NCT05367596

OPTIMIzing muScle Preservation in paTients wIth Cirrhosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with both cirrhosis and obesity benefit from weight loss, though patients with cirrhosis are prone to sarcopenia due to accelerated rates of protein turnover, and weight loss typically involves 20-30% of weight loss from lean mass. Prior research indicates that increased intake of high-quality protein, reduced fasting duration, and regular physical activity (particularly resistance training) can improve body composition in patients with cirrhosis. However, weight loss programming specifically tailored to retain lean mass in patients with cirrhosis has not been thoroughly investigated. Further, preliminary data suggests that alternate-day modified fasting, a form of intermittent fasting, may promote lean mass retention during weight loss. Here, this study will compare a weight loss program in patients with both Child-Pugh Class A cirrhosis and obesity using either a standard low-calorie diet (1,200 - 1,500 kcal/day) or alternate day modified fasting featuring a very-low-calorie diet 2-3 days per week for feasibility, satisfaction, and changes in body composition. Both groups will receive a behavioral weight loss program featuring portion-controlled meals and supervised group exercise.

Conditions

• Obesity
• Compensated Cirrhosis
• Sarcopenia

Interventions

Type	Name	Description
BEHAVIORAL	Continuous Energy Restriction (CER)	Energy intake will be prescribed at approximately 1,200-1,500 kcal/day with high protein. The diet will consist of low-calorie shakes provided by the study, as well as commercially available portion-controlled entrées, fruits/vegetables, and low energy-density foods available in grocery stores.
BEHAVIORAL	Alternate Day Modified Fasting (ADMF)	Enhanced Care participants will have an alternate between three days of very-low energy intake (VLED; approximately 600-800 kcal/d) and four days of healthy eating (HE) each week. On HE days, participants will consume foods ad libitum for satiety.
BEHAVIORAL	Group Health Education Sessions	Using video conferencing, all participants will attend weekly approximately 45-60 minutes group health education sessions led by a registered dietitian. The session will deliver a comprehensive nutritional and lifestyle change program to promote lifestyle changes and improve compliance.
BEHAVIORAL	Late Evening Snack	The participants will have a late evening snack with a protein supplement.
BEHAVIORAL	Physical activity	All participants will be prescribed moderate-intensity aerobic activities that do not require access to specialized exercise facilities.
BEHAVIORAL	Self-monitoring	Weekly data related to adherence, food intake, physical activity, weight measurement, and nonserious adverse events will be self-reported via a REDCap survey. Participants will also be provided with a wireless activity tracker to measure total physical activity and intensity of activity objectively. These data will be used to counsel participants in addition to providing valuable feasibility data.
BEHAVIORAL	Remotely Supervised Exercise Sessions	Sessions of 45 minutes duration will be delivered via video conferencing 2-3 times per week.

Timeline

• Start date: 2022-06-22
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2022-05-10
• Last updated: 2023-02-09

Locations

1 site across 1 country: United States