Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants (14AWHG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188251
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : August 13, 2015
Sponsor:
Collaborator:
Gencor Pacific Limited
Information provided by (Responsible Party):
KGK Science Inc.

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Change in body weight [ Time Frame: Baseline to week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • Change in calculated BMI [ Time Frame: baseline to week 12 ]
  • Change in calculated percent body fat [ Time Frame: Baseline to week 12 ]
  • Change in calculated body fat mass [ Time Frame: Baseline to week 12 ]
  • Change in calculated lean body mass [ Time Frame: Baseline to week 12 ]
  • Change in total body fat percentage [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
  • Change in total fat mass [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
  • Change in total lean mass [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
  • Change in percent android fat [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
  • Change in percent gynoid fat [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
  • Change in percent trunk and legs fat [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
  • Change in percent abdominal fat [ Time Frame: Baseline to week 12 ]
    As determined by DXA scan
  • Change in anthropometric measurements [ Time Frame: Baseline to 12 weeks ]
    Waist and Hip circumference
  • Change in blood AMPK activity [ Time Frame: Baseline to week 12 ]
  • Change in blood metabolic parameters [ Time Frame: Baseline to 12 weeks ]
    lipid profile, Apo A1, Apo B, FFA, insulin and glucose, HOMA-IR, HbA1c, IGF, HsCrp, TNFalpha and glycerol
  • Change in blood safety parameters [ Time Frame: Baseline to week 12 ]
    CBC, electrolytes, markers of kidney and liver function
  • Changes in safety vital signs [ Time Frame: Baseline to week 12 ]
    Blood pressure, heart rate
  • Incidence of adverse events [ Time Frame: Baseline to week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Body Weight
Intervention  ICMJE
  • Dietary Supplement: Activamp
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Activamp
    Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks
    Intervention: Dietary Supplement: Activamp
  • Placebo Comparator: Placebo
    1 capsule taken twice daily for 12 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female 21-55 years of age
  • BMI of 25.0 kg/m2 to 29.9 kg/m2 (± 1.0kg/m2)
  • Must have negative urine pregnancy test at screening
  • Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
  • Subject agrees to maintain their normal level of physical activity throughout the study
  • Weight has been stable for the last 3 months
  • Subject agrees to comply with study procedures
  • Healthy as determined by laboratory results, medical history and physical exam
  • Subject agrees not to participate in structured activity including resistance training and aerobic exercise more than 3 times per week
  • Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
  • Subject who have experienced a greater than 10% variation in body weight in the past 3 months
  • History of, or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
  • History of surgery for weight loss (including gastric bypass or lapband)
  • History of conditions that could interfere with the test product or impede its absorption such as gastrointestinal disease (Crohn's disease) or experienced surgery (caecum or enterocele surgery)
  • Subjects diagnosed with Type II Diabetes
  • Subjects with active cancer (excluding basal cell carcinoma)
  • Subjects with active eating disorders
  • Subjects who have undergone anti-psychotic drug therapy within the past 2 months
  • Use of prescription or over the counter medications known to affect weight within 3 weeks of randomization or during the study
  • Use of any supplements, programs, or meal replacement products, other than those provided, intended to alter body weight within two weeks of screening or during the course of the study
  • Use of illicit drugs or history of drug or alcohol abuse within the past 6 months
  • Currently having more than 2 standard alcoholic drinks per day
  • Participation in a clinical research trial within 30 days prior to randomization
  • Allergy or sensitivity to test article ingredients
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Abnormal lab test results or any other medical or psychological condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188251
Other Study ID Numbers  ICMJE 14AWHG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KGK Science Inc.
Study Sponsor  ICMJE KGK Science Inc.
Collaborators  ICMJE Gencor Pacific Limited
Investigators  ICMJE
Principal Investigator: Dale Wilson, MD KGK Science Inc.
PRS Account KGK Science Inc.
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP