NCT06824974Recruiting
Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer
Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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: 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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- 1 Aug 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- University of California, San Diego
- NCT number
- NCT06824974
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Aug 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.