NCT00977730

The Effect of Protandim on Non-alcoholic Steatohepatitis

The Effect of the Dietary Supplement Protandim on Non-Alcoholic Steatohepatitis: A Randomized, Double Blind, Placebo-Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-09-16
• Last updated: 2013-02-05

Locations

1 site across 1 country: United States