<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/NCT02987868</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 10043 - HGH/Somatostatin</org_study_id>
    <nct_id>NCT02987868</nct_id>
  </id_info>
  <brief_title>Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine</brief_title>
  <official_title>Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH)&#xD;
      increased 682% above baseline 120 minutes after oral administration of an amino acid-based&#xD;
      dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH&#xD;
      stimulation by ghrelin, the investigators hypothesize that the supplement suppresses&#xD;
      somatostatin, a know inhibitor of both hGH and TSH. To test this hypothesis, the&#xD;
      investigators measured triiodothyronine (T3) after administration of the amino acid-base&#xD;
      supplement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two molecular targets that regulate the synthesis and secretion of human growth hormone (hGH)&#xD;
      include 1) ghrelin, an endogenous ligand secreted by the stomach that also has&#xD;
      appetite-stimulation properties distinct from its hGH-stimulating effects, and 2)&#xD;
      somatostatin, a family of 14 and 28 amino acid peptides that act as a potent noncompetitive&#xD;
      inhibitor of the release of hGH. the investigators recently reported that oral administration&#xD;
      of a 2.9g/dose of SeroVital, a blend of l-lysine HCl, l-arginine HCL, oxo-proline,&#xD;
      N-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerial parts) powder, leads to a&#xD;
      significant 682% mean increase in endogenous hGH levels in male and female subjects in a&#xD;
      period of 120 minutes following acute consumption. In the work presented here, the&#xD;
      investigators seek to characterize the mechanistic target associated with this measured&#xD;
      increase in endogenous hGH by SeroVital, which the investigators hypothesize to be&#xD;
      somatostatin. The investigators test this hypothesis by assaying thyroid function, a&#xD;
      secondary inhibition target of somatostatin. The investigators further compare our findings&#xD;
      to ghrelin-based hGH secretagogues.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change of Triiodthyronine Over Baseline</measure>
    <time_frame>0-120 minutes, at Baseline and post dose, week 1 and week 3</time_frame>
    <description>Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Growth Hormone Treatment</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Supplement 1st day, placebo 2nd day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of oral supplement (proprietary amino acid derivative blend). Half of the participants took the Amino acid supplement first day and half of the participants took the Amino acid supplement second day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 1st day, supplement 2nd day</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Half of the participants took the placebo first day and half of the participants took placebo second day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amino acid supplement first day</intervention_name>
    <description>An orally administered supplement of the proprietary amino acid derivative</description>
    <arm_group_label>Supplement 1st day, placebo 2nd day</arm_group_label>
    <other_name>SeroVital™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo first day</intervention_name>
    <description>A non-active orally administered supplement of the proprietary amino acid derivative</description>
    <arm_group_label>Placebo 1st day, supplement 2nd day</arm_group_label>
    <other_name>Non-active</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amino acid supplement second day</intervention_name>
    <description>An orally administered supplement of the proprietary amino acid derivative</description>
    <arm_group_label>Placebo 1st day, supplement 2nd day</arm_group_label>
    <other_name>SeroVital™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo second day</intervention_name>
    <description>A non-active orally administered supplement of the proprietary amino acid derivative</description>
    <arm_group_label>Supplement 1st day, placebo 2nd day</arm_group_label>
    <other_name>Non-active</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12 healthy males and 4 healthy females&#xD;
&#xD;
          -  Between 18 and 70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Taking any chronic medication including birth control pills.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Greenway, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>October 3, 2017</results_first_submitted>
  <results_first_submitted_qc>February 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2018</results_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</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>
  <keyword>Somatostatin</keyword>
  <keyword>Thyroid Hormone</keyword>
  <keyword>Growth Hormone</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.</recruitment_details>
      <pre_assignment_details>16 participants recruited; 16 Screened, 0 excluded (12 Males and 4 Females)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Amino Acid Supplement First, Then Placebo</title>
          <description>An orally administered amino acid supplement first, and after washout period, placebo.&#xD;
Placebo: A non-active orally administered supplement of the proprietary amino acid derivative&#xD;
Amino acid supplement: Supplements with the proprietary amino acid derivative blend.</description>
        </group>
        <group group_id="P2">
          <title>Placebo First, Then Amino Acid Supplement</title>
          <description>Non-active Placebo first, and after washout period, an orally administered amino acid supplement.&#xD;
