Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
University of California, San Diego
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Overweight or obese (BMI 27-45 kg/m2) 2. BCLC early to intermediate stage HCC 3. Referred for liver-directed therapy (PTA, TACE, TARE within 3 months) 4. English or Spanish speaking over the age of 18. 5. ECOG Performance Status ≤ 2. 6. Usual nightly fasting \<12 hours 7. Willing to comply with all study procedures 8. Child-Pugh A liver function. Exclusion Criteria: 1. Advanced HCC, progression, and/or associated comorbidities, metastatic disease, tumor in vein, or ascites 2. Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C). Poorly controlled or refractory (grade 3…
Interventions
- BehavioralTime-restricted eating plus healthy diet
Subjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.
Location
- University of California San DiegoLa Jolla, California