Clinical trial NCT01125501: Protandim and the Metabolic Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: LifeVantage
First posted: 2010-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure Decrease in Oxidative Stress markers.
timeFrame: every 30 days for 120 days
Secondary outcomes:
measure: Protein signatures
timeFrame: every 30 days for 120 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Robert H Eckel, MD
role: PRINCIPAL_INVESTIGATOR
References: