Ketogenic Diet for NASH Cirrhosis Weight Loss

Recruiting in Palo Alto (17 mi)

Overseen byRaj Vuppalanchi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Raj Vuppalanchi, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for obese individuals with a BMI over 30 who have NASH cirrhosis but no other major health issues like uncontrolled diabetes, significant alcohol consumption, or heart failure. It's not for those on weight loss drugs, in another fatty liver disease study, or with devices like pacemakers.

Inclusion Criteria

I am 18 years old or older.

I have NASH cirrhosis and my BMI is over 30.

Exclusion Criteria

Having a pacemaker or implantable cardioverter devices

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or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study

MELD score >12

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Treatment Details

Interventions

Ketogenic Diet (Behavioural Intervention)

Trial OverviewThe study compares the effects of a ketogenic diet (SKD) to standard dietary care (SOC) over 16 weeks in promoting weight loss among participants. Those in the SOC group will get a Weight Watchers voucher after completing the study.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Ketogenic dietActive Control1 Intervention

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.

Group II: Standard of CarePlacebo Group1 Intervention

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.