RecruitingNot ApplicableNCT06824974

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

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

Sponsor

University of California, San Diego

Enrollment

50 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity and Overweight Liver Cancer, Adult MASH - Metabolic Dysfunction-Associated Steatohepatitis

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?

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether time-restricted eating (eating only within a set window of time each day, such as 8 hours) combined with healthy eating education can improve metabolic health — including weight, blood sugar, and cholesterol levels — compared to education alone. **You may be eligible if...** - You are 18 or older - You have overweight, obesity, or metabolic concerns like prediabetes or high cholesterol - You are not currently following a structured diet program - You are able to track your eating patterns using an app - You do not do shift work that would make consistent meal timing difficult **You may NOT be eligible if...** - You have type 1 diabetes - You have a current eating disorder - You are pregnant or breastfeeding - You have serious kidney, liver, or heart disease - You are taking insulin or medications that require eating at specific times Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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