NCT06824974 · University of California, San Diego
Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer
(TRE+HE)
What this study is about
This is a feasibility study that will collect data to assess the potential effect of nutritional intervention. This forward-looking 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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Patients on GLP-1 receptor agonists
- 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, positive hCG urine test.
Where
- La Jolla, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations