This is a feasibility study that will collect data to assess the potential effect of nutritional intervention. This prospective single-site trial will enroll adult patients with liver diseases such as metabolic-dysfunction associated steatotic liver disease (MASLD), metabolic-dysfunction associated steatohepatitis (MASH), cirrhosis and/or hepatocellular carcinoma (HCC). Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating plus targeted healthy changes in what they eat (TR-HE). The intervention includes dietary counseling visits with a study registered dietitian (RD) and motivational phone calls with a study Certified Health and Wellness Coach (HC). Individuals who are randomized to the control group or who elect to join the control group will be enrolled in a six-month period of observation and phlebotomy only. The main questions it aims to answer are:
Is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver disease or cancer? Does the intervention improve liver metabolism?
Overweight or obese (BMI 27-45 kg/m2)
Diagnosed with metabolic-dysfunction associated steatitic liver disease (MASLD/NAFLD), metabolic-dysfunction associated steatohepatitis, cirrhosis or liver cancer (BCLC early to intermediate stage HCC)
English or Spanish speaking over the age of 18.
ECOG Performance Status ≤ 2.
Advanced HCC, progression, and/or associated comorbidities
Metastatic disease, tumor in vein, or ascites
Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C).
Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
Parallel
Time-restricted eating plus healthy diet
BehavioralSubjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.
Adherence to protocol
Participant adherence to and comprehension of the protocol as an indicator of intervention delivery by staff. Adherence will be assessed by the number of participants who complete the study, the percentage of days with fasting \>14 h, and the number of days that food was logged into the app.
Safety from adverse events
Safety assessed by adverse events and liver function tests. Reports on adverse events will include hypoglycemic epidoes, nausea, disrupted sleep, decreased quality of life or other patient reported events from surveys. Liver function tests (AST and ALT) as well ss platelet count and total protein are monitored under SOC. AST and ALT elevation will be considered mild if 2-5 times upper limit normal (ULN), moderate if 5-15 times ULN, and severe if \>15 times ULN.
Ability to recruit
Ability to recruit our target population will be assessed by the number of eligible individuals in the patient population, and the number who enroll in the trial.
Satisfaction and self-motivation
We will determine the degree to which participants liked the intervention through satisfaction surveys at the end of the study and the number of participants who demonstrate self-motivation to continue the intervention protocol during 6-month follow-up.
Effect of intervention on Quality of Life
Quality of Life will be assessed using the EORTC QLQ C-30 questionnaire for Cancer patients
Effect of interventions on fasting glucose
Fasting glucose will be measured at baseline and 6 months
Sleep disturbance
Sleep disturbance as reported by the PROMIS-8b survey
Effect of intervention on body weight
Body weight will be measured prior to and during intervention
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