Placebo: A non-active orally administered supplement of the proprietary amino acid derivative&#xD;
Amino acid supplement: Supplements with the proprietary amino acid derivative blend.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Wash Out Period 1 Week</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Supplements with the proprietary amino acid derivative blend.&#xD;
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23" spread="14"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change of Triiodthyronine Over Baseline</title>
        <description>Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.</description>
        <time_frame>0-120 minutes, at Baseline and post dose, week 1 and week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Amino Acid Supplement</title>
            <description>Supplements with the proprietary amino acid derivative blend.&#xD;
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Non-active&#xD;
Placebo: A non-active orally administered supplement of the proprietary amino acid derivative</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change of Triiodthyronine Over Baseline</title>
          <description>Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="10.3"/>
                    <measurement group_id="O2" value="-6.1" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Amino Acid Supplement</title>
          <description>Supplements with the proprietary amino acid derivative blend.&#xD;
Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Non-active&#xD;
Placebo: A non-active orally administered supplement of the proprietary amino acid derivative</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Dr. Frank Greenway, Chief of Outpatient Clinic</name_or_title>
      <organization>Pennington Biomedical Research Center</organization>
      <phone>225-763-2578</phone>
      <email>Frank.Greenway@pbrc.edu</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/NCT02987868
org study id: PBRC 10043 - HGH/Somatostatin
nct id: NCT02987868
lead sponsor: 
has dmc: No
In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH)
      increased 682% above baseline 120 minutes after oral administration of an amino acid-based
      dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH
      stimulation by ghrelin, the investigators hypothesize that the supplement suppresses
      somatostatin, a know inhibitor of both hGH and TSH. To test this hypothesis, the
      investigators measured triiodothyronine (T3) after administration of the amino acid-base
      supplement.
Two molecular targets that regulate the synthesis and secretion of human growth hormone (hGH)
      include 1) ghrelin, an endogenous ligand secreted by the stomach that also has
      appetite-stimulation properties distinct from its hGH-stimulating effects, and 2)
      somatostatin, a family of 14 and 28 amino acid peptides that act as a potent noncompetitive
      inhibitor of the release of hGH. the investigators recently reported that oral administration
      of a 2.9g/dose of SeroVital, a blend of l-lysine HCl, l-arginine HCL, oxo-proline,
      N-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerial parts) powder, leads to a
      significant 682% mean increase in endogenous hGH levels in male and female subjects in a
      period of 120 minutes following acute consumption. In the work presented here, the
      investigators seek to characterize the mechanistic target associated with this measured
      increase in endogenous hGH by SeroVital, which the investigators hypothesize to be
      somatostatin. The investigators test this hypothesis by assaying thyroid function, a
      secondary inhibition target of somatostatin. The investigators further compare our findings
      to ghrelin-based hGH secretagogues.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percent Change of Triiodthyronine Over Baseline
time frame: 0-120 minutes, at Baseline and post dose, week 1 and week 3
description: Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.
arm group label: Supplement 1st day, placebo 2nd day
arm group type: Active Comparator
description: Administration of oral supplement (proprietary amino acid derivative blend). Half of the participants took the Amino acid supplement first day and half of the participants took the Amino acid supplement second day.
arm group label: Placebo 1st day, supplement 2nd day
arm group type: Placebo Comparator
description: Half of the participants took the placebo first day and half of the participants took placebo second day.
intervention type: Drug
intervention name: Amino acid supplement first day
description: An orally administered supplement of the proprietary amino acid derivative
arm group label: Supplement 1st day, placebo 2nd day
other name: SeroVital™
intervention type: Drug
intervention name: Placebo first day
description: A non-active orally administered supplement of the proprietary amino acid derivative
arm group label: Placebo 1st day, supplement 2nd day
other name: Non-active
intervention type: Drug
intervention name: Amino acid supplement second day
description: An orally administered supplement of the proprietary amino acid derivative
arm group label: Placebo 1st day, supplement 2nd day
other name: SeroVital™
intervention type: Drug
intervention name: Placebo second day
description: A non-active orally administered supplement of the proprietary amino acid derivative
arm group label: Supplement 1st day, placebo 2nd day
other name: Non-active
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frank Greenway, M.D.
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Frank Greenway
investigator title: Principal Investigator
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 