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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Metabolic Syndrome
 Dietary Supplement: Protandim

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 28
Study Start Date: April 2010
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)].

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125501

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
SomaLogic, Inc.
LifeVantage
Investigators
Principal Investigator: Robert H Eckel, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: Robert H. Eckel, MD; Professor of Medicine, Univeristy of Colorado Denver
ClinicalTrials.gov Identifier: NCT01125501     History of Changes
Other Study ID Numbers: SomaL-028 (withdrawn)
Study First Received: May 17, 2010
Last Updated: July 7, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013