Ketogenic Diet for NASH Cirrhosis Weight Loss
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on weight loss medications or in a supervised weight loss program before joining.
What data supports the effectiveness of the ketogenic diet as a treatment for NASH cirrhosis weight loss?
Research shows that a ketogenic diet, which is high in fat and low in carbohydrates, can help reduce liver fat and improve liver health in people with nonalcoholic fatty liver disease (NAFLD), a condition related to NASH. Studies have found that this diet can lead to significant weight loss and improvements in liver function markers.12345
Is the ketogenic diet safe for humans?
How does the ketogenic diet treatment for NASH cirrhosis differ from other treatments?
The ketogenic diet is unique for NASH cirrhosis as it focuses on a high-fat, low-carbohydrate intake, which can lead to significant weight loss and reduction in liver fat, unlike other diets that may not achieve the necessary weight loss to improve NASH severity. This diet also potentially reduces liver inflammation and fibrosis, offering a novel approach compared to traditional low-fat diets.12349
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants follow a ketogenic diet or standard of care dietary recommendations for 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ketogenic Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor