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| Name | Class |
|---|---|
| Gencor Pacific Limited, Hong Kong | INDUSTRY |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activamp | Experimental | Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks |
|
| Placebo | Placebo Comparator | 1 capsule taken twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activamp | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Baseline to week 12 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Wilson, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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 |