To Test Whether Time-restricted Eating Coupled with a Healthy Diet is Beneficial in Liver Cancer Patients

Not Applicable

Not yet recruiting

• Conditions: Liver Cancer, Adult; MASH - Metabolic Dysfunction-Associated Steatohepatitis; Obesity and Overweight

• Registration Number: NCT06824974
• Lead Sponsor: University of California, San Diego

Brief 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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-04
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to protocol	6 months	Participant adherence to and comprehension of the protocol as an indicator of intervention delivery by staff. Adherence will be assessed by the number of participants who complete the study, the percentage of days with fasting \>14 h, and the number of days that food was logged into the app.
Safety from adverse events	6 months	Safety assessed by adverse events and liver function tests. Reports on adverse events will include hypoglycemic epidoes, nausea, disrupted sleep, decreased quality of life or other patient reported events from surveys. Liver function tests (AST and ALT) as well ss platelet count and total protein are monitored under SOC. AST and ALT elevation will be considered mild if 2-5 times upper limit normal (ULN), moderate if 5-15 times ULN, and severe if \>15 times ULN.
Ability to recruit	6 months	Ability to recruit our target population will be assessed by the number of eligible individuals in the patient population, and the number who enroll in the trial.
Satisfaction and self-motivation	6 months	We will determine the degree to which participants liked the intervention through satisfaction surveys at the end of the study and the number of participants who demonstrate self-motivation to continue the intervention protocol during 6-month follow-up.

Secondary Outcome Measures

Name	Time	Method
Effect of intervention on Quality of Life	6 months	Quality of Life will be assessed using the EORTC QLQ C-30 questionnaire for Cancer patients
Effect of interventions on fasting glucose	6-months	Fasting glucose will be measured at baseline and 6 months
Sleep disturbance	6 months	Sleep disturbance as reported by the PROMIS-8b survey
Effect of intervention on body weight	6 months	Body weight will be measured prior to and during intervention
Effect of intervention on food frequency	6 months	Participants will complete a Food frequency questionnaire at Baseline, 3 months and 6 months
Effect of intervention on Adiposity	6 months	Adiposity will be measured by Dual-energy X-ray Absorptiometry (DXA) at baseline and at 6 months
Effect of interventions on Physical activity	6 months	Physical activity will be measured by Accelerometer mounted at the waist at baseline and at 6 months
Effect of intervention on Glucose levels	6 months	Glucose levels will be monitored by Continuous Glucose Monitoring at baseline and at 6 months
Effect of intervention on fasting insulin	6 months	Fasting insulin levels will be measured at baseline and at 6 months
Effect of intervention on ketone production	6 months	Fasting beta-hydroxybutyrate levels will be measured at baseline and 6 months
Effect of interventions on hemoglobin A1c	6 months	Hemoglobin A1c will be measured at baseline and 6 months
Effect of intervention on plasma leptin	6 months	Leptin levels will be measured at baseline and 6 months
Effect of intervention on inflammatory cytokines	6 months	Inflammatory cytokines will be measured at baseline and 6 months
Effect of intervention on fecal microbiome	6 months	7S sequencing will be performed on fecal samples at baseline and 6 months

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States