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

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04383951
• Other study ID #: Keto Diet Study
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: Emily Smith, BS
• Phone: 317-274-1692
• Email: es37[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease
• Weight Loss

Intervention

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.
• 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

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood chemistry to assess for liver de-compensation events	Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.	Blood chemistry tests will be assessed at the initial visit.
Primary	Blood chemistry to assess for liver de-compensation events	Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.	Blood chemistry tests will be assessed at the study visits between weeks 5 and 14.
Primary	Blood chemistry to assess for liver de-compensation events	Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.	Blood chemistry tests will be assessed at the Week 16 visit.
Primary	Adverse events	All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.	All participants will be monitored at the study visits between weeks 5 and 14 and all participants will be instructed to alert the study team for additional information if such an event occurs.
Primary	Adverse events	All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.	All participants will be monitored at the week 16 visit and all participants will be instructed to alert the study team for additional information if such an event occurs.
Primary	Tolerability of the ketogenic diet	How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.	The POMS 40 questionnaire is administered at the initial visit.
Primary	Tolerability of the ketogenic diet	How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.	The POMS 40 questionnaire is administered at the study visits between weeks 1 and 4.
Primary	Tolerability of the ketogenic diet	How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.	The POMS 40 questionnaire is administered at the Week 16 visit.
Secondary	MRI with proton density fat fraction (PDFF)	MRI-PDFF is a convenient method for liver fat quantification and currently used in most clinical trials, as it only requires a single 20-second breath hold and an estimated time of about 5 minutes in an MRI scanner suite. MRI in the study will be used to quantify liver steatosis, stiffness, and body composition.	Performed at initial visit and at week 16 visit
Secondary	Weight loss and change in body composition	Changes in weight and body composition will be measured via serial use of a scale and use of bioelectrical impedance via an Inbody machine	Performed at initial visit and at week 16 visit
Secondary	Changes in liver stiffness and steatosis	Changes in liver stiffness and steatosis will be measured with serial use of vibration controlled transient elastography (VCTE) via a FibroScan.	Performed at initial visit and at week 16 visit