NASH - Nonalcoholic SteatohepatitisNCT04383951
Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
A study testing Dietary consult for participants in the ketogenic diet arm in people with NASH - Nonalcoholic Steatohepatitis and Cirrhosis, Liver, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- What is being tested?
- Dietary consult for participants in the ketogenic diet arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NASH cirrhosis (criteria in Appendix 1) with obesity (BMI >30 kg/m2).
- Age 18 and greater
Who cannot join
- 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or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study
- Pacemaker or implantable cardioverter devices
- History of hepatic surgery
Show all 15Show fewer
- 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
- Uncontrolled diabetes, as defined by a HgbA1C >11%
- Uncontrolled congestive heart failure
- Active infections
- Child Turcotte Pugh score > 6
- MELD score >12
- Unwilling to undergo an MRI or have contraindications to an MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
The primary aim is to assess the safety of ketogenic diet as compared to standard of care approach for weight loss in patients with compensated cirrhosis due to NASH. The safety endpoints captured in the study include liver decompensation events, measured through several questionnaires, fasting blood glucose, serum creatinine, fasting lipid profile and other adverse events. The tolerability of the ketogenic diet will be assessed by study compliance and by administering a questionnaire.
Secondary aims include weight loss, changes in body composition via serial use of bioelectrical impedance via an Inbody Machine, changes in liver fat and liver stiffness using MRI and proton density fat fraction (MRI-PDFF), liver biochemistries, changes in Child-Turcotte-Pugh and MELD scores measured via labs and changes in liver steatosis and stiffness via serial measures of VCTE by FibroScan®.
- Being tested
- Dietary consult for participants in the ketogenic diet arm, Dietary consult for participants in the standard of care arm
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary consult for participants in the ketogenic diet armOther
An initial consultation with the providers of medically supervised weight loss clinic will be arranged. Participants in the ketogenic diet group will be educated on the concepts of the diet and will be provided with recipes to be utilized at home that adhere to this diet. In addition to the initial consultation, participants in this arm receive additional consultations with these providers with a frequency as determined by the provider.
Dietary consult for participants in the standard of care armOther
For participants in the standard of care arm, an initial consultation with the providers of medically supervised weight loss clinic will be arranged and the discussion will center around portion control using a balanced diet. Participants will receive only one additional consultation with the provider 16 weeks later just prior to the conclusion of the study.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Active comparator | For participants randomized to the ketogenic diet arm, a consultation with the providers of medically supervised weight loss clinic of Indiana University Health will be arranged. Subjects will be educated on the concepts of ketosis, symptoms associated with it, and dietary manipulation to achieve ketosis. Participants in this arm will use the suggested recipes in combination with strict carbohydrate monitoring though checking for urine ketone bodies. These recipes were gathered and vetted by the dietitian at the medically supervised weight loss clinic. We anticipate that this approach will allow for more calorie intake and easier carbohydrate restriction. The follow up visits will be determined by the providers of the medically supervised weight loss clinic based on the symptoms reported and subject's compliance with carbohydrate restriction. Receives: Other: Dietary consult for participants in the ketogenic diet arm |
| Standard of Care | Sham comparator | For participants randomized to this arm, a consultation with the providers of medically supervised weight loss clinic will be arranged. The discussion will focus on portion control using a balanced diet. A follow up visit will be at 16 weeks. This is the extent of interventions received for participants in this arm. Receives: Other: Dietary consult for participants in the standard of care arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood chemistry to assess for liver de-compensation events
Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.
Measured: Blood chemistry tests will be assessed at the initial visit.
Blood chemistry to assess for liver de-compensation events
Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.
Measured: Blood chemistry tests will be assessed at the study visits between weeks 5 and 14.
Blood chemistry to assess for liver de-compensation events
Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.
Measured: Blood chemistry tests will be assessed at the Week 16 visit.
Adverse events
All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.
Measured: 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
All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.
Measured: 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
How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.
Measured: The POMS 40 questionnaire is administered at the initial visit.
Tolerability of the ketogenic diet
How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.
Measured: The POMS 40 questionnaire is administered at the study visits between weeks 1 and 4.
Tolerability of the ketogenic diet
How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.
Measured: The POMS 40 questionnaire is administered at the Week 16 visit.
Secondary outcomes (3)
MRI with proton density fat fraction (PDFF)
MRI-PDFF is a convenient method for liver fat quantification and currently used in most clinical trials, as it only requires a single 20-second breath hold and an estimated time of about 5 minutes in an MRI scanner suite. MRI in the study will be used to quantify liver steatosis, stiffness, and body composition.
Measured: Performed at initial visit and at week 16 visit
Weight loss and change in body composition
Changes in weight and body composition will be measured via serial use of a scale and use of bioelectrical impedance via an Inbody machine
Measured: Performed at initial visit and at week 16 visit
Changes in liver stiffness and steatosis
Changes in liver stiffness and steatosis will be measured with serial use of vibration controlled transient elastography (VCTE) via a FibroScan.
