Protandim and the Metabolic Syndrome

• ClinicalTrials.gov Identifier: NCT01125501
• Recruitment Status: Withdrawn
• First Posted: May 18, 2010
• Last Update Posted: October 18, 2017
• Sponsor: SomaLogic, Inc.
• Collaborator: LifeVantage
• Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information

• First Submitted Date: May 17, 2010
• First Posted Date: May 18, 2010
• Last Update Posted Date: October 18, 2017
• Study Start Date: April 2010
• Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Metabolic Syndrome

Intervention

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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 16, 2017): 0
• Original Estimated Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01125501
• Other Study ID Numbers: 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: SomaLogic, Inc.
• Collaborators: LifeVantage

Investigators

• 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