Protandim and the Metabolic Syndrome
| Status: | Withdrawn |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 40 - 60 |
| Updated: | 10/20/2017 |
| Start Date: | April 2010 |
| End Date: | June 2010 |
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
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.
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.
oxidation in subjects (40-60 years of age) with the Metabolic Syndrome.
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
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