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NCT Number: NCT04383951

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

NASH - Nonalcoholic Steatohepatitis Cirrhosis, Liver Digestive System Diseases Fatty Liver Fibrosis Liver Cirrhosis Liver Diseases Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

About this study

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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Pacemaker or implantable cardioverter devices
  • History of hepatic surgery
  • 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

Treatment and study plan

Dietary consult for participants in the ketogenic diet arm

Other

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 arm

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. MRI with proton density fat fraction (PDFF)

    Time frame: Performed at initial visit and at week 16 visit

    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.

  2. Weight loss and change in body composition

    Time frame: Performed at initial visit and at week 16 visit

    Changes in weight and body composition will be measured via serial use of a scale and use of bioelectrical impedance via an Inbody machine

  3. Changes in liver stiffness and steatosis

    Time frame: Performed at initial visit and at week 16 visit

    Changes in liver stiffness and steatosis will be measured with serial use of vibration controlled transient elastography (VCTE) via a FibroScan.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
May 12, 2020
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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