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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a feasibility study that will collect data to assess the potential effect of a nutritional intervention designed to improve liver metabolism. This prospective single-site trial will enroll adult patients undergoing liver-directed therapies for hepatocellular carcinoma. Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating in which calorie consumption is limited to 8-10 hours during the day, plus targeted healthy changes in what they eat. The intervention includes dietary counseling visits with a study registered dietitian and motivational phone calls with a study Certified Health and Wellness Coach to help subjects adhere to the intervention. Individuals in the control group will be enrolled in a six-month period of observation 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 cancer? Does the intervention improve liver metabolism?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Overweight or obese (BMI 27-45 kg/m2)

• BCLC early to intermediate stage HCC

• Referred for liver-directed therapy (PTA, TACE, TARE within 3 months)

• English or Spanish speaking over the age of 18.

• ECOG Performance Status ≤ 2.

• Usual nightly fasting \<12 hours

• Willing to comply with all study procedures

• Child-Pugh A liver function.

Locations
United States
California
University of California San Diego
RECRUITING
La Jolla
Contact Information
Primary
Nick Webster, PhD
nwebster@health.ucsd.edu
858-534-6275
Backup
Tanya Shekhtman
tshekhtman@health.ucsd.edu
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2027-12
Participants
Target number of participants: 50
Treatments
Experimental: Intervention
Intervention group will follow time-restricted consumption of a healthy diet.
No_intervention: Control
Control observational arm.
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov