Protandim and the Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Protandim and the Metabolic Syndrome: A Preliminary Study to Define Protein Signatures That Change Along With Lowered Oxidative Stress Measured as F2 Isoprostanes or TBARS and Inflammation Measured as hsCRP

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Protandim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age = 40-60 years of age Meets at least 3 of the 5 criteria for the metabolic syndrome (as defined by NCEP/ATP III criteria) NCEP/ATP III criteria Central obesity as measured by waist circumference: Men - Greater than 40 inches Women - Greater than 35 inches Fasting blood triglycerides greater than or equal to 150 mg/dL Blood HDL cholesterol: Men - Less than 40 mg/dL Women - Less than 50 mg/dL 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: Women taking hormone replacement therapy for post menopause Signs or symptoms of acute coronary syndrome History of congestive heart failure (prior myocardial infarction, coronary artery disease including stent placement, coronary artery bypass graft, EBCT calcium score of at least 100, or a positive stress test) Serum creatinine > 1.5 mg/dL, AST or ALT > 2 times ULN, HgA1c >6.5%, severely depressed or elevated blood cell lines, triglycerides > 500, TSH outside of normal range, elevated calcium, blood pressure > 160/100, urine protein > 30 ,g/dl. Concurrent medical conditions/illnesses in which expected life expectancy is 2 years or less and/or are likely to require frequent hospitalizations and treatment adjustments (e.g., cirrhosis, active malignancy, , or highly active rheumatologic condition, lupus, rheumatoid arthritis or chronic obstructive pulmonary disease and diabetes). Participation in any other investigational substance or medical device study within 30 days before this trial and/or participation in such entity during this trial. Known pregnancy. Supplementation with nutraceuticals or if so one month washout before initiating the study before initiating this trial. Taking statins or fibrates to lower cholesterol Inability or unwillingness to provide written informed consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Protandim<br>one capsule a day for 30 days of protandim given, followed by a wash out period. | Dietary Supplement: Protandim<br>* 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)].<br>|
| Placebo Comparator: Placebo<br>one capsule a day for 30 days will be given followed by a washout period. | Dietary Supplement: Protandim<br>* 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)].<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |