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| Name | Class |
|---|---|
| LifeVantage | UNKNOWN |
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Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress.
Evaluate the effects of Protandim on protein profile changes and markers of inflammation and oxidation in subjects (40-60 years of age) with the Metabolic Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protandim | Active Comparator | one capsule a day for 30 days of protandim given, followed by a wash out period. |
|
| Placebo | Placebo Comparator | one capsule a day for 30 days will be given followed by a washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protandim | Dietary Supplement | The product Protandim used in this study have ingredients derived from five botanical sources [Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)]. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Decrease in Oxidative Stress markers. | the primary purpose of this trial is a preliminary study to examine the relationship to markers of oxidative stress,in response to Protandim, in Metabolic Syndrome. | every 30 days for 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Protein signatures | evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome | every 30 days for 120 days |
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Inclusion Criteria:
NCEP/ATP III criteria
Central obesity as measured by waist circumference:
Fasting blood triglycerides greater than or equal to 150 mg/dL
Blood HDL cholesterol:
Blood pressure greater than or equal to 130/85 mmHg or on anti-hypertensive Rx
Fasting glucose greater than or equal to 100 but < 125 mg/dL
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert H Eckel, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C509374 | Protandim |
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| D009750 |
| Nutritional and Metabolic Diseases |