Protandim and the Metabolic Syndrome

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01125501
• Other study ID #: SomaL-028 (withdrawn)
• Status: Withdrawn
• Phase: N/A
• First received: May 17, 2010
• Last updated: October 16, 2017
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• 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)].

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
SomaLogic, Inc.	LifeVantage

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Protein signatures	evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome	every 30 days for 120 days