Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
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- STATUS
- Recruiting
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- End date
- Dec 5, 2026
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- participants needed
- 40
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- sponsor
- Indiana University
Summary
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 | 18-100 years |
| 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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