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Completed

NCT Number: NCT02188251

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

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.

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activamp

Dietary Supplement

Placebo

Other

Primary outcomes

  1. Change in body weight

    Time frame: Baseline to week 12

Secondary outcomes

  1. Change in calculated BMI

    Time frame: baseline to week 12

  2. Change in calculated percent body fat

    Time frame: Baseline to week 12

  3. Change in calculated body fat mass

    Time frame: Baseline to week 12

  4. Change in calculated lean body mass

    Time frame: Baseline to week 12

  5. Change in total body fat percentage

    Time frame: Baseline to week 12

    As determined by DXA scan

  6. Change in total fat mass

    Time frame: Baseline to week 12

    As determined by DXA scan

  7. Change in total lean mass

    Time frame: Baseline to week 12

    As determined by DXA scan

  8. Change in percent android fat

    Time frame: Baseline to week 12

    As determined by DXA scan

  9. Change in percent gynoid fat

    Time frame: Baseline to week 12

    As determined by DXA scan

  10. Change in percent trunk and legs fat

    Time frame: Baseline to week 12

    As determined by DXA scan

  11. Change in percent abdominal fat

    Time frame: Baseline to week 12

    As determined by DXA scan

  12. Change in anthropometric measurements

    Time frame: Baseline to 12 weeks

    Waist and Hip circumference

  13. Change in blood AMPK activity

    Time frame: Baseline to week 12

  14. 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

  15. Change in blood safety parameters

    Time frame: Baseline to week 12

    CBC, electrolytes, markers of kidney and liver function

  16. Changes in safety vital signs

    Time frame: Baseline to week 12

    Blood pressure, heart rate

  17. Incidence of adverse events

    Time frame: Baseline to week 12

Sponsors and collaborators

Lead sponsor

KGK Science Inc.

Industry

Collaborators

  • Gencor Pacific Limited, Hong Kong

Registry information

Official study 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

Acronym: 14AWHG

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2014
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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