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The Effect of Protandim on Non-alcoholic Steatohepatitis

NCT00977730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-02-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of Protandim on the degree of liver injury after one year of supplementation. Protandim is a nutritional supplement composed of the following 5 botanical extracts: Bacopa Moniera extract, Milk Thistle extract, Ashwagandha powder, Green tea, and Turmeric extract. Protandim is commercially available and can be purchased without a prescription. Our findings could lead to a better understanding of the role of oxidative stress and antioxidant therapy in NASH and may ultimately help improve patient care.

Hypothesis #1: Protandim will lead to a significant improvement in NAS compared to placebo.

Hypothesis #2: Protandim will lead to a significant decrease in serum markers of oxidative stress and liver chemistry tests.

Hypothesis #3: Protandim will lead to decreased levels of TNF- α compared to placebo.

Conditions

  • Non-Alcoholic Steatohepatitis

Interventions

DIETARY_SUPPLEMENT

Protandim

1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day

DIETARY_SUPPLEMENT

Placebo

1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Gregory Austin, MD, MPH · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977730 on ClinicalTrials.gov