OPTIMIzing muScle Preservation in paTients wIth Cirrhosis

Study Summary

Patients with obesity and cirrhosis benefit from weight loss but are prone to sarcopenia (loss of muscle mass, strength, and function). This study proposes to test a specialized weight loss program Alternative-day Modified Fasting (ADMF) designed to promote weight loss and preserve skeletal muscle mass, strength, and function in patients with both Child-Pugh (CP) class A cirrhosis and obesity. This study will compare the effectiveness of the ADMF to Continuous Energy Restriction (CER) for 24-weeks. Both arms will receive a high-protein, high-BCAA diet, a late-night snack, supervised aerobic and resistance exercise, increased physical activity through self-monitoring, and group behavioral counseling. The primary aim of this trial is to evaluate the feasibility and acceptability of ADMF and CER for 6 months in patients with cirrhosis and obesity. The secondary aim is to compare changes in body composition in both diets.

Primary Outcome

The primary outcome is the percent of weight lost as fat-free mass at 24 weeks. Body weight and body composition (as assessed by dual x-ray absorptiometry) will be measured at baseline, week 12, and post-intervention. Percent weight loss from fat-free mass will be calculated as \[Δ fat-free mass / Δ weight loss\] for all participants who lose at least 3% of initial body weight. If \>70% of participants lose at least 80% of weight from fat mass (or no more than 20% of weight loss coming from lean

Interventions

• BEHAVIORAL Physical activity
• BEHAVIORAL Continuous Energy Restriction (CER)
• BEHAVIORAL Alternate Day Modified Fasting (ADMF)
• BEHAVIORAL Group Health Education Sessions
• BEHAVIORAL Late Evening Snack