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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Body Weight

Intervention / Treatment
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* Dietary Supplement: Activamp
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activamp<br>Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks | Dietary Supplement: Activamp<br> <br> |
| Placebo Comparator: Placebo<br>1 capsule taken twice daily for 12 weeks | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in calculated BMI |  | baseline to week 12 | 
| Change in calculated percent body fat |  | Baseline to week 12 | 
| Change in calculated body fat mass |  | Baseline to week 12 | 
| Change in calculated lean body mass |  | Baseline to week 12 | 
| Change in total body fat percentage | As determined by DXA scan | Baseline to week 12 | 
| Change in total fat mass | As determined by DXA scan | Baseline to week 12 | 
| Change in total lean mass | As determined by DXA scan | Baseline to week 12 | 
| Change in percent android fat | As determined by DXA scan | Baseline to week 12 | 
| Change in percent gynoid fat | As determined by DXA scan | Baseline to week 12 | 
| Change in percent trunk and legs fat | As determined by DXA scan | Baseline to week 12 | 
| Change in percent abdominal fat | As determined by DXA scan | Baseline to week 12 | 
| Change in anthropometric measurements | Waist and Hip circumference | Baseline to 12 weeks | 
| Change in blood AMPK activity |  | Baseline to week 12 | 
| Change in blood metabolic parameters | lipid profile, Apo A1, Apo B, FFA, insulin and glucose, HOMA-IR, HbA1c, IGF, HsCrp, TNFalpha and glycerol | Baseline to 12 weeks | 
| Change in blood safety parameters | CBC, electrolytes, markers of kidney and liver function | Baseline to week 12 | 
| Changes in safety vital signs | Blood pressure, heart rate | Baseline to week 12 | 
| Incidence of adverse events |  | Baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fat Loss, DXA, Activamp, Gynostemma pentaphyllum, Body weight, Metabolic markers, Overweight participants, AMPK