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Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma

NCT ID: NCT06824974Sponsor: University of California, San DiegoLast updated: 2025-08-08

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?

Arms & 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.

Outcome measures

Primary

  • Adherence to protocol

    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.

    Time frame: 6 months

  • Safety from adverse events

    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.

    Time frame: 6 months

  • Ability to recruit

    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.

    Time frame: 6 months

  • Satisfaction and self-motivation

    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.

    Time frame: 6 months

Secondary

  • Effect of intervention on Quality of Life

    Time frame: 6 months

  • Effect of interventions on fasting glucose

    Time frame: 6-months

  • Sleep disturbance

    Time frame: 6 months

  • Effect of intervention on body weight

    Time frame: 6 months

  • Effect of intervention on food frequency

    Time frame: 6 months

  • Effect of intervention on Adiposity

    Time frame: 6 months

  • Effect of interventions on Physical activity

    Time frame: 6 months

  • Effect of intervention on Glucose levels

    Time frame: 6 months

  • Effect of intervention on fasting insulin

    Time frame: 6 months

  • Effect of intervention on ketone production

    Time frame: 6 months

  • Effect of interventions on hemoglobin A1c

    Time frame: 6 months

  • Effect of intervention on plasma leptin

    Time frame: 6 months

  • Effect of intervention on inflammatory cytokines

    Time frame: 6 months

  • Effect of intervention on fecal microbiome

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 3-4) 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 locations (1)

University of California San Diego

La Jolla, California, 92093

Recruiting
Nick Webster · Contact
Nick Webster, Ph.D., M.A. · Principal Investigator

References

  • Das M, Kumar D, Sauceda C, Oberg A, Ellies LG, Zeng L, Jih LJ, Newton IG, Webster NJG. Time-Restricted Feeding Attenuates Metabolic Dysfunction-Associated Steatohepatitis and Hepatocellular Carcinoma in Obese Male Mice. Cancers (Basel). 2024 Apr 16;16(8):1513. doi: 10.3390/cancers16081513.(PubMed)
  • Das M, Webster NJG. Obesity, cancer risk, and time-restricted eating. Cancer Metastasis Rev. 2022 Sep;41(3):697-717. doi: 10.1007/s10555-022-10061-3. Epub 2022 Aug 19.(PubMed)
To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients | Cancerify