedrine pills taken 3 times a day with an inactive injection daily and 3) Both Leptin&#xD;
      A-200 injections daily and caffeine with ephedrine pills taken three times a day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2001</start_date>
  <completion_date type="Actual">February 2002</completion_date>
  <primary_completion_date type="Actual">February 2002</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine.</measure>
    <time_frame>28 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the loss of fat and lean tissue with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the loss of fat and lean tissue with caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare weight loss with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare weight loss caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare weight loss with leptin, ephedrine and caffeine combination.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in insulin, with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in insulin, with caffeine with ephedrine alone</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in insulin, with leptin , ephedrine and caffeine combination.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in triglycerides, with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in triglycerides, caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in cholesterol, with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in cholesterol, caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in cholesterol with leptin , ephedrine and caffeine combination</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in HDL cholesterol, with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in HDL cholesterol, caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in LDL cholesterol, with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in LDL cholesterol, caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in glucose, with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in glucose, caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in glucose, with leptin , ephedrine and caffeine combination</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in uric acid, with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in uric acid, caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in uric acid, with leptin , ephedrine and caffeine combination</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in Alanine Aminotransferase (ALT )with leptin alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone.</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>caffeine and ephedrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>leptin A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>caffeine, ephedrine, and leptin A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>caffeine and ephedrine</intervention_name>
    <description>Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.</description>
    <arm_group_label>caffeine and ephedrine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leptin A</intervention_name>
    <description>Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.</description>
    <arm_group_label>leptin A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>caffeine, ephedrine, and leptin A</intervention_name>
    <description>Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.</description>
    <arm_group_label>caffeine, ephedrine, and leptin A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  You are healthy.&#xD;
&#xD;
          -  You are not pregnant or nursing.&#xD;
&#xD;
          -  You are between 18 and 60 years of age.&#xD;
&#xD;
          -  You have a body mass index, calculated from your height and weight, of 30 to 40 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  You take chronic medications except hormone replacement or contraception.&#xD;
&#xD;
          -  You are a woman and are unwilling to use effective contraception during the trial.&#xD;
&#xD;
          -  You have blood pressure higher than 150/90.&#xD;
&#xD;
          -  You have heart disease.&#xD;
&#xD;
          -  You have urinary symptoms from an enlarged prostate.&#xD;
&#xD;
          -  You have gained or lost more than 10 pounds in the last 6 months.&#xD;
&#xD;
          -  You have used a monoamine oxidase inhibitor medication in the last month.&#xD;
&#xD;
          -  You have high or low thyroid function that has not been controlled in the normal range&#xD;
             for at least 2 months.&#xD;
&#xD;
          -  You have heart disease or a history of stroke.&#xD;
&#xD;
          -  You have a known sensitivity to E. coli or E. coli derived products.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>December 17, 2015</last_update_submitted>
  <last_update_submitted_qc>December 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Frank Greenway</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ephedrine</mesh_term>
    <mesh_term>Pseudoephedrine</mesh_term>
    <mesh_term>Caffeine</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/NCT01710722
org study id: PBRC 20034
nct id: NCT01710722
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare three treatments to see which causes the most weight
      loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.
Three treatments are compared to see which causes the most weight loss, fat loss, loss of
      stomach fat and improvement in blood tests like cholesterol.

      1) Leptin A-200 injections daily with 2 inactive pills taken three times a day, 2) Caffeine
      with ephedrine pills taken 3 times a day with an inactive injection daily and 3) Both Leptin
      A-200 injections daily and caffeine with ephedrine pills taken three times a day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine.
time frame: 28 weeks
measure: Compare the loss of fat and lean tissue with leptin alone.
time frame: 28 Weeks
measure: To compare the loss of fat and lean tissue with caffeine with ephedrine alone.
time frame: 28 Weeks
measure: compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination.
time frame: 28 Weeks
measure: To compare weight loss with leptin alone.
time frame: 28 Weeks
measure: To compare weight loss caffeine with ephedrine alone.
time frame: 28 Weeks
measure: To compare weight loss with leptin, ephedrine and caffeine combination.
time frame: 28 Weeks
measure: To compare the changes in insulin, with leptin alone.
time frame: 28 Weeks
measure: To compare the changes in insulin, with caffeine with ephedrine alone
time frame: 28 Weeks
measure: To compare the changes in insulin, with leptin , ephedrine and caffeine combination.
time frame: 28 Weeks
measure: To compare the changes in triglycerides, with leptin alone.
time frame: 28 Weeks
measure: To compare the changes in triglycerides, caffeine with ephedrine alone.
time frame: 28 Weeks
measure: To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination
time frame: 28 Weeks
measure: To compare the changes in cholesterol, with leptin alone.
time frame: 28 Weeks
measure: To compare the changes in cholesterol, caffeine with ephedrine alone.
time frame: 28 Weeks
measure: To compare the changes in cholesterol with leptin , ephedrine and caffeine combination
time frame: 28 Weeks
measure: To compare the changes in HDL cholesterol, with leptin alone.
time frame: 28 Weeks
measure: To compare the changes in HDL cholesterol, caffeine with ephedrine alone.
time frame: 28 Weeks
measure: To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination
time frame: 28 Weeks
measure: To compare the changes in LDL cholesterol, with leptin alone.
time frame: 28 Weeks
measure: To compare the changes in LDL cholesterol, caffeine with ephedrine alone.
time frame: 28 Weeks
measure: To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination
time frame: 28 Weeks
measure: To compare the changes in glucose, with leptin alone.
time frame: 28 Weeks
measure: To compare the changes in glucose, caffeine with ephedrine alone.
time frame: 28 Weeks
measure: To compare the changes in glucose, with leptin , ephedrine and caffeine combination
time frame: 28 Weeks
measure: To compare the changes in uric acid, with leptin alone.
time frame: 28 Weeks
measure: To compare the changes in uric acid, caffeine with ephedrine alone.
time frame: 28 Weeks
measure: To compare the changes in uric acid, with leptin , ephedrine and caffeine combination
time frame: 28 Weeks
measure: To compare the changes in Alanine Aminotransferase (ALT )with leptin alone.
time frame: 28 Weeks
measure: To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone.
time frame: 28 Weeks
measure: To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination
time frame: 28 Weeks
arm group label: caffeine and ephedrine
arm group type: Experimental
description: Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.
arm group label: leptin A
arm group type: Experimental
description: Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.
arm group label: caffeine, ephedrine, and leptin A
arm group type: Experimental
description: Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.
intervention type: Drug
intervention name: caffeine and ephedrine
description: Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.
arm group label: caffeine and ephedrine
intervention type: Drug
intervention name: Leptin A
description: Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.
arm group label: leptin A
intervention type: Drug
intervention name: caffeine, ephedrine, and leptin A
description: Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.
arm group label: caffeine, ephedrine, and leptin A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Frank Greenway
investigator title: Principal Investigator
mesh term: Weight Loss
mesh term: Ephedrine
mesh term: Pseudoephedrine
mesh term: Caffeine