NCT00977730 (NASH) is a NA clinical trial of Protandim in Non-Alcoholic Steatohepatitis, sponsored by University of Colorado, Denver.

Who is sponsoring NCT00977730?

NCT00977730 is sponsored by University of Colorado, Denver.

What drugs are being tested in NCT00977730?

Interventions in NCT00977730: Protandim, Placebo.

What condition does NCT00977730 study?

NCT00977730 studies Non-Alcoholic Steatohepatitis.

Is NCT00977730 still recruiting?

NCT00977730 is currently completed. Last updated 1 February 2013.

Last reviewed 2013-02-01 · How we verify

NCT00977730: NASH

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 1 February 2013

What this trial tests

NA trial testing Protandim in Non-Alcoholic Steatohepatitis in 70 participants. Completed in 1 July 2011.

Timeline

1 July 2008

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	70
Start date	1 July 2008
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	1 location across United States

Drugs / interventions tested

Protandim — full drug profile →
Placebo

Conditions studied

Non-Alcoholic Steatohepatitis — all drugs for Non-Alcoholic Steatohepatitis →

Sponsor

University of Colorado, Denver

Who can join

18 and older, any sex, with Non-Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in NAS at study completion in the Protandim group compared to the placebo group.
Time frame: 12 months

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Herbal drug discovery for the treatment of nonalcoholic fatty liver disease.
Yan T, Yan N, Wang P, Xia Y, et al · · 2020 · cited 162× · PMID 31993304 · DOI 10.1016/j.apsb.2019.11.017
Nutritional supplementation for nonalcohol-related fatty liver disease: a network meta-analysis.
Komolafe O, Buzzetti E, Linden A, Best LM, et al · · 2021 · cited 12× · PMID 34280304 · DOI 10.1002/14651858.cd013157.pub2
Addressing the heterogeneity in liver diseases using biological networks.
Lam S, Doran S, Yuksel HH, Altay O, et al · · 2021 · cited 5× · PMID 32201876 · DOI 10.1093/bib/bbaa002

Verify or expand the search:

Other trials of Protandim

Trials testing the same drug.

NCT06429059 — ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) · Phase 2 · completed

Other recruiting trials for Non-Alcoholic Steatohepatitis

Currently open trials in the same condition.

NCT05065593 — The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis · NA · active not recruiting
NCT04690972 — "Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chron · recruiting
NCT03884075 — Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES) · Phase 2 · recruiting

Other University of Colorado, Denver trials

Trials by the same sponsor.

NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00977730 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 1 February 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00977730.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing