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.

Study Overview

• Status: Withdrawn
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Protandim

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Protandim; one capsule a day for 30 days of protandim given, followed by a wash out period.	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)].
Placebo Comparator: Placebo; one capsule a day for 30 days will be given followed by a washout period.	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)].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure Decrease in Oxidative Stress markers.	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.	every 30 days for 120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein signatures	evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome	every 30 days for 120 days

Collaborators and Investigators

• Sponsor: SomaLogic, Inc.
• Collaborators: LifeVantage
• Investigators: Principal Investigator: Robert H Eckel, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: SomaL-028 (withdrawn)