Clinical trial NCT02188251: A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Body Weight
Keywords: Activamp
Gynostemma pentaphyllum
Body weight
Fat Loss
Metabolic markers
Overweight participants
DXA
AMPK
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gencor Pacific Limited
First posted: 2014-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Change in calculated BMI
timeFrame: baseline to week 12
measure: Change in calculated percent body fat
timeFrame: Baseline to week 12
measure: Change in calculated body fat mass
timeFrame: Baseline to week 12
measure: Change in calculated lean body mass
timeFrame: Baseline to week 12
measure: Change in total body fat percentage
timeFrame: Baseline to week 12
measure: Change in total fat mass
timeFrame: Baseline to week 12
measure: Change in total lean mass
timeFrame: Baseline to week 12
measure: Change in percent android fat
timeFrame: Baseline to week 12
measure: Change in percent gynoid fat
timeFrame: Baseline to week 12
measure: Change in percent trunk and legs fat
timeFrame: Baseline to week 12
measure: Change in percent abdominal fat
timeFrame: Baseline to week 12
measure: Change in anthropometric measurements
timeFrame: Baseline to 12 weeks
measure: Change in blood AMPK activity
timeFrame: Baseline to week 12
measure: Change in blood metabolic parameters
timeFrame: Baseline to 12 weeks
measure: Change in blood safety parameters
timeFrame: Baseline to week 12
measure: Changes in safety vital signs
timeFrame: Baseline to week 12
measure: Incidence of adverse events
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Dale Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: