Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
University of California, San Diego
Summary
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?
Description
We are proposing a feasibility study that will collect data to assess the potential effect of nutritional intervention in adult patients with liver disease. We hypothesize that a time-restricted, healthy eating intervention is feasible and safe;will improve metabolic and inflammatory biomarkers, and quality of life. Primary endpoint is to assess feasibility and safety. Feasibility assessment includes recruitment, retention, and satisfaction of subject; data collection efficiency; adherence to TR+HE protocols by dietary logs and/or dietary recalls. Safety assessment includes liver function tes…