Measured: Performed at initial visit and at week 16 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 Aug 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomization will be utilized to ensure balancing of treatment groups throughout enrollment. 30 participants will be assigned to the ketogenic diet arm and 10 will be assigned to standard of care.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Vuppalanchi, Indiana University
- Investigators
- Raj Vuppalanchi, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383951
- Sponsor's protocol ID
- Keto Diet Study
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2020
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD at this time
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
- ClinicalTrials.gov ID
- NCT04383951
- Acronym / sponsor ID
- Keto Diet Study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim is to assess the safety of ketogenic diet as compared to standard of care approach for weight loss in patients with compensated cirrhosis due to NASH. The safety endpoints captured in the study include liver decompensation events, measured through several questionnaires, fasting blood glucose, serum creatinine, fasting lipid profile and other adverse events. The tolerability of the ketogenic diet will be assessed by study compliance and by administering a questionnaire.
Secondary aims include weight loss, changes in body composition via serial use of bioelectrical impedance via an Inbody Machine, changes in liver fat and liver stiffness using MRI and proton density fat fraction (MRI-PDFF), liver biochemistries, changes in Child-Turcotte-Pugh and MELD scores measured via labs and changes in liver steatosis and stiffness via serial measures of VCTE by FibroScan®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Block randomization will be utilized to ensure balancing of treatment groups throughout enrollment. 30 participants will be assigned to the ketogenic diet arm and 10 will be assigned to standard of care.
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Active comparator | Other: Dietary consult for participants in the ketogenic diet armFor participants randomized to the ketogenic diet arm, a consultation with the providers of medically supervised weight loss clinic of Indiana University Health will be arranged. Subjects will be educated on the concepts of ketosis, symptoms associated with it, and dietary manipulation to achieve ketosis. Participants in this arm will use the suggested recipes in combination with strict carbohydrate monitoring though checking for urine ketone bodies. These recipes were gathered and vetted by the dietitian at the medically supervised weight loss clinic. We anticipate that this approach will allow for more calorie intake and easier carbohydrate restriction. The follow up visits will be determined by the providers of the medically supervised weight loss clinic based on the symptoms reported and subject's compliance with carbohydrate restriction. |
| Standard of Care | Sham comparator | Other: Dietary consult for participants in the standard of care armFor participants randomized to this arm, a consultation with the providers of medically supervised weight loss clinic will be arranged. The discussion will focus on portion control using a balanced diet. A follow up visit will be at 16 weeks. This is the extent of interventions received for participants in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- NASH cirrhosis (criteria in Appendix 1) with obesity (BMI >30 kg/m2).
- Age 18 and greater
Key exclusion criteria (15 listed)
- 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
- Pacemaker or implantable cardioverter devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary consult for participants in the ketogenic diet armAn initial consultation with the providers of medically supervised weight loss clinic will be arranged. Participants in the ketogenic diet group will be educated on the concepts of the diet and will be provided with recipes to be utilized at home that adhere to this diet. In addition to the initial consultation, participants in this arm receive additional consultations with these providers with a frequency as determined by the provider. | Other | Ketogenic diet |
| Dietary consult for participants in the standard of care armFor participants in the standard of care arm, an initial consultation with the providers of medically supervised weight loss clinic will be arranged and the discussion will center around portion control using a balanced diet. Participants will receive only one additional consultation with the provider 16 weeks later just prior to the conclusion of the study. | Other | Standard of Care |
Primary outcome
Blood chemistry to assess for liver de-compensation events
Time frame: Blood chemistry tests will be assessed at the initial visit.
Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.
Blood chemistry to assess for liver de-compensation events
Time frame: Blood chemistry tests will be assessed at the study visits between weeks 5 and 14.
Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.
Blood chemistry to assess for liver de-compensation events
Time frame: Blood chemistry tests will be assessed at the Week 16 visit.
Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.
Adverse events
Time frame: 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.
All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.
Adverse events
Time frame: 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.
All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.
Tolerability of the ketogenic diet
Time frame: The POMS 40 questionnaire is administered at the initial visit.
How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.
Tolerability of the ketogenic diet
Time frame: The POMS 40 questionnaire is administered at the study visits between weeks 1 and 4.
How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.
Tolerability of the ketogenic diet
Time frame: The POMS 40 questionnaire is administered at the Week 16 visit.
How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.
3 secondary outcomes
MRI with proton density fat fraction (PDFF)
Time frame: Performed at initial visit and at week 16 visit
Weight loss and change in body composition
Time frame: Performed at initial visit and at week 16 visit
Changes in liver stiffness and steatosis
Time frame: Performed at initial visit and at week 16 visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. No IPD at this time
Related trials for NASH - Nonalcoholic Steatohepatitis
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
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 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Vuppalanchi, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary consult for participants in the ketogenic diet arm in people with NASH - Nonalcoholic Steatohepatitis and Cirrhosis, Liver, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood chemistry to assess for liver de-compensation events (time frame: Blood chemistry tests will be assessed at the initial visit.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.