OPTIMIzing muScle Preservation in paTients wIth Cirrhosis

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.

Conditions

• Obesity
• Compensated Cirrhosis
• Sarcopenia

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.

Sponsors & Collaborators

• University of Kansas Medical Center

  lead OTHER

Principal Investigators

• Winston Dunn, MD · KUMC

• Felicia Felicia Steger, PhD · KUMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-22

Primary Completion

2022-12-16

Completion

2022-12-16

Countries

• United States

Study Locations