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

Indiana University

Status: Active, not recruiting

Conditions: Cirrhosis, Liver; NASH - Nonalcoholic Steatohepatitis

Treatments: Other: Dietary consult for participants in the standard of care arm; Other: Dietary consult for participants in the ketogenic diet arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04383951

Keto Diet Study

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. NASH cirrhosis (criteria in Appendix 1) with obesity (BMI >30 kg/m2).
2. Age 18 and greater

Exclusion criteria

1. Actively participation in investigational drug treatment for non-alcoholic fatty liver disease
2. Currently taking medications for weight loss or have joined a supervised weight loss program prior to enrollment
3. Have hepatocellular carcinoma and are undergoing therapy
4. 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or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study
5. Pacemaker or implantable cardioverter devices
6. History of hepatic surgery
7. Current significant alcohol consumption, defined as more than 20 grams per day in females or 30 grams per day in males
8. Presence of ascites or hepatic encephalopathy
9. Symptomatic gastroparesis
10. Uncontrolled diabetes, as defined by a HgbA1C >11%
11. Uncontrolled congestive heart failure
12. Active infections
13. Child Turcotte Pugh score > 6
14. MELD score >12
15. Unwilling to undergo an MRI or have contraindications to an MRI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Ketogenic diet

Active Comparator group

Description:

For participants randomized to the ketogenic diet arm, a consultation with the providers of medically supervised weight loss clinic of Indiana University Health will be arranged. Subjects will be educated on the concepts of ketosis, symptoms associated with it, and dietary manipulation to achieve ketosis. Participants in this arm will use the suggested recipes in combination with strict carbohydrate monitoring though checking for urine ketone bodies. These recipes were gathered and vetted by the dietitian at the medically supervised weight loss clinic. We anticipate that this approach will allow for more calorie intake and easier carbohydrate restriction. The follow up visits will be determined by the providers of the medically supervised weight loss clinic based on the symptoms reported and subject's compliance with carbohydrate restriction.

Treatment:

Other: Dietary consult for participants in the ketogenic diet arm

Standard of Care

Sham Comparator group

Description:

For participants randomized to this arm, a consultation with the providers of medically supervised weight loss clinic will be arranged. The discussion will focus on portion control using a balanced diet. A follow up visit will be at 16 weeks. This is the extent of interventions received for participants in this arm.

Treatment:

Other: Dietary consult for participants in the standard of care arm