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

NCT04383951 | Active Not Recruiting DMC

• 1 other identifier: Keto Diet Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NASH - Nonalcoholic Steatohepatitis; Cirrhosis, Liver

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  The POMS 40 questionnaire is administered at the Week 16 visit.

Secondary Outcomes (3)

• MRI with proton density fat fraction (PDFF)

  Performed at initial visit and at week 16 visit

• Weight loss and change in body composition

  Performed at initial visit and at week 16 visit

• Changes in liver stiffness and steatosis

  Performed at initial visit and at week 16 visit

Study Arms (2)

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.

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.

Other: Dietary consult for participants in the standard of care arm

Interventions

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.

Ketogenic diet

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raj Vuppalanchi, M.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: While this is an open label study, the principal investigator will be blinded to the results of efficacy outcomes such as MRI-PDFF, Body composition data, VCTE by FibroScan® and study questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: May 12, 2020
• Study Start: August 15, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)