Time-Restricted Eating for Liver Cancer
(TRE+HE Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it excludes those on medications that significantly affect metabolic study markers. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Time-restricted eating plus healthy diet for liver cancer?
Is time-restricted eating safe for humans?
Research on time-restricted eating in animals suggests it may have protective effects against cancer and improve liver health, but it can also increase collagen deposits and enhance certain cancer risks in specific conditions. While these studies provide insights, more research is needed to confirm safety in humans.12346
How does time-restricted eating plus a healthy diet differ from other treatments for liver cancer?
Time-restricted eating combined with a healthy diet is unique because it focuses on limiting the hours during which food is consumed, which may help prevent liver cancer by reducing inflammation and supporting the liver's natural rhythms. This approach is different from traditional treatments that often involve medication or surgery, as it uses dietary timing and nutrition to potentially slow cancer progression.278910
What is the purpose of this trial?
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?
Research Team
Nick Webster, PhD
Principal Investigator
Universoty of California San Diego
Eligibility Criteria
This trial is for adults with liver cancer, specifically hepatocellular carcinoma, who may also be overweight or have fatty liver disease. Participants should be undergoing liver-directed therapies and willing to follow a nutritional program including time-restricted eating and diet changes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the intervention group follow a six-month nutritional change program with time-restricted eating and dietary counseling, while the control group undergoes observation.
Follow-up
Participants are monitored for safety, adherence, and various health outcomes such as insulin levels, glucose levels, and quality of life.
Long-term follow-up
Assessment of disease progression and tumor regression or recurrence using LI-RADS-TR.
Treatment Details
Interventions
- Time-restricted eating plus healthy diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor