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Protandim and the Metabolic Syndrome

This study has been withdrawn prior to enrollment.
(funding not available)
Sponsor:
Collaborator:
LifeVantage
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01125501
First received: May 17, 2010
Last updated: July 7, 2010
Last verified: July 2010
History of Changes

May 17, 2010
July 7, 2010
April 2010
June 2010   (final data collection date for primary outcome measure)
Measure Decrease in Oxidative Stress markers. [ Time Frame: every 30 days for 120 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01125501 on ClinicalTrials.gov Archive Site
Protein signatures [ Time Frame: every 30 days for 120 days ] [ Designated as safety issue: No ]
evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome
Same as current
Not Provided
Not Provided
 
Protandim and the Metabolic Syndrome
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Metabolic Syndrome
Dietary Supplement: 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)].
  • Active Comparator: Protandim
    one capsule a day for 30 days of protandim given, followed by a wash out period.
    Intervention: Dietary Supplement: Protandim
  • Placebo Comparator: Placebo
    one capsule a day for 30 days will be given followed by a washout period.
    Intervention: Dietary Supplement: Protandim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
28
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01125501
SomaL-028 (withdrawn)
No
Not Provided
Not Provided
Robert H. Eckel, MD; Professor of Medicine, Univeristy of Colorado Denver
SomaLogic, Inc.
LifeVantage
Principal Investigator: Robert H Eckel, MD University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP