Protandim and the Metabolic Syndrome

Tracking Information
First Submitted Date ICMJE	May 17, 2010
First Posted Date ICMJE	May 18, 2010
Last Update Posted Date	October 18, 2017
Study Start Date ICMJE	April 2010
Estimated Primary Completion Date	June 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 17, 2010)	Measure Decrease in Oxidative Stress markers. [ Time Frame: 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01125501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 17, 2010)	Protein signatures [ Time Frame: every 30 days for 120 days ]; evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Protandim and the Metabolic Syndrome
Official Title ICMJE	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
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
Condition ICMJE	Metabolic Syndrome
Intervention ICMJE	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)].
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Withdrawn
Actual Enrollment ICMJE; (submitted: October 16, 2017)	0
Original Estimated Enrollment ICMJE; (submitted: May 17, 2010)	28
Estimated Study Completion Date	June 2010
Estimated Primary Completion Date	June 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years to 60 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01125501
Other Study ID Numbers ICMJE	SomaL-028 (withdrawn)
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Robert H. Eckel, MD; Professor of Medicine, Univeristy of Colorado Denver
Study Sponsor ICMJE	SomaLogic, Inc.
Collaborators ICMJE	LifeVantage
Investigators ICMJE	Principal Investigator: Robert H Eckel, MD University of Colorado, Denver
PRS Account	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	July 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP