<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/NCT02188251</url>
  </required_header>
  <id_info>
    <org_study_id>14AWHG</org_study_id>
    <nct_id>NCT02188251</nct_id>
  </id_info>
  <brief_title>A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants</brief_title>
  <acronym>14AWHG</acronym>
  <official_title>A Randomized, Double-blind, Placebo Controlled, Parallel Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KGK Science Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gencor Pacific Limited</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KGK Science Inc.</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of Activamp, a product containing&#xD;
      gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy&#xD;
      overweight adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 2</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>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Baseline to week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in calculated BMI</measure>
    <time_frame>baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in calculated percent body fat</measure>
    <time_frame>Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in calculated body fat mass</measure>
    <time_frame>Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in calculated lean body mass</measure>
    <time_frame>Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total body fat percentage</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>As determined by DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total fat mass</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>As determined by DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total lean mass</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>As determined by DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percent android fat</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>As determined by DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percent gynoid fat</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>As determined by DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percent trunk and legs fat</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>As determined by DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percent abdominal fat</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>As determined by DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anthropometric measurements</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Waist and Hip circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood AMPK activity</measure>
    <time_frame>Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood metabolic parameters</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>lipid profile, Apo A1, Apo B, FFA, insulin and glucose, HOMA-IR, HbA1c, IGF, HsCrp, TNFalpha and glycerol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood safety parameters</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>CBC, electrolytes, markers of kidney and liver function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in safety vital signs</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>Blood pressure, heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Baseline to week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Body Weight</condition>
  <arm_group>
    <arm_group_label>Activamp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 capsule taken twice daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Activamp</intervention_name>
    <arm_group_label>Activamp</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female 21-55 years of age&#xD;
&#xD;
          -  BMI of 25.0 kg/m2 to 29.9 kg/m2 (± 1.0kg/m2)&#xD;
&#xD;
          -  Must have negative urine pregnancy test at screening&#xD;
&#xD;
          -  Female subject of childbearing potential must agree to use a medically approved method&#xD;
             of birth control and have a negative urine pregnancy test result.&#xD;
&#xD;
          -  Subject agrees to maintain their normal level of physical activity throughout the&#xD;
             study&#xD;
&#xD;
          -  Weight has been stable for the last 3 months&#xD;
&#xD;
          -  Subject agrees to comply with study procedures&#xD;
&#xD;
          -  Healthy as determined by laboratory results, medical history and physical exam&#xD;
&#xD;
          -  Subject agrees not to participate in structured activity including resistance training&#xD;
             and aerobic exercise more than 3 times per week&#xD;
&#xD;
          -  Has given voluntary, written, informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, breastfeeding, or planning to become pregnant during the&#xD;
             course of the trial&#xD;
&#xD;
          -  Subject who have experienced a greater than 10% variation in body weight in the past 3&#xD;
             months&#xD;
&#xD;
          -  History of, or current diagnosis of any major diseases of the cardiovascular, hepatic,&#xD;
             renal, gastrointestinal, pulmonary or endocrine systems&#xD;
&#xD;
          -  History of surgery for weight loss (including gastric bypass or lapband)&#xD;
&#xD;
          -  History of conditions that could interfere with the test product or impede its&#xD;
             absorption such as gastrointestinal disease (Crohn's disease) or experienced surgery&#xD;
             (caecum or enterocele surgery)&#xD;
&#xD;
          -  Subjects diagnosed with Type II Diabetes&#xD;
&#xD;
          -  Subjects with active cancer (excluding basal cell carcinoma)&#xD;
&#xD;
          -  Subjects with active eating disorders&#xD;
&#xD;
          -  Subjects who have undergone anti-psychotic drug therapy within the past 2 months&#xD;
&#xD;
          -  Use of prescription or over the counter medications known to affect weight within 3&#xD;
             weeks of randomization or during the study&#xD;
&#xD;
          -  Use of any supplements, programs, or meal replacement products, other than those&#xD;
             provided, intended to alter body weight within two weeks of screening or during the&#xD;
             course of the study&#xD;
&#xD;
          -  Use of illicit drugs or history of drug or alcohol abuse within the past 6 months&#xD;
&#xD;
          -  Currently having more than 2 standard alcoholic drinks per day&#xD;
&#xD;
          -  Participation in a clinical research trial within 30 days prior to randomization&#xD;
&#xD;
          -  Allergy or sensitivity to test article ingredients&#xD;
&#xD;
          -  Individuals who are cognitively impaired and/or who are unable to give informed&#xD;
             consent&#xD;
&#xD;
          -  Abnormal lab test results or any other medical or psychological condition which in the&#xD;
             Investigator's opinion may adversely affect the subject's ability to complete the&#xD;
             study or its measures or which may pose significant risk to the subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dale Wilson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KGK Science Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KGK Synergize Inc.</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>August 11, 2015</last_update_submitted>
  <last_update_submitted_qc>August 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Activamp</keyword>
  <keyword>Gynostemma pentaphyllum</keyword>
  <keyword>Body weight</keyword>
  <keyword>Fat Loss</keyword>
  <keyword>Metabolic markers</keyword>
  <keyword>Overweight participants</keyword>
  <keyword>DXA</keyword>
  <keyword>AMPK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_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/NCT02188251
org study id: 14AWHG
nct id: NCT02188251
lead sponsor: 
collaborator: 
The purpose of this study is to determine the effects of Activamp, a product containing
      gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy
      overweight adults.
allocation: Randomized
intervention model: Parallel Assignment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in body weight
time frame: Baseline to week 12
measure: Change in calculated BMI
time frame: baseline to week 12
measure: Change in calculated percent body fat
time frame: Baseline to week 12
measure: Change in calculated body fat mass
time frame: Baseline to week 12
measure: Change in calculated lean body mass
time frame: Baseline to week 12
measure: Change in total body fat percentage
time frame: Baseline to week 12
description: As determined by DXA scan
measure: Change in total fat mass
time frame: Baseline to week 12
description: As determined by DXA scan
measure: Change in total lean mass
time frame: Baseline to week 12
description: As determined by DXA scan
measure: Change in percent android fat
time frame: Baseline to week 12
description: As determined by DXA scan
measure: Change in percent gynoid fat
time frame: Baseline to week 12
description: As determined by DXA scan
measure: Change in percent trunk and legs fat
time frame: Baseline to week 12
description: As determined by DXA scan
measure: Change in percent abdominal fat
time frame: Baseline to week 12
description: As determined by DXA scan
measure: Change in anthropometric measurements
time frame: Baseline to 12 weeks
description: Waist and Hip circumference
measure: Change in blood AMPK activity
time frame: Baseline to week 12
measure: Change in blood metabolic parameters
time frame: Baseline to 12 weeks
description: lipid profile, Apo A1, Apo B, FFA, insulin and glucose, HOMA-IR, HbA1c, IGF, HsCrp, TNFalpha and glycerol
measure: Change in blood safety parameters
time frame: Baseline to week 12
description: CBC, electrolytes, markers of kidney and liver function
measure: Changes in safety vital signs
time frame: Baseline to week 12
description: Blood pressure, heart rate
measure: Incidence of adverse events
time frame: Baseline to week 12
arm group label: Activamp
arm group type: Experimental
description: Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: 1 capsule taken twice daily for 12 weeks
intervention type: Dietary Supplement
intervention name: Activamp
arm group label: Activamp
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dale Wilson, MD
role: Principal Investigator
affiliation: KGK Science Inc.
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Overweight
mesh term: Body Weight