Protandim and the Metabolic Syndrome

Not Applicable

Withdrawn

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Protandim

• Registration Number: NCT01125501
• Lead Sponsor: SomaLogic, Inc.

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Protandim	Protandim	one capsule a day for 30 days of protandim given, followed by a wash out period.
Placebo	Protandim	one capsule a day for 30 days will be given followed by a washout period.

Primary Outcome Measures

Name	Time	Method
Measure Decrease in Oxidative Stress markers.	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.

Secondary Outcome Measures

Name	Time	Method
Protein signatures	every 30 days for 120 days	evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States