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Protandim and the Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protandim
Sponsored by
SomaLogic, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Protandim

Placebo

Arm Description

one capsule a day for 30 days of protandim given, followed by a wash out period.

one capsule a day for 30 days will be given followed by a washout period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Protein signatures
evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome

Full Information

First Posted
May 17, 2010
Last Updated
October 16, 2017
Sponsor
SomaLogic, Inc.
Collaborators
LifeVantage
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1. Study Identification

Unique Protocol Identification Number
NCT01125501
Brief Title
Protandim and the Metabolic Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Withdrawn
Why Stopped
funding not available
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
SomaLogic, Inc.
Collaborators
LifeVantage

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protandim
Arm Type
Active Comparator
Arm Description
one capsule a day for 30 days of protandim given, followed by a wash out period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one capsule a day for 30 days will be given followed by a washout period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protandim
Intervention Description
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)].
Primary Outcome Measure Information:
Title
Measure Decrease in Oxidative Stress markers.
Description
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.
Time Frame
every 30 days for 120 days
Secondary Outcome Measure Information:
Title
Protein signatures
Description
evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome
Time Frame
every 30 days for 120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Eckel, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Protandim and the Metabolic Syndrome

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