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

NAActive, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 15, 2020

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2026

Conditions
NASH - Nonalcoholic SteatohepatitisCirrhosis, Liver
Interventions
OTHER

Dietary consult for participants in the ketogenic diet arm

An initial consultation with the providers of medically supervised weight loss clinic will be arranged. Participants in the ketogenic diet group will be educated on the concepts of the diet and will be provided with recipes to be utilized at home that adhere to this diet. In addition to the initial consultation, participants in this arm receive additional consultations with these providers with a frequency as determined by the provider.

OTHER

Dietary consult for participants in the standard of care arm

For participants in the standard of care arm, an initial consultation with the providers of medically supervised weight loss clinic will be arranged and the discussion will center around portion control using a balanced diet. Participants will receive only one additional consultation with the provider 16 weeks later just prior to the conclusion of the study.

Trial Locations (1)

46202

Indiana University School of Medicine, Indianapolis

All Listed Sponsors
lead

Indiana University

OTHER