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Can a keto diet help obese patients with advanced liver disease?

NCT ID NCT04383951

Disease control Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a monitored ketogenic diet is safe and effective for weight loss in 40 obese adults with compensated NASH cirrhosis. Participants are randomly assigned to either a ketogenic diet or standard dietary advice for 16 weeks. The main goals are to check for liver complications and see how well people tolerate the diet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketogenic diet
What this could lead to
If successful, this could show that a ketogenic diet is a safe way for people with NASH cirrhosis to lose weight and potentially improve liver health.
What could go wrong
This is a small, early-stage study with only 40 people. The diet may be hard to follow, and results may not apply to everyone. There is also a risk of liver complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. NASH cirrhosis (criteria in Appendix 1) with obesity (BMI \>30 kg/m2). 2. Age 18 and greater Exclusion Criteria: 1. Actively participation in investigational drug treatment for non-alcoholic fatty liver disease 2. Currently taking medications for weight loss or have joined a supervised weight loss program prior to enrollment 3. Have hepatocellular carcinoma and are undergoing therapy 4. 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 5. Pacemaker or implantable cardioverter devices 6. History of hepatic surgery 7. Current significant alcohol consumption, defined as more than 20 grams per day in females or 30 grams per day in males 8. Presence of ascites or hepatic encephalopathy 9. Symptomatic gastroparesis 10. Uncontrolled diabetes, as defined by a HgbA1C \>11% 11. Uncontrolled congestive heart failure 12. Active infections 13. Child Turcotte Pugh score \> 6 14. MELD score \>12 15. Unwilling to undergo an MRI or have contraindications to an MRI

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis, liver NASH - nonalcoholic steatohepatitis

Contacts and locations

Locations

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

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