Active — Not RecruitingNot Applicable

Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis

United States40 participantsStarted 2020-08-15

Plain-language summary

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 participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. NASH cirrhosis (criteria in Appendix 1) with obesity (BMI \>30 kg/m2).
. Age 18 and greater

Exclusion criteria

. 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or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood chemistry to assess for liver de-compensation events

Timeframe: Blood chemistry tests will be assessed at the initial visit.

Blood chemistry to assess for liver de-compensation events

Timeframe: Blood chemistry tests will be assessed at the study visits between weeks 5 and 14.

Blood chemistry to assess for liver de-compensation events

Timeframe: Blood chemistry tests will be assessed at the Week 16 visit.

Adverse events

Timeframe: All participants will be monitored at the study visits between weeks 5 and 14 and all participants will be instructed to alert the study team for additional information if such an event occurs.

Adverse events

Timeframe: All participants will be monitored at the week 16 visit and all participants will be instructed to alert the study team for additional information if such an event occurs.

Tolerability of the ketogenic diet

Timeframe: The POMS 40 questionnaire is administered at the initial visit.

Trial details

NCT IDNCT04383951

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More NASH - Nonalcoholic Steatohepatitis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. NASH cirrhosis (criteria in Appendix 1) with obesity (BMI \>30 kg/m2).
. Age 18 and greater

Exclusion criteria

. 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

What they're measuring

Blood chemistry to assess for liver de-compensation events

Timeframe: Blood chemistry tests will be assessed at the initial visit.

Blood chemistry to assess for liver de-compensation events

Timeframe: Blood chemistry tests will be assessed at the study visits between weeks 5 and 14.

Blood chemistry to assess for liver de-compensation events

Timeframe: Blood chemistry tests will be assessed at the Week 16 visit.

Adverse events

Timeframe: All participants will be monitored at the week 16 visit and all participants will be instructed to alert the study team for additional information if such an event occurs.

Tolerability of the ketogenic diet

Timeframe: The POMS 40 questionnaire is administered at the initial visit.