The Effect of Protandim on Non-alcoholic Steatohepatitis

NCT00977730 | Completed DMC

• 1 other identifier: 07-0848
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hepatitis; Fatty Liver; Non Alcoholic Steatohepatitis; Protandim

Outcome Measures

Primary Outcomes (1)

• Change in NAS at study completion in the Protandim group compared to the placebo group.

  12 months

Study Arms (2)

Protandim

ACTIVE COMPARATOR

Dietary Supplement: Protandim

Sugar pill

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Protandim DIETARY_SUPPLEMENT

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

Protandim

Placebo DIETARY_SUPPLEMENT

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

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at entry at least 18 years.
• Serum alanine (ALT) aminotransferase activity that is above the upper limits of normal.
• Evidence of steatohepatitis on liver biopsy performed within the previous 6 months with a NAFLD activity score (NAS) of at least 3 (of a total possible score of 8) including a score of at least 1 each for steatosis, hepatocellular injury and parenchymal inflammation. Histological criteria of steatohepatitis include: (1) macrovesicular steatosis, (2) acinar zone 3 hepatocellular injury (ballooning degeneration), (3) parenchymal inflammation, and (4) portal inflammation. Additional (but not required) features include the presence of (5) Mallory's hyaline and (6) pericellular and/or sinusoidal fibrosis that predominantly involves zone 3.
• Written informed consent.
• Willingness to have a repeat percutaneous liver biopsy following 1 year of supplementation.

You may not qualify if:

• Evidence of another form of liver disease as evidenced by any of the following:
• Hepatitis B, as defined by the presence of hepatitis B surface antigen (HBsAg).
• Hepatitis C, as defined by the presence of hepatitis C virus (HCV) antibody or HCV RNA in serum.
• Autoimmune hepatitis, as defined by anti-nuclear antibody (ANA) of 1:160 or greater (or positive smooth muscle antibody) and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
• Autoimmune cholestatic liver disorders, as defined by elevation of anti-mitochondrial antibody of greater than 1:80 (or positive AMA by lab report if a titer is not given) or liver histology consistent with primary biliary cirrhosis or primary (or secondary) sclerosing cholangitis.
• Wilson's disease, as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson's disease.
• Alpha-1-antitrypsin deficiency, as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
• Iron overload/hemochromatosis, as defined by the following: elevated transferrin saturation (greater than 45 percent) OR serum ferritin (\> 300 microg/L in men or \>200 microg/L in women), with one of the following: 1) presence of 3+ or 4+ stainable iron on liver biopsy (if obtained); or 2) Hemochromatosis gene testing showing homozygosity for C282Y or compound heterozygosity for C282Y/H63D (if obtained).
• Drug-induced liver disease, as defined on the basis of typical exposure and history.
• Intrahepatic and/or extrahepatic duct obstruction, as shown by imaging studies (if obtained).
• History of excess alcohol ingestion, averaging more than 40 gm/day (3 drinks per day) at any time in the previous 10 years, or history of alcohol intake averaging greater than 40 gm/week (3 drinks/week) in the previous year.
• Contraindications to liver biopsy: platelet counts less than 75,000/mm(3) or INR\>1.4.
• Stage III or IV fibrosis on baseline liver biopsy.
• History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including (but not limited to) corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months.
• Presence of diabetes mellitus as defined by any of the following: 1) fasting plasma glucose of greater than or equal to 126 mg/dl on 2 separate occasions; or 2) diabetic symptoms with a history of random plasma glucose of greater than or equal to 200 mg/dl.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado at Denver and Health Sciences Center

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hepatitis; Fatty Liver

Interventions

Protandim

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Gregory Austin, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 16, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 5, 2013

Record last verified: 2009-09

Locations

US (1)