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Tests a nightly fasting and healthy eating plan in liver disease or liver cancer

Tests nightly fasting plus healthy eating in adults with fatty liver or liver cancer.

Key facts

Who runs it
University of California, San Diego
Where
La Jolla, United StatesSee the site
Trial code
Registry title
Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer
Status
Recruiting
People taking part
50 people, planned
Started
1 Aug 2025
Expected to end
Dec 2028
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Time-restricted eating plus healthy diet
Record updated
25 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a fatty liver disease, cirrhosis or early to intermediate liver cancer who are overweight or obese. It tests a nightly fast plus a healthy diet.

Age
Over 18 years
Sex
All sexes
Disease stage
Fatty liver disease (MASLD/NAFLD or MASH), cirrhosis, or liver cancer (HCC) at BCLC early to intermediate stage. BMI 27-45 kg/m2. ECOG Performance Status ≤ 2.
Earlier treatment
Not in another trial of an investigational agent within the prior 30 days. Not on GLP-1 receptor agonists. No unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy.

Main reasons for not taking part

  • Advanced liver cancer, metastatic disease, tumor in vein or ascites
  • Advanced cirrhosis (Child-Pugh B+C)
  • Type 1 diabetes or low blood sugar events
  • Another cancer in the last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Overweight or obese (BMI 27-45 kg/m2)
  • Diagnosed with metabolic-dysfunction associated steatitic liver disease (MASLD/NAFLD), metabolic-dysfunction associated steatohepatitis, cirrhosis or liver cancer (BCLC early to intermediate stage HCC)
  • 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
  • Life expectancy of > 12 months

Who cannot take part

  • Medications that markedly impact metabolic study biomarkers
  • Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
  • Participation in a trial of an investigational agent within the prior 30 days
  • Metastatic disease, tumor in vein, or ascites
  • Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
  • Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
  • 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
  • Advanced HCC, progression, and/or associated comorbidities
  • Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C)
  • Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
  • Participation in another conflicting study that requires modification of diet or food timing
  • Patients on GLP-1 receptor agonists
  • Active alcohol abuse or less than 6 months of sobriety
  • Pregnancy or lactating, positive hCG urine test

Where in United States

  • University of California San DiegoLa Jolla, United StatesContact: Nick WebsterTaking people

About the trial

What the trial wants to find out

This is a feasibility study that will collect data to assess the potential effect of nutritional intervention. This prospective single-site trial will enroll adult patients with liver diseases such as metabolic-dysfunction associated steatotic liver disease (MASLD), metabolic-dysfunction associated steatohepatitis (MASH), cirrhosis and/or hepatocellular carcinoma (HCC). Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating plus targeted healthy changes in what they eat (TR-HE). The intervention includes dietary counseling visits with a study registered dietitian (RD) and motivational phone calls with a study Certified Health and Wellness Coach (HC). Individuals who are randomized to the control group or who elect to join the control group will be enrolled in a six-month period of observation and phlebotomy only. The main questions it aims to answer are:

Read full original descriptionShow less

Is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver disease or cancer? Does the intervention improve liver metabolism?

The 2 groups in the trial

  • InterventionTreatment being tested

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

    Treatment: Time-restricted eating plus healthy diet

  • ControlNo study treatment, for comparison

    Control observational arm.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
Plain-language title
Tests a nightly fasting and healthy eating plan in liver disease or liver cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 June 2026