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Behavioural Intervention

Ketogenic Diet for NASH Cirrhosis Weight Loss

N/A

Waitlist Available

Led By Raj Vuppalanchi, M.D.

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NASH cirrhosis with obesity (BMI >30 kg/m2)

Be older than 18 years old

Must not have

Having hepatocellular carcinoma and undergoing therapy

Active infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the poms 40 questionnaire is administered at the week 16 visit.

Summary

This trial will compare a ketogenic diet to a standard diet, and will measure weight loss over 16 weeks.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects from following a ketogenic diet may include fatigue, headache, dizziness during initial adaptation ('keto flu'), nutrient deficiencies if not properly managed and potential exacerbation of existing liver conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have NASH cirrhosis and my BMI is over 30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for liver cancer.

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I do not have any active infections.

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My liver function is moderately to severely impaired.

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I have symptoms of delayed stomach emptying.

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I have had liver surgery in the past.

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I drink less than 20g (females) or 30g (males) of alcohol daily.

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I am currently on medication for weight loss or in a weight loss program.

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I have heart failure that is not well-managed.

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I have fluid in my abdomen or have experienced confusion due to liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the poms 40 questionnaire is administered at the week 16 visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the poms 40 questionnaire is administered at the week 16 visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the poms 40 questionnaire is administered at the week 16 visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Blood chemistry to assess for liver de-compensation events

Tolerability of the ketogenic diet

Secondary study objectives

Changes in liver stiffness and steatosis

MRI with proton density fat fraction (PDFF)

Weight loss and change in body composition

Trial Design

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.

0 / 10Eligibility criteria met