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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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014