Time-restricted eating plus a healthy diet for people with liver cancer
Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
This trial will try an 8–10 hour time-restricted eating plan together with targeted healthy food changes for overweight adults with early-to-intermediate liver cancer who are having liver-directed therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06824974 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-site randomized feasibility trial at UC San Diego enrolling adults with early-to-intermediate hepatocellular carcinoma who are overweight or obese. Participants randomized to the intervention will follow a six-month program combining time-restricted eating (8–10 hour daily eating window) and targeted healthy dietary changes with regular counseling from a registered dietitian and motivational calls from a certified health and wellness coach. The control group will have six months of observation without the dietary intervention. The trial will collect safety, adherence, and metabolic outcomes to see if the approach is practical and safe in this patient population.
Who should consider this trial
Good fit: Ideal candidates are English- or Spanish-speaking adults aged 18+ with BMI 27–45 kg/m2, BCLC early-to-intermediate HCC referred for liver-directed therapy within 3 months, ECOG ≤2, Child-Pugh A, and who typically fast less than 12 hours nightly.
Not a fit: Patients with advanced HCC or metastatic disease, advanced cirrhosis (Child-Pugh B/C), uncontrolled hepatic encephalopathy, type 1 diabetes or recurrent hypoglycemia, severe eating disorders or food insecurity, conflicting diets/medications, or other active cancers are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could improve liver metabolism, support weight management, and potentially enhance recovery or outcomes around liver-directed therapies.
How similar studies have performed: Time-restricted eating has shown metabolic and liver-related benefits in general and in fatty liver disease populations, but its safety and feasibility specifically in people undergoing liver-directed therapy for HCC remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 3-4) hepatic encephalopathy 3. Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM 4. Participation in another conflicting study that requires modification of diet or food timing. 5. Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity) 6. Medications that markedly impact metabolic study biomarkers. 7. Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ) 8. Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial. 9. Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy 10. Active alcohol abuse or less than 6 months of sobriety 11. Participation in a trial of an investigational agent within the prior 30 days 12. Pregnancy or lactating
Where this trial is running
La Jolla, California
- University of California San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Nick Webster, PhD — Universoty of California San Diego
- Study coordinator: Nick Webster, PhD
- Email: nwebster@health.ucsd.edu
- Phone: 858-534-6275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.