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

STATUS

Recruiting
End date

Dec 5, 2026
participants needed

40
sponsor

Indiana University

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Updated on 19 February 2024

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cirrhosis

ketogenic diet

fatty liver

Summary

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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.

Description

The primary aim is to assess the safety of ketogenic diet as compared to standard of care approach for weight loss in patients with compensated cirrhosis due to NASH. The safety endpoints captured in the study include liver decompensation events, measured through several questionnaires, fasting blood glucose, serum creatinine, fasting lipid profile and other adverse events. The tolerability of the ketogenic diet will be assessed by study compliance and by administering a questionnaire.

Secondary aims include weight loss, changes in body composition via serial use of bioelectrical impedance via an Inbody Machine, changes in liver fat and liver stiffness using MRI and proton density fat fraction (MRI-PDFF), liver biochemistries, changes in Child-Turcotte-Pugh and MELD scores measured via labs and changes in liver steatosis and stiffness via serial measures of VCTE by FibroScan.

Details

Condition	Cirrhosis, NASH - Nonalcoholic Steatohepatitis
Age	18years - 100years
Treatment	Dietary consult for participants in the ketogenic diet arm, Dietary consult for participants in the standard of care arm
Clinical Study Identifier	NCT04383951
Sponsor	Indiana University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	NASH cirrhosis (criteria in Appendix 1) with obesity (BMI >30 kg/m2)
	Age 18 and greater
Exclusion Criteria
	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

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