To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients
Part of paid clinical trials in La Jolla, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT06824974
- Status
- Recruiting
Conditions
- Liver Cancer, Adult
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Obesity and Overweight
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Time-restricted eating plus healthy diet — BEHAVIORALSubjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.
Study Details
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?
Key Dates
- Start date
- Aug 31, 2025
- Status verified
- Aug 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: InterventionIntervention group will follow time-restricted consumption of a healthy diet.
- No Intervention: ControlControl observational arm.
Primary Outcome Measure
Adherence to protocol [ Time Frame: 6 months ]
Central Contacts
- Nick Webster, PhD858-534-6275
- Tanya Shekhtman
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | Nick Webster, Ph.D., M.A. (PRINCIPAL_INVESTIGATOR) |
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