About this trial
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?
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Time-restricted eating plus healthy diet