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RECRUITING
NCT06824974
NA

Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

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?

Official title: Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-01

Completion Date

2028-12

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

BEHAVIORAL

Time-restricted eating plus healthy diet

Subjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.

Locations (1)

University of California San Diego

La Jolla, California, United States