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.
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 have NASH cirrhosis and my BMI is over 30.
Exclusion Criteria
I am currently being treated for liver cancer.
I do not have any active infections.
My liver function is moderately to severely impaired.
I have symptoms of delayed stomach emptying.
I have had liver surgery in the past.
I drink less than 20g (females) or 30g (males) of alcohol daily.
I am currently on medication for weight loss or in a weight loss program.
I have heart failure that is not well-managed.
I have fluid in my abdomen or have experienced confusion due to liver problems.
Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Indiana University School of MedicineIndianapolis, IN
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Who is running the clinical trial?
Indiana UniversityLead Sponsor