NCT04383951Active, not recruiting
Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 17 Apr 2020
- Start date
- 15 Aug 2020
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Indiana University
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04383951
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 15 Aug 2020 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Actively participation in investigational drug treatment for non-alcoholic fatty liver disease
- Currently taking medications for weight loss or have joined a supervised weight loss program prior to enrollment
- Have hepatocellular carcinoma and are undergoing therapy
- Women who become pregnant or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study
Other illness
- History of hepatic surgery
- Uncontrolled diabetes, as defined by a HgbA1C \>11%
- Uncontrolled congestive heart failure
- Active infections
Other
- Pacemaker or implantable cardioverter devices
- Current significant alcohol consumption, defined as more than 20 grams per day in females or 30 grams per day in males
- Presence of ascites or hepatic encephalopathy
- Symptomatic gastroparesis
- Child Turcotte Pugh score \> 6
- MELD score \>12
- Unwilling to undergo an MRI or have contraindications to an MRI
Who the study is looking for
- NASH cirrhosis (criteria in Appendix 1) with obesity (BMI \>30 kg/m2).
- Age 18 and greater
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.