Protandim and the Metabolic Syndrome

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT01125501

Run by

SomaLogic, Inc.

People needed

0

Starts

2010-04-01

Expected to finish

2010-06-01

Last updated by the study team

2017-10-18

Who can join

Age: 40 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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