NCT01125501

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 18, 2017

Status Verified

July 1, 2010

Enrollment Period

2 months

First QC Date

May 17, 2010

Last Update Submit

October 16, 2017

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Protein signatures

    every 30 days for 120 days

Study Arms (2)

Protandim

ACTIVE COMPARATOR

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

Dietary Supplement: Protandim

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Protandim

Interventions

ProtandimDIETARY_SUPPLEMENT

The product Protandim used in this study have ingredients derived from five botanical sources \[Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)\].

PlaceboProtandim

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Protandim

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robert H Eckel, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 18, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 18, 2017

Record last verified: 2010-07

Locations

US(1)