Metabolic Syndrome
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTProtandim
The product Protandim used in this study have ingredients derived from five botanical sources \[Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)\].
Sponsors
LifeVantage
SomaLogic, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Decrease in Oxidative Stress markers. | every 30 days for 120 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protein signatures | every 30 days for 120 days | evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome |
Countries
United States
Outcome results
None listed