🏛️ Verified NIH Record • Updated 2026-04-14
Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis (NCT04383951)
🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Indiana University
🩺 Plain-English Summary (8th-Grade Level)
This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.
Who can join: Review the eligibility criteria below.
Location: Indiana University School of Medicine — Indianapolis, Indiana
Age range: 18 Years
🧪 Interventions in This Study
- Dietary consult for participants in the ketogenic diet arm (OTHER)
- Dietary consult for participants in the standard of care arm (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Indiana University School of Medicine — Indianapolis, Indiana
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in NASH - Nonalcoholic Steatohepatitis
- Statins for the Treatment of NASH — Rochester, Minnesota
- A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) — Birmingham, Alabama
- Estrogen Administration for the Treatment of NASH in Postmenopausal Women — Boston, Massachusetts
- A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis — Birmingham, Alabama
- Novel MRE Technique to Assess a Risk Factor for Liver Cancer — Stanford, California
- Hepatic Energy Fluxes in NASH and NAS Patients — Minneapolis, Minnesota
Explore by condition: All NASH - Nonalcoholic Steatohepatitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.