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| Sponsor: | University of Colorado, Denver |
|---|---|
| Information provided by: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00977730 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Non-Alcoholic Steatohepatitis |
Dietary Supplement: Protandim Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of the Dietary Supplement Protandim on Non-Alcoholic Steatohepatitis: A Randomized, Double Blind, Placebo-Controlled Study |
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Protandim |
Dietary Supplement: Protandim
1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day
|
| Placebo Comparator: Sugar pill |
Dietary Supplement: Placebo
1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Evidence of another form of liver disease as evidenced by any of the following:
Contacts and Locations| United States, Colorado | |
| University of Colorado at Denver and Health Sciences Center | |
| Denver, Colorado, United States, 80045 | |
| Principal Investigator: | Gregory Austin, MD, MPH | University of Colorado, Denver |
More Information
| Responsible Party: | Dr. Gregory Austin MD, MPH; Assistant Professor of Medicine, University of Colorado at Denver and Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00977730 History of Changes |
| Other Study ID Numbers: | 07-0848 |
| Study First Received: | September 14, 2009 |
| Last Updated: | September 15, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Hepatitis Fatty Liver Non Alcoholic Steatohepatitis Protandim |
|
Fatty Liver Liver Diseases Digestive System Diseases |