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

R
Raj Vuppalanchi, MD

Primary Investigator

Overview

The purpose of this study is to see how following the keto diet affects the health of the liver.

Description

Participants will have a total of 7 study visits in 3 phases: initial (includes 2 visits for baseline, screening and randomization), study intervention (includes 3 visits and lasts about 16 weeks) and then a safety phase (1 telephone call at about 1-2 weeks after finished with the study).
The screening visit will include: questions about health, medical record review, vitals, blood and stool samples. Baseline visit will include: vitals, health questions, physical exam, 2 questionnaires about health and eating habits, ECG, VCTE, body composition analysis, MRI, blood samples, visit with dietician, DEXA scan (must also enroll in FIT study for this scan and to participate in this study). At this point, participants will also be randomly assigned to either standard care (be taught about portion control and weight loss) or keto diet (receive education about the keto diet and recipes to use that follow these guidelines, plus be medically supervised by members of the weight loss program).
3 additional visits (1-4 weeks later, 5-15 weeks later, 16 weeks later) will include: vitals; questionnaires; blood, urine, and stool samples; questions about mood and how participants are feeling.
The follow-up visit 17-18 weeks later will be via phone, asking participants questions about their health and medicines they're taking.
 

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Obesity, NASH Cirrhosis, Keto
  • Age: Between 18 Years - 100 Years
  • Gender: All

Individuals at least 18 years of age with NASH cirrhosis and obesity, who agree to also participate in the FIT study.
Individuals currently taking medications for weight loss, undergoing therapy for hepatocellular carcinoma, with history of hepatic surgery, with current significant alcohol consumption, with pacemaker or cardioverter devices, with uncontrolled diabetes, congestive heart failure, or active infections will not be eligible.
Women who are pregnant will not be eligible.

Updated on 02 May 2024. Study ID: 1904651940
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