To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients
Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
University of California, San Diego
50 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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.
Exclusion Criteria12
- Advanced HCC, progression, and/or associated comorbidities, metastatic disease, tumor in vein, or ascites
- Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C). Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
- Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
- Participation in another conflicting study that requires modification of diet or food timing.
- Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
- Medications that markedly impact metabolic study biomarkers.
- Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
- Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.
- Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
- Active alcohol abuse or less than 6 months of sobriety
- Participation in a trial of an investigational agent within the prior 30 days
- Pregnancy or lactating
Interventions
Subjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06824974