Non-Alcoholic SteatohepatitisNASHNCT00977730
The Effect of Protandim on Non-alcoholic Steatohepatitis
A study testing Protandim in people with Non-Alcoholic Steatohepatitis, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Steatohepatitis
- What is being tested?
- Protandim
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Use of anti-diabetic drugs, including insulin, biguanides, sulfonylureas, weight loss medications (either over the counter or prescription), or thiazolidinediones in the previous 6 months. Use of these medications will also be prohibited for the duration of the study.
- Use of cholesterol lowering medications, including statins.
- Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease with hypoxia, renal failure, organ transplantation, serious psychiatric disease, HIV, or malignancy that, in the opinion of the investigator would preclude adequate follow up.
- Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
- Pregnancy.
- Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study that is suggestive of liver cancer.
- Serum creatinine greater than 1.5 mg/dl in men and greater than 1.3 mg/dl in women.
- Body habitus or other patient issues that necessitated the original liver biopsy being obtained through radiology (by transjugular approach).
- Abnormal thyroid function, as indicated by an abnormal screening TSH.
- Total Bilirubin > 2.0
- AST or ALT > 3 times the upper limits of normal.
- Serum Sodium <130
- Hematocrit < 35
- Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.
- Use of any herbal or non-prescription medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, 80045
About this study
Official title: The Effect of the Dietary Supplement Protandim on Non-Alcoholic Steatohepatitis: A Randomized, Double Blind, Placebo-Controlled Study
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.
Read more
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
- Being tested
- Protandim, Placebo
- Keywords
- Hepatitis, Fatty Liver, Non Alcoholic Steatohepatitis, Protandim
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hepatitis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtandimDietary supplement
1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day
PlaceboDietary supplement
1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day
| Study group | Role | What they receive |
|---|---|---|
| Protandim | Active comparator | Not described Receives: Dietary Supplement: Protandim |
| Sugar pill | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NAS at study completion in the Protandim group compared to the placebo group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Austin, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977730
- Sponsor's protocol ID
- 07-0848
- Acronym
- NASH
- Status last verified
- Sep 2009
- First submitted
- 14 Sep 2009
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Dietary Supplement Protandim on Non-Alcoholic Steatohepatitis: A Randomized, Double Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00977730
- Acronym / sponsor ID
- NASH / 07-0848
- Conditions
- Non-Alcoholic Steatohepatitis
- Keywords
- Hepatitis, Fatty Liver, Non Alcoholic Steatohepatitis, Protandim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protandim | Active comparator | Dietary Supplement: Protandim |
| Sugar pill | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (30 listed)
- Evidence of another form of liver disease as evidenced by any of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protandim1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day | Dietary supplement | Protandim |
| Placebo1 675 mg capsule Protandim PO/day vs. 1 sugar pill PO/day | Dietary supplement | Sugar pill |
Primary outcome
Change in NAS at study completion in the Protandim group compared to the placebo group.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Austin, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protandim in people with Non-Alcoholic Steatohepatitis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NAS at study completion in the Protandim group compared to the placebo group. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.