Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-04-30
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Protandim
one capsule a day for 30 days of protandim given, followed by a wash out period.
Protandim
The product Protandim used in this study have ingredients derived from five botanical sources \[Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)\].
Placebo
one capsule a day for 30 days will be given followed by a washout period.
Protandim
The product Protandim used in this study have ingredients derived from five botanical sources \[Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)\].
Interventions
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Protandim
The product Protandim used in this study have ingredients derived from five botanical sources \[Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)\].
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
60 Years
ALL
Yes
Sponsors
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LifeVantage
UNKNOWN
SomaLogic, Inc.
INDUSTRY
Responsible Party
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Univeristy of Colorado Denver
Principal Investigators
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Robert H Eckel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Denver
Aurora, Colorado, United States
Countries
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Other Identifiers
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SomaL-028 (withdrawn)
Identifier Type: -
Identifier Source: org_study_id