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Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2020-08-15
Completion Date
2026-12-31
Last Updated
2025-03-10
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
Indiana University School of Medicine
Indianapolis, Indiana, United States