OPTIMIzing muScle Preservation in paTients wIth Cirrhosis

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 22, 2022

Primary Completion Date

December 16, 2022

Study Completion Date

December 16, 2022

Conditions
ObesityCompensated CirrhosisSarcopenia
Interventions
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.

Trial Locations (1)

66160

University of Kansas Medical Center, Kansas City

All Listed Sponsors
lead

University of Kansas Medical Center

OTHER