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

NCT06824974 | Recruiting

• 1 other identifier: #808859
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Keywords

Time-restricted eating; healthy diet

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  6 months

Secondary Outcomes (14)

• Effect of intervention on Quality of Life

  6 months

• Effect of interventions on fasting glucose

  6-months

• Sleep disturbance

  6 months

• Effect of intervention on body weight

  6 months

• Effect of intervention on food frequency

  6 months

Other Outcomes (1)

• Disease progression as a Tertiary/Exploratory outcome

  12-months

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group will follow time-restricted consumption of a healthy diet.

Behavioral: Time-restricted eating plus healthy diet

Control

NO INTERVENTION

Control observational arm.

Interventions

Time-restricted eating plus healthy diet BEHAVIORAL

Subjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight or obese (BMI 27-45 kg/m2)
• BCLC early to intermediate stage HCC
• Referred for liver-directed therapy (PTA, TACE, TARE within 3 months)
• English or Spanish speaking over the age of 18.
• ECOG Performance Status ≤ 2.
• Usual nightly fasting \<12 hours
• Willing to comply with all study procedures
• Child-Pugh A liver function.

You may not qualify if:

• Advanced HCC, progression, and/or associated comorbidities, metastatic disease, tumor in vein, or ascites
• Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C). Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
• Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
• Participation in another conflicting study that requires modification of diet or food timing.
• Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
• Medications that markedly impact metabolic study biomarkers.
• Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
• Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.
• Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
• Active alcohol abuse or less than 6 months of sobriety
• Participation in a trial of an investigational agent within the prior 30 days
• Pregnancy or lactating

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 38672595 BACKGROUND

• 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.

  PMID: 35984550 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Obesity; Overweight; Intermittent Fasting

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nick Webster, PhD

  Universoty of California San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nick Webster, PhD

CONTACT

858-534-6275; nwebster@health.ucsd.edu

Tanya Shekhtman

CONTACT

tshekhtman@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 13, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)