Actively Recruiting
To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients
Led by University of California, San Diego · Updated on 2025-08-08
50
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Overweight or obese with BMI 27-45 kg/m2
- Early to intermediate stage hepatocellular carcinoma (BCLC stage)
- Referred for liver-directed therapy (PTA, TACE, TARE) within 3 months
- English or Spanish speaking adults over 18 years old
- ECOG Performance Status 2 or less
- Usual nightly fasting less than 12 hours
- Willing to follow all study procedures
- Child-Pugh A liver function
You will not qualify if you...
- Advanced hepatocellular carcinoma, progression, metastatic disease, tumor in vein, or ascites
- Advanced cirrhosis (Child-Pugh B or C) or poorly controlled hepatic encephalopathy (grade 3-4)
- Type 1 diabetes or history of hypoglycemia or hypoglycemic events by CGM
- Participation in another study requiring diet or food timing changes
- Uncontrollable eating patterns (e.g., wasting, Night Eating Syndrome, disordered eating, food insecurity)
- Use of medications affecting metabolic study biomarkers
- Other cancers in last 10 years except nonmelanoma skin cancer or cervix carcinoma in situ
- Serious medical conditions interfering with study participation (e.g., chronic kidney disease, heart failure)
- Unresolved toxicity grade 2 or higher from previous anti-cancer therapy
- Active alcohol abuse or less than 6 months sobriety
- Participation in investigational drug trial within prior 30 days
- Pregnancy or lactating
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
N
Nick Webster, PhD
CONTACT
T
Tanya Shekhtman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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